Liberation and Discharge Status of Older Patients After Invasive Mechanical Ventilation: A Retrospective cohort study

doi:10.21203/rs.3.rs-4834931/v1

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Liberation and Discharge Status of Older Patients After Invasive Mechanical Ventilation: A Retrospective cohort study

https://doi.org/10.21203/rs.3.rs-4834931/v1

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Background

Data on the proportion of patients liberated from invasive mechanical ventilation (IMV) and the prognosis of those who have undergone IMV are limited. Objective data on prognosis are important when discussing preference for IMV. Therefore, this study explored both the proportion of liberation and prognosis after IMV in older patients in Japan.

Methods

We conducted a retrospective cohort study using claim data from April 2014 to March 2019 from the National Health Insurance, Late Elders' Health Insurance, and Long-Term Care Insurance in Tsukuba City, Japan. Patients aged ≥ 65 years who underwent IMV were included and patients who died within 3 days after intubation were excluded. A descriptive analysis of the liberation and the discharge status on Day 180 was conducted including a stratification by age categories and care level (CL) < 3 or ≥ 3. The chi-square or Fisher’s exact tests were conducted to assess whether liberation and discharge status differed among age categories or CLs.

Results

In total, 272 patients were included in the study, and the median age was 78 years (interquartile range: 73–84). The median duration of mechanical ventilation was 9.0 days. Pneumonia was the most frequent main diagnosis (12.5%). In total, 73.5% achieved liberation and 42.6% were discharged alive until day 180, while 19.9% were hospitalized and 37.5% were deceased on day 180. The proportion of liberation did not differ among age categories and CLs. However, the IMV duration for those requiring CL ≥ 3 was longer, and the proportion of hospitalized patients on day 180 among patients who requiring CL ≥ 3 was significantly higher than that in patients requiring CL < 3 (35.1% vs 17.4%, p = 0.012).

Conclusions

This study shows that many older patients can be successfully liberated from IMV. However, one third of patients died in the hospital and one fifth of patients required prolonged hospitalization. IMV and hospitalization were likely to be longer among patients requiring CL ≥ 3. Therefore, it may be important to discuss not only the potential difficulty of liberation, but also to convey the risks of undesired outcomes and physical function decline when considering IMV.

Invasive mechanical ventilation

liberation

prognosis

long-term care level

older patients

Japan

Claim date

Liberation of older patients from invasive mechanical ventilation (IMV) is occasionally challenging. Implementation of IMV is sometimes avoided in conventional practice in Japan, given the risk of mechanical ventilation (MV)-dependency, while discontinuation of IMV after its implementation is avoided for fear of litigation [1].

The burden of treatment, including the length of the hospital stay, extent of testing and invasiveness of interventions, and the likelihood of the outcome, influence treatment preferences among older patients with limited life expectancy [2]. Decisions about treatment plans should be based on a shared understanding of prognosis between patients, clinicians, and patients’ families and surrogates [3]. Therefore, when clinicians discuss the use of IMV with patients and their families, objective data on prognosis should be shared. However, data on the proportion of liberation among older patients are scarce. One single-center study has reported that the proportion of liberation among older patients (aged ≥ 65 years) with community-acquired pneumonia was 48% [4]. Moreover, even if liberation is achieved, it has been reported that the level of care required increases in older patients after MV [5], and that physical function may decrease after intensive care unit (ICU) management, such as MV [6]. These factors may affect the period of hospitalization and the discharge destination. Previous studies have reported that in-hospital mortality rates of patients in whom IMV was initiated in the emergency department were 24–27% for all ages [7, 8], 33–35% for older patients (aged ≥ 65 years) [9, 10], and 42% for those aged ≥ 80 years who were transferred to emergency medical centers [11].

Given the paucity of data on the rates and outcomes of liberation from IMV, this study aimed to clarify prognosis, according to age and the level of long-term care required, in older patients who underwent IMV in Japan, which had the longest life expectancy in the world in 2019 [12].

Data source

We conducted a retrospective cohort study using claim data from the National Health Insurance, Late Elders' Health Insurance, and Long-Term Care Insurance in Tsukuba City, Ibaraki, Japan, which is a suburban medium-sized city with a population of 236,842, including 23,994 aged 65–74 years and 21,506 aged ≥ 75 years [13]. Data sets obtained between April 2014 to March 2019 were analyzed.

Japan’s statutory health insurance system consists of two types of mandatory insurance: employment-based plans and residence-based insurance plans [14]. For individuals aged < 75 years, one of these two types of insurance is selected, based on their employment status. Unemployed individuals, excluding the dependents of employed individuals, are covered by residence-based insurance plans, i.e., the National Health Insurance. The proportion of individuals covered by the National Health Insurance among those who were aged 65–74 years in Tsukuba City was 72.9% in 2016 [15]. Individuals aged ≥ 75 years are all automatically covered by residence-based insurance plans, named the Late Elders' Health Insurance. Although recipients of public assistance are excluded from these medical insurance systems, the proportion of recipients of public assistance among the population aged ≥ 65 years is very small. (In Ibaraki Prefecture, the proportion of recipients of public assistance among those aged ≥ 65 years is estimated at about 0.15% [16–18].) The dataset we used covers a considerable proportion of individuals who were aged ≥ 65 years.

The long-term care insurance system in Japan covers persons aged ≥ 65 years as insured persons who could be supported when requiring long-term care or support [19]. Municipalities, who are the insurers, provide long-term care requirement certification or support requirement certification based on voluntary application. Standards for long-term care requirement certification are uniformly and objectively determined nationwide. After receiving initial certification, it has to be updated every 2 years to obtain continued support. Seven levels of long-term care requirement are defined: support levels 1–2 and care need levels 1–5, with care need level 5 being the most severe condition requiring the longest care. The level of long-term care required has been correlated with the Barthel Index, with median Barthel Index scores (interquartile range) by care level (CL) being as follows: CL3, 60 (40–75); CL4, 30 (20–40); and CL5, 20 (5–35) [20].

The study protocol was approved by the Ethics Committee, Faculty of Medicine, University of Tsukuba (approval number: 1445-13, date of approval: 21 September 2023). Data were anonymized prior to being provided to the researchers; thus, the need for obtaining informed consent was waived.

Participants

Patients aged ≥ 65 years who underwent IMV were included. Patients with a claim of medical reimbursement classification code “lifesaving endotracheal intubation” (procedure code J044) and “artificial ventilation” (J045) on the same day or day after intubation was defined as patients who received IMV. “Lifesaving endotracheal intubation” (J044) does not include intubation associated with surgical anesthesia. “Artificial ventilation” (J045) includes not only IMV, but also non-invasive MV in patients with acute respiratory failure with PaO₂ / FiO₂ ≤ 300 mmHg or PaCO₂ ≥ 45 mmHg, as well as intubation associated with surgical anesthesia. Using the combination of these two procedure codes, only patients with IMV intubated outside the operating room could be included. Patients, since the decision-making regarding the initiation of IMV associated with surgical anesthesia differs significantly from decision-making in patients requiring emergency endotracheal intubation were intended to include as objective.

In patients with multiple intubation records, only the data of the first episode was used. Patients who experienced tracheotomy or home MV before the first intubation record, and who had been in the hospital for less than 180 days after intubation at the study cutoff date, March 31, 2019 were all excluded. Patients who died within 3 days after intubation were also excluded, because early deaths are mostly due to the progression of the primary diagnosis with few impacts of complications from intensive care, and at least 3 days are necessary to properly observe the trajectory after MV [21].

Extracted data items

Data were extracted regarding the age, sex, main diagnosis recorded on receipt (multiple diagnoses could exist), past medical history, the level of long-term care required, the duration of MV, tracheotomy followed by MV management after intubation, the days of tracheotomy from intubation, and liberation and discharge status on day 180. The main diagnosis recorded on receipt was categorized using the ICD-10 code, based on previous research [22–25]. Patients who underwent open and closed chest cardiac massage were classified as having a diagnosis of cardiopulmonary arrest. The procedure codes and ICD-10 codes we used to determine each procedure and diagnosis are summarized in Appendix 1. Age was categorized into three categories: 65–74 years, 75–84 years, and ≥ 85 years. The level of long-term care required was extracted from the latest long-term care requirement certification records before intubation, which is updated every 2 years from the initial certification.

The level of long-term care required was divided into two categories based on a previous study, which classified CL based on the degree of bedriddenness and the level of independence of older individuals with dementia [26]. They revealed that among older individuals requiring CL ≥ 3, more than half were bedridden, and more individuals exhibited a functional decline in both level of independence among patients with dementia and degree of bedriddenness compared to other patients. Therefore, patients classified CL < 3 (including no certification) was categorized as mild to moderate, and CL ≥ 3 as severe.

Liberation was defined as liberation from MV without any implication about extubation. If there was an interruption in the MV record of ≤ 3 days during MV management, we considered it as a continuous MV period.

Analyses

A descriptive analysis of the liberation and discharge status was conducted. Data were analyzed using descriptive statistics, including frequency counts, percentages, median, and graphical representations. Liberation and discharge status were summarized as changes over time until day 180. If patients achieved liberation even once, they were treated as liberated patients, even if they underwent MV again 4 or more days after the end of the initial MV.

The stratified results of liberation and discharge status by age categories and CL ≥ 3 or < 3 are also presented. We conducted chi-square test or Fisher’s exact test to assess whether liberation and discharge status differed among age categories or CLs.

Among the 1,507 patients with the “Artificial ventilation” code, 591 also had “Lifesaving endotracheal intubation” code assigned on the same day or one day previously. Seventeen patients were excluded based on the exclusion criteria: two patients underwent home MV before intubation, two underwent tracheotomy before intubation, and thirteen remained in the hospital but had been hospitalized for less than 180 days after intubation by the final day of the observation period. In addition, 302 patients who died within 3 days after intubation were excluded. Finally, 272 patients who were alive on day 4 after initiating IMV were included. The details of the selection process are described in Fig. 1.

The characteristics of the included patients are summarized in Table 1. Among the 272 included patients, the median age was 78 (interquartile range [IQR]: 73–84) and almost one-quarter were > 85 years old. Almost two-thirds were male. The most frequent main diagnosis was pneumonia, followed by cerebrovascular diseases, and cardiopulmonary arrest. More than one-third had a history of chronic lung disease and almost 30% had a history of neuromuscular disease. More than 10% of cases were certified as CL ≥ 3 before intubation. The median duration of MV was 9.0 days. Almost one-quarter underwent tracheotomy during the MV period, at a median of 11.0 days after starting ventilation.

Table 1

Characteristics of the included cases
	All participants, n = 272
Age (years)	78	(73–84)
Age categories (years)
65–74	87	(32.0)
75–84	123	(45.2)
≥ 85	62	(22.8)
Sex: male	169	(62.1)
Admission diagnosis
Pneumonia	34	(12.5)
Cerebrovascular disease	31	(11.4)
Cardiopulmonary arrest	26	(9.6)
Heart failure	25	(9.2)
Ischemic heart disease	18	(6.6)
Head and neck trauma	14	(5.1)
Sepsis	14	(5.1)
Cancer	11	(4.0)
Others	34	(12.5)
Past medical history
Chronic lung disease	102	(37.5)
Neuromuscular disease	77	(28.3)
Ischemic heart disease	97	(35.7)
Heart failure	94	(34.6)
Cerebrovascular disease	111	(40.8)
Level of long-term care required: Care level ≥ 3	37	(13.6)
Hospitalized from long-term care facilities	20	(7.4)
Duration of mechanical ventilation (days)	9.0	(4.5–18.5)
Tracheotomy after intubation	60	(22.1)
Duration from intubation to tracheotomy (days)	11.0	(8.5–15.0)
n (%) or median (interquartile range)

[Insert Table 1 here]

Figure 2 shows whether patients were liberated from MV and discharge status until day 180. The stratified results of liberation and discharge status on day 180 are summarized in Table 2.

Table 2

Liberation and Discharge status on Day 180 by care level before intubation and age categories
	All		Care level < 3		Care level ≥ 3
	(n = 272)		(n = 235)		(n = 37)
	n	(%)	n	(%)	n	(%)	p-value
Liberation	200	(73.5)	173	(73.6)	27	(73.0)	0.93
Discharge status
Discharge	116	(42.6)	106	(45.1)	10	(27.0)	0.039
Hospitalized	54	(19.9)	41	(17.4)	13	(35.1)	0.012
Deceased	102	(37.5)	88	(37.4)	14	(37.8)	0.96

	Age 65–74		Age 75–84		Age > 85
	(n = 87)		(n = 123)		(n = 62 )
	n	(%)	n	(%)	n	(%)	p-value
Liberation	59	(67.8)	98	(79.7)	43	(69.4)	0.11
Discharge status
Discharge	40	(46.0)	55	(44.7)	21	(33.9)	0.28
Hospitalized	17	(19.5)	26	(21.1)	11	(17.7)	0.86
Deceased	30	(34.5)	42	(34.1)	30	(48.4)	0.13
p-value: the results of Chi-square test or Fisher’s exact test

Liberation status

Among all patients, 73.5% achieved liberation from MV until day 180 and 26.5% did not. The proportion of liberation were 73.6% and 73.0% for CL < 3 and CL ≥ 3, respectively. The proportion of liberation were 67.8%, 79.7%, and 69.4% for the age categories 65–74, 75–84, and ≥ 85 years, respectively. No significant difference between proportion of liberation was found for CL or age categories.

Discharge status

Among all patients, 42.6% were discharged, 19.9% remained hospitalized, and 37.5% died in hospital until day 180. No significant difference between 180-day mortality rate were found for CL or age categories. The proportion of hospitalized patients were 17.4% and 35.1% for CL < 3 and CL ≥ 3, respectively. The proportion of hospitalized patients were 19.5%, 21.1%, and 17.7% for the age categories 65–74, 75–84, and ≥ 85 years, respectively. The proportion of hospitalized patients among CLs were significantly different (p = 0.012).

Time-course of liberation and discharge

Figure 3 shows the number of days that elapsed until liberation or death until day 90.

The proportion of liberation and death both increased steeply until about day 14, after which the increase became more gradual. Overall, 32.7% of patients were still hospitalized on MV on day 14. The same trend was seen in those requiring CL < 3 and in every age category. Among patients with CL ≥ 3, the increase rate seemed to be more gradual, although the proportion of liberation until day 180 was similar to that in other subgroups.

Although most patients were either liberated or died early after implementation of IMV, a significant number of patients required prolonged hospitalization: 19.9% of all patients were still hospitalized on day 180. Longer hospitalization was required in cases of CL ≥ 3.

Main findings

This study found that many older patients could be successfully liberated from MV, with approximately 40% able to discharge until day 180. However, patients with higher care levels needed to be on MV longer and had longer hospitalization.

IMV for older patients

The results of this study provide insights for clinical decision making regarding the initiation of IMV in older patients in Japan. It is commonly observed that physicians in Japan are reluctant to initiate IMV due to concerns about the difficulty of liberation and poor prognosis [27, 28]. However, our findings indicate that a substantial proportion of older patients can indeed be liberated from IMV, challenging the previously held assumptions due to a lack of evidence.

Nevertheless, it is crucial to carefully consider the post-liberation prognosis. Our findings showed that many patients required prolonged hospitalization, and the in-hospital mortality rate remained high despite the high liberation rate. These results highlight the importance of not only discussing the potential for liberation but also communicating the risks associated with prolonged MV and hospitalization which indicate potential declines in physical function with patients and their families.

Considering these findings, decision-making regarding the initiation of IMV in elderly patients should be balanced. While excessive caution may be unwarranted, it is equally important to have thorough discussions about the potential risks and outcomes of IMV with patients and their families.

Liberation

This study revealed that most older patients who experienced IMV achieved liberation from IMV. In Japanese medical practice, physicians sometimes refrain from initiating IMV due to the risk of not being able to liberate the patient due to age and CL, given that palliative withdrawal of IMV is discouraged in Japan [1]. However, there is also risk that patients and their families may feel forced to abandon IMV against their wishes if physicians over-emphasize the risk of MV dependency [29]. The results of this study raise concerns that excessive restraint might occur in such a situation.

Discharge

Although the proportion of liberation was high, 33.7% of patients died in hospital until day 180 even after excluding patients who died within 3 days after intubation. If patients who died within 3 days were included, 70.4% of patients died in hospital until day 180. Compared to a previous study from the United States, which reported in-hospital mortality among patients who were intubated in the Emergency Department and were aged ≥ 65 years as 33%, without excluding acute stage death [10], the in-hospital mortality in our study was exceedingly high. This might suggest that Japanese physicians tend to intubate more aggressively in older patients even though their prognosis might be poor.

In addition, the care need level may worsen after MV [5] and a risk of physical function decline is associated with ICU management [6]. Even if patients achieved liberation, certain patients required prolonged hospitalization and/or died in hospital. The patients with CL ≥ 3 tended to require more days to be weaned from MV and longer hospitalization; therefore, the risk of adverse effects, such as worsening of CL or physical function decline, might be higher in this category of patients than in others.

Limitations of the study

This study had some limitations. First, this study included more patients with a higher potential for liberation because, among those requiring IMV, only patients who actually underwent IMV were included in this study. The proportion of liberation might be higher and the in-hospital mortality rate might have been lower if all patients who required IMV actually received this support.

Second, among those who had not received long-term care certification, some individuals may have high care needs. However, since many individuals with CL ≥ 3 tended to have the degree of bedriddenness and the level of independence of older individuals with dementia, we assumed that a large proportion of those not certified would correspond to CL < 3.

Third, with the limited information from receipt data, we could not assess or stratify the indication of IMV and severity of patients’ condition, which have a significant impact on liberation.

Further large-scale research is desired to assess the association between age or CL and prognosis of IMV patients, with more detailed information on the indication of IMV, as well as the severity of the condition, which are not provided from receipt data.

This study shows that many older patients can be successfully liberated from IMV. For patients with higher care needs, the duration of IMV is longer, and the proportion of prolonged hospitalization is higher. It might be important not only to focus on the potential difficulty of liberation, but also to convey the risks of undesired outcomes and of physical function decline due to the duration of MV appropriately when conducting discussions with patients and their family members.

CI, confidence interval; CL, care level; ICU, intensive care unit; IMV, invasive mechanical ventilation; IQR, interquartile range; MV, mechanical ventilation.

Ethics approval and consent to participate: The study was conducted in accordance with the tenets of the Declaration of Helsinki. All methods were carried out in accordance with relevant guidelines and regulations. All data obtained from Tsukuba City were anonymized. The study protocol was approved by the institutional review board of the University of Tsukuba (approval number: 1445-13, date of approval: 21 September 2023). Data were anonymized prior to being provided to the researchers; thus, the need for obtaining informed consent was waived.

Consent for publication: Not applicable.

Availability of data and materials: The data supporting the findings of this study are available from Tsukuba City, but restrictions apply to the availability of these data, which were used under license for the current study, and thus are not publicly available. Data are, however, available from the authors upon reasonable request and with permission of the Tsukuba City.

Competing interests: The authors declare no conflict of interest.

Funding: None.

Authors’ contributions: SA conceived the study. SA analyzed the data and IR checked the analyses. SA wrote the first draft of this manuscript. IR, IM, KN, IY, and TN critically revised the manuscript. All authors read and approved the final version of the manuscript.

Acknowledgements: We are extremely grateful to the members of Tamiya Laboratory, University of Tsukuba, for their advice.

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No competing interests reported.

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Liberation and Discharge Status of Older Patients After Invasive Mechanical Ventilation: A Retrospective cohort study

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Abstract

Background

Methods

Results

Conclusions

Figures

Background

Methods

Data source

Participants

Extracted data items

Analyses

Results

Liberation status

Discharge status

Time-course of liberation and discharge

Discussion

Main findings

IMV for older patients

Liberation

Discharge

Limitations of the study

Conclusions

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1