Two-center study of Volume-OXygenation index in predicting the efficacy of early non-invasive ventilation in patients with hypoxemic Respiratory failure

doi:10.21203/rs.3.rs-3791407/v1

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Two-center study of Volume-OXygenation index in predicting the efficacy of early non-invasive ventilation in patients with hypoxemic Respiratory failure

https://doi.org/10.21203/rs.3.rs-3791407/v1

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Background

The Volume OXygeneration (VOX) index was initially designed to predict treatment failure of high-flow nasal cannula therapy. However, its predictive power for treatment failure in patients receiving non-invasive ventilation (NIV) remains uncertain.

Methods

This retrospective study was conducted across two centers from September 2017 to September 2021. Patients who underwent early NIV treatment were grouped based on their 2-hour NIV VOX Youden index. The low-risk group consisted of patients with a VOX index > 20.45 (n = 188), while the high-risk group included those with a VOX index ≤ 20.45 (n = 200). Baseline data and arterial blood gas values were collected at 2, 12, and 24 hours after NIV initiation.

Results

Compared to the low-risk group, the high-risk group exhibited higher SOFA scores, respiratory rates, and heart rates, along with a lower oxygenation index (P/F) (all P < 0.05). Following NIV treatment, the low-risk group showed a more significant increase in P/F values at 2 hours, 12 hours, and 24 hours after NIV initiation. Moreover, the low-risk group had a lower intubation rate (3.19% vs. 60%, P < 0.05) and mortality rate (4.79% vs. 17.5%, P < 0.05). At 2 hours of NIV, the area under the receiver operating characteristic curve for predicting NIV failure using the VOX index was 0.843 (95% CI 0.805–0.882). Using a VOX index threshold of 20.45 to predict NIV failure, the sensitivity was 69.1%, and the specificity was 94.4%. Furthermore, a VOX index ≤ 20.45 was identified as an independent risk factor for tracheal intubation and death.

Conclusions

In early NIV treatment for hypoxemic acute respiratory failure, the VOX index obtained after 2 hours of NIV demonstrates a strong predictive power for NIV failure. Patients with a VOX index > 20.45 have a low probability of NIV failure, suggesting that it can be used as an evaluation index to assess the efficacy of NIV.

Volume OXygeneration index

Acute respiratory failure

Hypoxemia

Noninvasive ventilation

Endotracheal intubation

Non-invasive ventilation (NIV) has proved to be an effective treatment for respiratory failure, demonstrating a significant reduction in mortality, from 20.6–14.2% [1]. Consequently, the utilization of NIV has been steadily rising over the years [2, 3]. Despite the availability of numerous NIV guidelines [4–7], the failure rate of NIV remains substantial, reaching up to 50% [8]. Notably, patients experiencing NIV failure face a staggering 96-fold higher risk of in-hospital mortality compared to successful patients [9], with actual mortality rates soaring to 72.7% in some cases [10]. Additionally, patients transitionally to invasive mechanical ventilation after NIV failure exhibit significantly elevated mortality rates [11]. The delayed intubation may exacerbate the condition, further leading to increased mortality rates [12, 13].

Currently, the literature suggests two main methods for determining the effectiveness of NIV: the single-variable method and the HACOR score. The reported evaluation of the univariate method is only moderately effective [14–17]. The HACOR score, on the other hand, incorporates five indicators (heart rate, respiratory rate, state of consciousness, pH, and oxygenation index - P/F ratio) to establish an NIV effectiveness evaluation scale [18, 19]. However, the HACOR score may not fully capture the pathological changes observed in patients with hypoxemic acute respiratory failure (ARF), such as the driving effect of high respiration [20]. Particularly, studies have shown that high tidal volume, rather than respiratory rate alone, is independently associated with NIV failure [21, 22]. Addressing the challenge of evaluating respiratory drive changes in patients with hypoxemic ARF is crucial to improve NIV treatment outcomes, although the latest guidelines on the use of NIV during ARF have no recommendations [23].

The Volume OXygeneration (VOX) index, initially developed to predict treatment failure of high-flow nasal cannula (HFNC) therapy, has demonstrated the ability to estimate early increases in respiratory drive. Within the first 2 hours, the VOX index exhibits a discriminative potential of 0.88 (95% CI 0.79–0.97) in predicting HFNC failure [24]. Based on this premise, we hypothesize that the VOX index may also serve as a predictive tool for NIV treatment failure and, therefore, undertake retrospective studies to validate its utility.

2.1. Subjects

This retrospective study focused on patients with hypoxemic ARF admitted to the Department of Respiratory and Critical Care Medicine of Sichuan Provincial People's Hospital and the Intensive Care Unit (ICU) of Dazhou Central Hospital between September 2017 and September 2021. Out of 400 patients initially selected for early NIV treatment, 12 patients were excluded due to NIV intolerance and data loss, resulting in a total of 388 patients included in the study. As the retrospective design, the need for informed consent was waived and approved by the Ethics Committee of Dazhou Central Hospital (No. 2023060).

The treatment plans for patients were identical, following NIV guidelines. Patients unable to tolerate NIV were treated with high flow nasal cannula (HFNC) and excluded from the study. Successful NIV patients were transitional to HFNC treatment, while NIV failures were intubated with invasive mechanical ventilation, analgesia, and sedation [25]. The concept of NIV successfully de-escalation was the case that patients with NIV can be downgraded to HFNC, maintain stable vital signs and arterial blood gas results, and persist for more than one day. Those who refused tracheal intubation received palliative NIV. The NIV use and management were built on NIV guidelines, concerning relevant research reports [24, 26]. Non-invasive pressure support ventilation (PSV) mode was enabled, with a target tidal volume greater than 300ml (or greater than 5ml/kg ideal body weight), and the RR set below 25 times/min. Improvement in respiratory status and arterial blood gas results after NIV were identified as NIV success. Additional treatment measures included expectorant therapy, anti-asthmatic medication, anti-infection treatment, bronchoscopy, nutritional support, early rehabilitation, and intensive care. The SpO₂, FiO₂, and VT (average of three consecutive tidal volume monitoring values/ideal body weight) were recorded after 2 hours, and the VOX index was computed using the formula: VOX index = SpO₂ / (FiO₂ * VT). The baseline data such as basic information, underlying disease, acute physiological and chronic health score (APACHE II), Glasgow coma score (GCS), sequential organ failure score (SOFA), and the vital signs and laboratory test results before using non-invasive ventilation were collected. The arterial blood gas values and NIV results at 2 hours, 12 hours, and 24 hours after initiation were collected for all patients. NIV outcomes, intubation status, NIV duration, hospital stay, and mortality rates were registered.

2.2. Inclusion and Exclusion Criteria [18, 19]

Inclusion criteria:

Age not less than 16 years old.

ARF defined by PaO₂ / FiO₂ < 300 mmHg and PaCO₂ ༜ 50 mmHg.

RR > 25 beats/min or increased respiratory work.

Initiation of NIV treatment after the occurrence of ARF.

NIV treatment duration of at least 2 hours.

Exclusion criteria:

Age less than 16 years old.

Patients who meet tracheal intubation criteria but refuse to undergo tracheal intubation and opt for NIV as a replacement therapy.

Patients who received NIV after accidental extubation.

Patients who underwent preventive NIV following scheduled extubation.

Hypoxemia due to heart failure.

2.3. Statistical Analyses

Statistical analyses were carried out using SPSS 22.0 statistical software. Measurement data were evaluated using t-tests or rank sum tests and presented as means ± standard deviations. Categorical variables were analyzed using chi-square tests. Multivariate logistic regression was used to identify independent risk factors associated with tracheal intubation and death. A significance level of P < 0.05 was considered statistically significant. The receiver operating characteristic of tracheal intubation with 2-hour NIV VOX Index, the Youden index was 20.45, the VOX index ≤ 20.45 was high risk, and the VOX index > 20.45 was low risk.

3.1. Baseline Data of Enrolled Patients

At 2 hours of NIV, the area under the receiver operating characteristic curve for predicting NIV failure evaluated by the VOX index was 0.843 (95% CI 0.805–0.882) (Fig. 1). Utilizing a VOX index threshold of 20.45 to predict NIV failure, the sensitivity was 69.1%, and the specificity was 94.4%. Based on the 2-hour NIV VOX Youden index, patients were categorized into the low-risk group (n = 188) with VOX index > 20.45 and the high-risk group (n = 200) with VOX index ≤ 20.45 (Fig. 2). Upon enrollment, the high-risk group exhibited higher SOFA scores, RR, and HR, whereas the low-risk group had higher P/F ratios (P < 0.05). No statistically significant differences were found in other baseline data (Table 1).

Table 1

Baseline data
	Total (n = 388)	Low risk group (n = 188)	High risk group (n = 200)	Difference (95% CI)	P value
Age, mean ± sd, years	62 ± 16.8	64 ± 16.9	61 ± 16.6	3.1(-0.29,6.42)	0.073
Female, n (%)	135(34.79)	71(37.77)	64(32)	-	0.233
Male, n (%)	253(65.21)	117(62.23)	136(68)	-	0.233
Underlying disease
Hypertension, n (%)	158(40.72)	84(44.68)	74(37)	-	0.124
Diabetes, n (%)	75(19.33)	40(21.28)	35(17.5)	-	0.346
Coronary heart disease, n (%)	42(10.82)	23(12.23)	19(9.5)	-	0.386
AIDS, n (%)	7(1.8)	4(2.13)	3(1.5)	-	0.642
Malignancy, n (%)	51(13.14)	24(12.77)	27(13.5)	-	0.831
Chronic renal insufficiency, n (%)	59(15.21)	33(17.55)	26(13)	-	0.212
Chronic hepatic insufficiency, n (%)	20(5.15)	8(4.26)	12(6)	-	0.437
Chronic cardiac insufficiency, n (%)	139(35.82)	72(38.3)	67(33.5)	-	0.325
Diagnosis
Pneumonia, n (%)	348(90.46)	169(89.9)	182(91)	-	0.711
Sepsis, n (%)	31(7.99)	14(7.45)	17(8.5)	-	0.702
Pancreatitis, n (%)	6(1.55)	5(2.65)	1(0.5)	-	0.085
The time of admission
APACHE II, mean ± sd, score	17 ± 6.6	17 ± 6.3	18 ± 6.9	-1.5(-2.83,-0.21)	0.735
GCS, mean ± sd, score	14 ± 2	14 ± 1.7	14 ± 2.2	0( -0.39,0.38)	0.970
SOFA, mean ± sd, score	6 ± 2.6	5 ± 2.3	6 ± 2.8	-0.8(-1.35,-0.34)	0.001
Before NIV
Body temperature, mean ± sd, ℃	37.1 ± 0.85	37.1 ± 0.81	37.2 ± 0.88	-0.1( -0.29,0.05)	0.167
Respiratory rate, mean ± sd, breaths/min	29 ± 7.1	28 ± 5.6	30 ± 8.1	-2.3( -3.67,-0.86)	0.002
Heart rate, mean ± sd, beats/min	109 ± 23.5	106 ± 22.8	112 ± 24	-5.2(-9.91,-0.56)	0.028
SBP, mean ± sd, mm Hg	131 ± 21.5	130 ± 24	132 ± 26.8	-1.6(-6.72,3.48)	0.533
DBP, mean ± sd, mm Hg	78 ± 15.9	78 ± 15.2	78 ± 16.5	-0.5(-3.69,2.68)	0.755
WBC, mean ± sd, 10⁹/L	11.7 ± 7.96	11.4 ± 6.23	11.9 ± 9.31	-0.5(-2.06,1.31)	0.569
PLT, mean ± sd, 10⁹/L	174.8 ± 108.62	187.5 ± 110.49	162.91 ± 105.72	24.7(3.11,46.38)	0.187
Hb, mean ± sd, g/L	110.7 ± 31.35	107.3 ± 28.04	113.8 ± 33.94	-6.5(-12.72,-0.21)	0.132
pH, mean ± sd	7.43 ± 0.09	7.43 ± 0.08	7.43 ± 0.1	0(-0.02,0.02)	0.753
PaCO₂, mean ± sd, mm Hg	33.9 ± 7.52	34.7 ± 7.3	33 ± 7.64	1.7(0.18,3.18)	0.455
P/F, mean ± sd, mm Hg	129.9 ± 38.32	139 ± 37.78	121.3 ± 36.92	17.7(10.19,25.14)	0.000
CI, confidence interval; AIDS, Acquired Immune Deficiency Syndrome; APACHE II, Acute Physiology and Chronic Health Evaluation II; GCS, Glasgow Coma Scale; SOFA, Sequential Organ Failure Assessment; SBP, systolic blood pressure; DBP, Diastolic blood pressure; WBC, white blood cell count; PLT, Platelet count; Hb, hemoglobin; PaCO₂, Partial pressure of carbon dioxide; P/F, arterial blood oxygen partial pressure/inhaled oxygen concentration.

3.2. NIV Status and Arterial Blood Gas Between the Two Groups from Initiation to 24 Hours of NIV

After 2 hours of NIV, both groups showed no difference in NIV success rate and intubation rate after NIV failure. However, after 12 hours of NIV, the low-risk group exhibited a higher NIV success rate (3.72% vs. 0%, P < 0.05) and a lower NIV intubation failure rate (2.13% vs. 17%, P < 0.05). Similarly, after 24 hours of NIV, the low-risk group demonstrated a higher NIV success rate (21.28% vs. 0%, P < 0.05) and a lower NIV intubation failure rate (2.13% vs. 26.5%, P < 0.05).

Compared with baseline values, both groups exhibited no statistically significant difference in pH and PaCO₂ after NIV treatment. However, there was a major increase in the P/F ratio after treatment in both groups (P < 0.05). Furthermore, the low-risk group showed a more significant increase in P/F ratio at 2 hours, 12 hours, and 24 hours of NIV (P < 0.05), while no statistically significant differences were observed in pH and PaCO₂ between the two groups (Table 2).

Table 2

The status of NIV and arterial blood gas between two groups from initiation to 24 hours of NIV
	Low risk group(n = 188)	High risk group (n = 200)	Difference (95% CI)	P value
Before NIV	(n = 188)	(n = 200)
pH, mean ± sd	7.43 ± 0.08	7.43 ± 0.1	0(-0.02,0.02)	0.753
PaCO₂, mean ± sd, mm Hg	34.7 ± 7.3	33 ± 7.64	1.7(0.18,3.18)	0.455
P/F, mean ± sd, mm Hg	139 ± 37.78	121.3 ± 36.92	17.7(10.19,25.14)	0.000
2 hours of NIV	(n = 188)	(n = 200)
Successfully de-escalated, n (%)	0(0)	0(0)	-	-
Intubation, n (%)	0(0)	0(0)	-	-
Continuing NIV, n (%)	188(100)	200(100)	-	-
pH, mean ± sd	7.44 ± 0.06	7.43 ± 0.08	0(-0.00,0.02)	0.157
PaCO₂, mean ± sd, mm Hg	35.1 ± 7.35	33.5 ± 7.95	1.6(0.08,3.14)	0.621
P/F, mean ± sd, mm Hg	182.5 ± 66.14^*	144.1 ± 63.6^*	38.4(25.46,51.36)	0.000
12 hours of NIV	(n = 177)	(n = 166)
Successfully de-escalated, n (%)	7(3.72)	0(0)	-	0.006
Intubation, n (%)	4(2.13)	34(17)	-	0.000
Continuing NIV, n (%)	177(94.15)	166(83)	-	0.001
pH, mean ± sd	7.45 ± 0.05	7.45 ± 0.07	0(-0.04,0.13)	0.289
PaCO₂, mean ± sd, mm Hg	35.5 ± 6.57	33.9 ± 8.09	1.8(0.19,3.4)	0.155
P/F, mean ± sd, mm Hg	205.5 ± 75.25^*	149.9 ± 69.61^*	55(39.57,70.47)	0.000
24 hours of NIV	(n = 144)	(n = 147)
Successfully de-escalated, n (%)	40(21.28)	0(0)	-	0.000
Intubation, n (%)	4(2.13)	53(26.5)	-	0.000
Continuing NIV, n (%)	144(76.6)	147(73.5)	-	0.482
pH, mean ± sd	7.46 ± 0.05	7.45 ± 0.06	0(-0.01,0.02)	0.437
PaCO₂, mean ± sd, mm Hg	35.6 ± 6.9	34.2 ± 7.24	1.5(-0.17,3.09)	0.080
P/F, mean ± sd, mm Hg	202.8 ± 79.53^*	142 ± 62.54^*	60.8(44.29,77.27)	0.000
CI, confidence interval; NIV, Non-invasive ventilation; PaCO₂, Partial pressure of carbon dioxide; P/F, arterial blood oxygen partial pressure/inhaled oxygen concentration.
* P < 0.05 is the comparison before and after NIV treatment.

3.3. Outcomes

After treatment, the low-risk group demonstrated a higher NIV success rate (84.04% vs. 24.5%, P < 0.05) and a longer hospital stay [(17.2 ± 12.41) vs. (14.5 ± 12.5) days, P < 0.05] compared to the high-risk group. Additionally, the low-risk group had a lower tracheal intubation rate (3.19% vs. 60%, P < 0.05) and mortality rate (4.79% vs. 17.5%, P < 0.05) than the high-risk group. No statistically significant differences were found between the two groups regarding the number of patients discharged with NIV from the hospital, the number of family-administered NIV cases, and the duration of NIV treatment (Table 3).

Table 3

Outcomes
	Total (n = 388)	Low risk group(n = 188)	High risk group (n = 200)	Difference (95% CI)	P value
NIV outcomes
NIV successfully de-escalated, n (%)	207(53.35)	158(84.04)	49(24.5)	-	0.000
Endotracheal intubation, n (%)	126(32.47)	6(3.19)	120(60)	-	0.000
Discharge with NIV, n (%)	55(14.18)	24(11.67)	31(15.5)	-	0.440
NIV time, mean ± sd, d	4.2 ± 4.66	4.2 ± 4.48	4.2 ± 4.85	-0.1(-0.98,0.89)	0.125
Hospital stay, mean ± sd, d	15.8 ± 12.51	17.2 ± 12.41	14.5 ± 12.5	2.9(0.46, 5.37)	0.002
Mortality, n (%)	44(11.34)	9(4.79)	35(17.5)	-	0.000
CI, confidence interval; NIV, Non-invasive ventilation.

3.4. Independent Risk Factors Associated with Tracheal Intubation and Death

Logistic regression analysis of independent risk factors for tracheal intubation showed that a 2-hour NIV VOX index ≤ 20.45 and APACHE II score were risk factors, while systolic blood pressure and chronic cardiac insufficiency were protective factors against tracheal intubation. Furthermore, multifaceted logistic regression analysis of independent risk factors for death identified a 2-hour NIV VOX index ≤ 20.45 and age as risk factors (Table 4).

Table 4

Independent risk factors associated with Tracheal intubation and death identified by multivariate logistic regression analysis
Risk factors	OR (95% CI)	P value
Endotracheal intubation
2-hour NIV VOX index ≤ 20.45	51.942 (21.132, 127.672)	0.000
APACHE II, score	1.068 (1.021, 1.117)	0.004
DBP, mm Hg	0.977 (0.959, 0.995)	0.011
Chronic cardiac insufficiency	0.429 (0.233, 0.790)	0.007
Death
2-hour NIV VOX index ≤ 20.45	4.815 (2.090, 11.091)	0.000
Age, years	1.039 (1.012, 1.066)	0.004
OR, odds ratio; CI, confidence interval; NIV, Non-invasive ventilation; VOX, Volume-OXygenation; APACHE II, Acute Physiology and Chronic Health Evaluation II; DBP, Diastolic blood pressure.

Volume OXygeneration (VOX) index, a new early predictor of high-flow nasal cannula (HFNC) failure in ARF patients, which estimates early increases in respiratory drive. The VOX index is independently related to a lower risk of HFNC failure within 2 to 6 hours of treatment [24]. In current study, we validated the efficacy of VOX index in prediction of NIV failure. The AUC was 0.843, showing a good predictive power of NIV failure.

The results of the retrospective study reported that the low-risk group, with a VOX index > 20.45, had a significantly higher success rate of NIV and lower rates of tracheal intubation and mortality compared to the high-risk group. This finding aligns with previous research, demonstrating the effectiveness of the VOX index in predicting NIV failure in patients with hypoxemic ARF. High respiratory drive in patients with hypoxia can lead to increased tidal volume, contributing to ventilator-induced lung injury [7, 27, 28], and higher tidal volume, rather than respiratory rate alone, has been linked to NIV failure in these patients [21, 22].

Meanwhile, the study outcomes found that the average NIV time between the two groups was roughly equal, because the low-risk group had a higher success rate of NIV and a larger number of patients as early NIV evacuees, while the high-risk group had a higher failure rate of early NIV. The hospitalization time of the low-risk group patients was higher than that of the high-risk group, due to the low-risk group having a higher success rate of NIV and a larger number of patients receiving late hospitalization treatment. The study outcomes also found that the high-risk group had a high failure rate of NIV, a high rate of Tracheal intubation, and a high mortality rate, which was consistent with pertinent research reports. NIV used in patients with hypoxemic ARF can improve oxygenation, promote ventilation, reduce respiratory work and dyspnea, avoid intubation, and reduce complications related to invasive mechanical ventilation [29], but patients with NIV failure may have a delay in invasive mechanical ventilation of Tracheal intubation, leading to an increase in mortality [30–32].

The study also found that the 2-hour VOX index ≤ 20.45 was a risk factor for tracheal intubation and death. This confirms the value of NIV as a therapeutic option for patients with acute left heart failure [7, 8], and the 2-hour VOX index ≤ 20.45 can be used as a predictor of tracheal intubation and death risk.

However, the study has some limitations. It is a retrospective study, and NIV settings were not entirely standardized when obtaining VOX index results. Additionally, the total sample size of the study centers was relatively small, and large-scale, multi-center randomized controlled trials were absent.

In conclusion, the VOX index can serve as an effective evaluation index to predict early NIV efficacy in patients with hypoxemic ARF. A VOX index > 20.45 after 2 hours of NIV treatment can better predict improvements in hypoxia and NIV outcomes, guide early tracheal intubation in cases of NIV failure, and have a certain predictive effect on patient outcomes.

ARF: acute respiratory failure; NIV: Non-invasive ventilation; VOX: Volume OXygeneration; HACOR: Heart rate, acidosis, consciousness, oxygenation, and respiratory rate; RR: respiratory rate; HR: heart rate; P/F: arterial blood oxygen partial pressure/inhaled oxygen concentration; HFNC: high flow nasal catheter; OR: Odds ratio; CI: Confidence interval; ICU: Intensive care unit; AIDS: Acquired Immune Deficiency Syndrome; APACHE II, Acute Physiology and Chronic Health Evaluation II; GCS, Glasgow Coma Scale; SOFA, Sequential Organ Failure Assessment; SBP, systolic blood pressure; DBP, Diastolic blood pressure; WBC, white blood cell count; PLT, Platelet count; Hb, hemoglobin; PaCO₂, Partial pressure of carbon dioxide; AUC: Area under the receiver operating characteristic curve.

Acknowledgments

Thank Dazhou Central Hospital for providing research projected to support, Sichuan Provincial People's Hospital and Dazhou Central Hospital for providing medical records, Lijuan Chen, Liu Hui, Hui Ran, Lili Chen, etc. for collecting data, and Jun Duan, Xiangde Zheng, etc. for their guidance of the research.

Author contributions

Xiaoyi Liu conceived this study and is in charge of its completeness. Lijuan Chen, Hui Liu, Hui Ran, Lili Chen, and Xiangde Zheng were involved in research design, research management, data collection, data analysis, and manuscript preparation. Jun Duan was involved in research design, data analysis, and manuscript preparation. All authors have been instrumental in the content of the manuscript and approved the manuscript version.

Funding

This research received the support of Dazhou Central Hospital (2022YJ13).

Availability of data and materials

The datasets used and/or analyzed in the current study are obtained from the corresponding author upon reasonable request.

Ethical approval and consent to participate

The study was endorsed by the Ethics Committee of Dazhou Central Hospital (No. 2023060), and the treatment process followed the diagnostic and therapeutic norms. As the retrospective design, the informed consent was waived.

Consent for publication

Not applicable.

Competing interests

We declare that we have no competing interests.

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No competing interests reported.

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Two-center study of Volume-OXygenation index in predicting the efficacy of early non-invasive ventilation in patients with hypoxemic Respiratory failure

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Abstract

Background

Methods

Results

Conclusions

Figures

1. Introduction

2. Materials and Methods

2.1. Subjects

2.2. Inclusion and Exclusion Criteria [18, 19]

2.3. Statistical Analyses

3. Results

3.1. Baseline Data of Enrolled Patients

3.3. Outcomes

3.4. Independent Risk Factors Associated with Tracheal Intubation and Death

4. Discussion

5. Conclusions

Abbreviations

Declarations

References

Additional Declarations

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