The VapCare system comes with two major components. Figure 1 is a schematic diagram of the device setup. The first component is an intelligent electromechanical system that controls suctioning based upon a build-up inflow sensor input. This device also has multiple ports to convert suction pressure from a wall-mounted or portable suction unit into modulated suctioning as required in the oral, oropharyngeal, and subglottic regions. The sensing unit uses flow detection and assessment to regulate the suction duration and when to cease suctioning. This device can also detect port blockages and has been designed to minimize suction duration and pressure applied to the patient’s airway compared to other continuous closed-loop systems. The user can set suction frequency and pressure.
The second component is the disposable VapLumen that slides over the top of an endotracheal tube (ETT) and extends into the oropharynx. The VapLumen has multiple suction ports and a single port for sprinkling an oral lavage solution. The disposable VapLumen must be connected to the first component to perform automated suctioning and oral lavage. The VapLumen is equipped with a bite blocker and a fastener to ensure that the ETT is held in place safely. The VapLumen also has soft-tipped tubes made with biocompatible materials that can be adjusted to each patient’s requirements to optimize positioning in the oropharyngeal region.
All respiratory therapists, nurses, and doctors involved in the care of patients were trained on VapCare prior to the start of the study. Prior to being recruited to the study, patients were screened by the physician to ensure that they fit the inclusion and exclusion criteria. Refer to Table 1 for the inclusion and exclusion criteria.
Table 1: Inclusion and Exclusion Criteria
Patients must be over 18 years of age.
Patient must be intubated with above the cuff suction enabled endotracheal tube.
Health care worker is able to place the suction lumen appropriately and fix it in position.
Patient or a legal representative of the patient must be able to give written consent for the study.
Patient is expected to be on a ventilator for >48 hours.
Patient is COVID positive.
Patient has been intubated for >24 hours before recruitment to study.
Patient with past history of pulmonary tuberculosis.
Patient with HIV infection.
Patient with past history of ventricular fibrillation.
Patient with history of cardiac arrest.
Patient with history of bleeding disorders.
Patient is pregnant.
Patient with severe head/neck and facial injuries.
Patient with tracheostomy on admission.
Patient enrolled in another study.
Patient has already participated in the study.
All subjects in this study were followed from the date they were enrolled until they were discharged. This study took place between August 2021 and February 2022. Case report forms were filled out by nurses and doctors involved in the care of these patients. Patients in the Cx received oral care and manual suctioning, which is the current standard of care. Patients in the Tx received VapCare, which provides pressure-controlled automated suctioning and oral lavage.
To assess the safety of VapCare and the VapLumen, the physician performed a laryngoscopy prior to the placement of the lumen, and follow-up laryngoscopies were performed daily to ensure there was no tissue damage. Visual assessments were also performed by healthcare workers every 2 hours to detect the incidence of any adverse events due to the device.
Twelve patients that met the inclusion criteria were admitted during the study. Six were assigned to the Tx, and six were assigned to the Cx. The Tx received automated suctioning and oral lavage along with daily teeth brushing. The Cx received the current standard of care, including manual suctioning as needed, teeth brushing once a day, and manual oral swabbing with chlorhexidine every four to six hours. The VapCare device was used as intended and according to the manufacturer's instructions. Data regarding the incidence of ventilator-associated condition (VAC), infection-related ventilator-associated complication (iVAC), and possible ventilator-associated pneumonia (pVAP) was collected. Furthermore, data regarding the average cost of antibiotics (ABX) and the amount of secretions collected was tracked for comparison.
This single-center, prospective, randomized, open blinded end-point (PROBE) study was conducted to assess the performance and safety of the automated device, VapCare, (along with VapLumen) in delivering oral care, secretion clearance, and in reducing the incidence of VAP compared to manual suctioning. The average cost of ABX and the average amount of secretions removed were also collected from the treatment (Tx) and control group (Cx) to analyze if there is a cost reduction and if automated suctioning is superior to the manual process in clearing secretions.
A tertiary care facility that is National Accreditation Board for Hospitals accredited in Bangalore, India.
We randomized patients through a central office using variable permuted block sizes. We randomized patients through interactive voice-based randomization software.
Allocation Ratio and Concealment
We allocated the patients in a 1:1 ratio, and the allocation sequence was concealed at the central office handling the randomization sequence.
This was an open label trial and blinding was not applicable to the investigators or the patients.