Clinical trial NCT04873336: Closed Loop Ventilation in Patients With COVID-19
Official title: Tidal Volumes Are Generated Automatically With Closed Loop Ventilation (INTELLIVENT ASV) is Safe in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
ARDS
Keywords: Mechanical ventilation
Adaptive support ventilation
Transpulnonary pressure
Safety
Lead sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with COVID-19 who received invasive mechanical ventilation due to respiratory failure in intensive care unit

Brief summary: Transpulmonary pressure may be higher in ARDS patients due to decreased respiratory system compliance. The hypothesis is that tidal volumes which are generated by Intellivent- Adaptive support ventilation (ASV) are safe range by transpulmonary pressure.

Detailed description: Patients will be enrolled in the first 24 hours of admission to the intensive care unit. APACHE-2 and SAPS-2 scores will be noted 24 hours after admission. COVID-19 pneumonia will be confirmed according to World Health Organization (WHO) interim guidance. Level of sedation will be monitored with Ramsey Sedation Scale.

An esophageal balloon will be inserted in order to measure transpulmonary pressure(Ptp). The proper localization will be estimated according to ear-nose-xiphoid length. Localization of the balloon will be confirmed with the Baydur maneuver. Mojoli methods will be used to optimize the balloon filling volume.

All patients will be mechanically ventilated under Intellivent-ASV mode. Initial settings will based on predicted body weight. 45 cmH2O will be determined as target end-tidal carbondiokside (ETCO2) but permissive hypercapnia will be allowed if necessary, to maintain lung protective ventilation. Safe pH value will be determined 7.25 independent from ETCO2 levels in patients who will be applied lung protective ventilation. FiO2 and PEEP will be set to maintain an SpO2 of 88-92%.

Ptpinsp will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during inspiratory pause maneuver. Targeted inspiratory transpulmonary pressure (Ptpinsp) was determined to be below 20 cmH2O. If Ptpinsp exceeds 20 cmH2O, minute-volume (MinVol) will be decreased by 10%. Minvol will be reduced below 100% if necessary, to achieve the target. Expiratory transpulmonary pressure (Ptpexp) will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during expiratory pause maneuver. Targeted Ptpexp was determined from 0 to 3 cmH2O. If Ptpexp is below 0 cmH2O, PEEP will be increased until Ptpexp is positive. If Ptpexp exceed 3 mH2O, PEEP will be decreased until Ptpexp is below 3 mH2O. Transpulmonary pressure will be recorded at the beginning after that at least twice daily morning and evening visits. All measurement will be made in passive condition. Transpulmonary pressure measurement will continue until the patient is awake.

Eligibility criteria: Inclusion Criteria:

* COVID-19 is confirmed with RT-PCR

  -\>18 years of age
* Being intubated less than 24 hours
* Not being planned to be extubated in 24 hours

Exclusion Criteria:

* COVID-19 is not confirmed with RT-PCR
* Having an impaired hemodynamic status
* Esophageal pathologies
* Bronchopleural fistula

Primary outcomes:
measure: Inspiratory Transpulmonary Pressure (Ptpins)
timeFrame: The first 24 hours of mechanical ventilation
Secondary outcomes:
measure: Expiratory Transpulmonary Pressure (Ptexp)
timeFrame: The first 24 hours of mechanical ventilation
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: 1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
Study officials:
affiliation: University of Health Sciences, Dr. Suat Seren Chest Diseases and Surgery Training and Research Center
name: Suleyman Yildirim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: