Closed Loop Ventilation in Patients With COVID-19

Tidal Volumes Are Generated Automatically With Closed Loop Ventilation (INTELLIVENT ASV) is Safe in Patients With COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Covid19; ARDS
• Intervention / Treatment: Device: Intellivent ASV

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35110
    • 1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient with COVID-19 who received invasive mechanical ventilation due to respiratory failure in intensive care unit

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory Transpulmonary Pressure (Ptpins)	Ptpinsp will be measured with an inspiratory hold maneuver	The first 24 hours of mechanical ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expiratory Transpulmonary Pressure (Ptexp)	Ptpexp will be measured with an expiratory hold maneuver	The first 24 hours of mechanical ventilation

Collaborators and Investigators

• Sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
• Investigators: Principal Investigator: Suleyman Yildirim, M.D., University of Health Sciences, Dr. Suat Seren Chest Diseases and Surgery Training and Research Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 16, 2021

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Mechanical ventilation; Adaptive support ventilation; Transpulnonary pressure
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IGHCEAH-ICU-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No