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Closed Loop Ventilation in Patients With COVID-19

Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04873336
Collaborator
(none)
20
Enrollment
1
Location
6.5
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tidal Volumes Are Generated Automatically With Closed Loop Ventilation (INTELLIVENT ASV) is Safe in Patients With COVID-19
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Oct 15, 2021
Actual Study Completion Date :
Oct 16, 2021

Outcome Measures

Primary Outcome Measures

  1. Inspiratory Transpulmonary Pressure (Ptpins) [The first 24 hours of mechanical ventilation]

    Ptpinsp will be measured with an inspiratory hold maneuver

Secondary Outcome Measures

  1. Expiratory Transpulmonary Pressure (Ptexp) [The first 24 hours of mechanical ventilation]

    Ptpexp will be measured with an expiratory hold maneuver

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit İzmir Turkey 35110

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cenk Kirakli, M.D., Professor Doctor Cenk KIRAKLI, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT04873336
Other Study ID Numbers:
  • IGHCEAH-ICU-5
First Posted:
May 5, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cenk Kirakli, M.D., Professor Doctor Cenk KIRAKLI, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Mechanical ventilation
Adaptive support ventilation
Transpulnonary pressure
Safety
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Nov 16, 2021