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OpenTrials
Completed

NCT Number: NCT04873336

Closed Loop Ventilation 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Izmir, 35110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intellivent ASV

Device

A closed loop mechanical ventilation mode that adjusts oxygenization and ventilation automatically

Primary outcomes

  1. Inspiratory Transpulmonary Pressure (Ptpins)

    Time frame: The first 24 hours of mechanical ventilation

    Ptpinsp will be measured with an inspiratory hold maneuver

Secondary outcomes

  1. Expiratory Transpulmonary Pressure (Ptexp)

    Time frame: The first 24 hours of mechanical ventilation

    Ptpexp will be measured with an expiratory hold maneuver

Sponsors and collaborators

Lead sponsor

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 5, 2021
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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