Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04475068|
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment|
|Sars-CoV2 ARDS||Procedure: Lateral Position (left and right lateral decubitus)|
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|Official Title:||Feasibility and Physiological Effects of a Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection|
|Actual Study Start Date :||July 17, 2020|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||October 2020|
Moderate to severe ARDS patients due to COVID-19 infection
Mechanically ventilated patients with moderate to severe ARDS due to COVID-19 infection admitted to the COVID Intensive Care Unit of Rebagliati Hospital.
Procedure: Lateral Position (left and right lateral decubitus)
Prior to initiating the protocol, patients will be sedated deeply with sedatives and opioids and paralyzed. Patients will be evaluated in 5 positions sequentially: 1) Supine 2) Left lateral 3) Supine 4) Right lateral 5) Supine. The side with the least ventilation evaluated by EIT will define which side will start the sequence. Each step will last 30 minutes. Aeration measured by Electric Impedance Tomography (EIT) and lung ultrasound, distribution of the lung ventilation and perfusion measured by EIT, ventilator and hemodynamic parameters, esophageal pressure, and blood gas analysis will be recorded at the end of each step. Continuous monitoring of blood pressure, heart rate and saturation of arterial blood (SpO2) will be carried out during all steps of the protocol to assess the tolerance to the procedure.
- Effects of a postural recruitment maneuver in lung aeration [ Time Frame: Through study completion (up to 24 hours) ]Lung aeration measured by ultrasound reaeration score, ranges from 0 (all regions are well aerated) to 36 (all regions are consolidated).
- Effects of a postural recruitment maneuver in distribution of ventilation [ Time Frame: Through study completion (up to 24 hours) ]Distribution of ventilation measured by EIT (distribution and changes in the impedance in AU, arbitray units)
- Effects of a postural recruitment maneuver in gas exchange [ Time Frame: Through study completion (up to 24 hours) ]Gas exchange measured by blood gas analysis (PaO2, PaCO2, in mmHg) and capnography (end-tidal CO2, in mmHg)
- Effects of a postural recruitment maneuver in respiratory mechanics [ Time Frame: Through study completion (up to 24 hours) ]Respiratory mechanics measured by esophageal balloon (esophageal pressure, transpulmonary pressure, in cmH2O)
- Effects of a postural recruitment maneuver in hemodynamic [ Time Frame: Through study completion (up to 24 hours) ]Hemodynamic data measured by invasive arterial monitoring (mean arterial pressure, in mmHg)
- Feasibility of a postural recruitment maneuver [ Time Frame: Through study completion (up to 24 hours) ]Oxigenatory tolerance evaluated with pulse oximeter (arterial oxygen saturation, in percentage)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475068
|Contact: Rollin Roldán, MD||+51 email@example.com|
|Principal Investigator:||Rollin Roldán, MD||Hospital Nacional Edgardo Rebagliati Martins|