Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection

NCT04475068 | Completed

• 1 other identifier: HNEdgardoRebagliatiMartins
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if a postural recruitment maneuver (PRM) improves the aeration and distribution of lung ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 infection; without the need to reach high airway pressures as in the standard lung recruitment maneuver and / or place the patient in prone position. This strategy could be particularly useful in the context of a major health emergency in centers with limited resources.

Conditions

Sars-CoV2; ARDS

Outcome Measures

Primary Outcomes (5)

• Effects of a postural recruitment maneuver in lung aeration

  Lung aeration measured by ultrasound reaeration score, ranges from 0 (all regions are well aerated) to 36 (all regions are consolidated).

  Through study completion (up to 24 hours)

• Effects of a postural recruitment maneuver in distribution of ventilation

  Distribution of ventilation measured by EIT (distribution and changes in the impedance in AU, arbitray units)

  Through study completion (up to 24 hours)

• Effects of a postural recruitment maneuver in gas exchange

  Gas exchange measured by blood gas analysis (PaO2, PaCO2, in mmHg) and capnography (end-tidal CO2, in mmHg)

  Through study completion (up to 24 hours)

• Effects of a postural recruitment maneuver in respiratory mechanics

  Respiratory mechanics measured by esophageal balloon (esophageal pressure, transpulmonary pressure, in cmH2O)

  Through study completion (up to 24 hours)

• Effects of a postural recruitment maneuver in hemodynamic

  Hemodynamic data measured by invasive arterial monitoring (mean arterial pressure, in mmHg)

  Through study completion (up to 24 hours)

Secondary Outcomes (1)

• Feasibility of a postural recruitment maneuver

  Through study completion (up to 24 hours)

Study Arms (1)

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)

Interventions

Lateral Position (left and right lateral decubitus) PROCEDURE

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.

Moderate to severe ARDS patients due to COVID-19 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This physiological study will enroll 12 adult ARDS patients admitted to the COVID Intensive Care Unit of Rebagliati Hospital. Informed consent will be obtained from the patient or legally authorized substitute decision maker.

You may qualify if:

• Patients \> 18 years of age
• Patients with moderate-to-severe ARDS as per the Berlin definition
• Infection due to COVID-19
• Body mass index (BMI) ≤ 35 kg /m\^2.

You may not qualify if:

• Contraindication for EIT monitoring
• Unstable spine or pelvic fractures
• Pacemaker, automatic implantable cardioverter defibrillator
• Skin lesions between the 4th and 5th ribs where the EIT belt is worn
• Pregnancy
• Major hemodynamic instability::
• Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and use of vasopressors.
• FC\> 120 or \<60 per minute
• Presence of uncontrolled arrhythmias.
• More than 1 week of mechanical ventilation
• Failure of more than 2 extrapulmonary organs.

Sponsors & Collaborators

• Hospital Nacional Edgardo Rebagliati Martins: lead
• Universidad de Piura: collaborator

Study Sites (1)

Hospital Rebagliati

Jesús María, Lima, Lima 11, Peru

Location

Related Publications (1)

• Roldan R, Rodriguez S, Barriga F, Tucci M, Victor M, Alcala G, Villamonte R, Suarez-Sipmann F, Amato M, Brochard L, Tusman G. Sequential lateral positioning as a new lung recruitment maneuver: an exploratory study in early mechanically ventilated Covid-19 ARDS patients. Ann Intensive Care. 2022 Feb 12;12(1):13. doi: 10.1186/s13613-022-00988-9.

  PMID: 35150355 DERIVED

Study Officials

• Rollin Roldán, MD

  Hospital Nacional Edgardo Rebagliati Martins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: July 17, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)