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

NCT ID: NCT04475068

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2020-10-31

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.

Detailed Description

The PRM is based on the known effect of gravity on transpulmonary pressure (PL). Two principles explain its mechanism of action: 1) the first indicates that atelectasis and poorly ventilated areas of the lung can improve their aeration by putting the lung in the highest position. Opposite lateral decubitus causes that upper lung to have a higher PL and allow a recruiting effect at moderate airway pressures. 2) The second principle is based on Laplace's Law and postulates that once the upper lung is recruited, it remains without lung collapse if a sufficient level of positive end-expiratory pressure (PEEP) is applied. Based on these two precepts, PRM consists of sequentially moving the patient from the supine to the left lateral decubitus to recover the aeration of the right lung. After that, the patient is placed in the right lateral position to recruit the left lung; keeping the right lung without collapse by continuous use of PEEP. Finally, the patient returns to the supine position looking for an improvement in the distribution of ventilation and global pulmonary aeration, with a subsequent improvement in gas exchange and pulmonary mechanics.

Conditions

Sars-CoV2; ARDS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Lateral Position (left and right lateral decubitus)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Contraindication for EIT monitoring

1. Unstable spine or pelvic fractures

2. Pacemaker, automatic implantable cardioverter defibrillator

3. Skin lesions between the 4th and 5th ribs where the EIT belt is worn

• Pregnancy
• Major hemodynamic instability::

1. Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and use of vasopressors.

2. FC> 120 or <60 per minute

3. Presence of uncontrolled arrhythmias.

• More than 1 week of mechanical ventilation
• Failure of more than 2 extrapulmonary organs.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Piura

UNKNOWN

Sponsor Role: collaborator

Hospital Nacional Edgardo Rebagliati Martins

OTHER

Sponsor Role: lead

Responsible Party

Rollin Roldán

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rollin Roldán, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Nacional Edgardo Rebagliati Martins

Locations

Hospital Rebagliati

Jesús María, Lima, Peru

Countries

Peru

References

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.

Reference Type: DERIVED

PMID: 35150355 (View on PubMed)

Other Identifiers

HNEdgardoRebagliatiMartins

Identifier Type: -

Identifier Source: org_study_id