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

ARDS Clinical Trial

Official title:

Feasibility and Physiological Effects of a Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475068
• Other study ID #: HNEdgardoRebagliatiMartins
• Status: Completed
• Start date: July 17, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: August 2021
• Source: Hospital Nacional Edgardo Rebagliati Martins
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sars-CoV2

Intervention

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.

Locations

Country	Name	City	State
Peru	Hospital Rebagliati	Jesús María	Lima

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Nacional Edgardo Rebagliati Martins	Universidad de Piura

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Feasibility of a postural recruitment maneuver	Oxigenatory tolerance evaluated with pulse oximeter (arterial oxygen saturation, in percentage)	Through study completion (up to 24 hours)