Clinical trial NCT04475068: Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection
Official title: Feasibility and Physiological Effects of a Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
ARDS
Lead sponsor: Hospital Nacional Edgardo Rebagliati Martins
Sponsor class: OTHER
Collaborators: name: Universidad de Piura
First posted: 2020-07-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Effects of a postural recruitment maneuver in lung aeration
timeFrame: Through study completion (up to 24 hours)
measure: Effects of a postural recruitment maneuver in distribution of ventilation
timeFrame: Through study completion (up to 24 hours)
measure: Effects of a postural recruitment maneuver in gas exchange
timeFrame: Through study completion (up to 24 hours)
measure: Effects of a postural recruitment maneuver in respiratory mechanics
timeFrame: Through study completion (up to 24 hours)
measure: Effects of a postural recruitment maneuver in hemodynamic
timeFrame: Through study completion (up to 24 hours)
Secondary outcomes:
measure: Feasibility of a postural recruitment maneuver
timeFrame: Through study completion (up to 24 hours)
Other outcomes:
Locations:
city: Jesús María
country: Peru
facility: Hospital Rebagliati
state: Lima
Study officials:
affiliation: Hospital Nacional Edgardo Rebagliati Martins
name: Rollin Roldán, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.