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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
Sponsor:
Collaborator:
Universidad de Piura
Information provided by (Responsible Party):
Rollin Roldán, Hospital Nacional Edgardo Rebagliati Martins

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.

Condition or disease Intervention/treatment
Sars-CoV2 ARDS Procedure: Lateral Position (left and right lateral decubitus)

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.

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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)

  3. 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)

  4. 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)

  5. 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)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Rollin Roldán, MD +51 994339019 rollinroldan@yahoo.es

Locations
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Peru
Hospital Rebagliati Recruiting
Jesús María, Lima, Peru, Lima 11
Contact: Rollin Roldán, MD    +51 994339019    rollinroldan@yahoo.es   
Contact: Renán Villamonte, MD    +51 946123643    rvillamo@yahoo.com   
Sponsors and Collaborators
Hospital Nacional Edgardo Rebagliati Martins
Universidad de Piura
Investigators
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Principal Investigator: Rollin Roldán, MD Hospital Nacional Edgardo Rebagliati Martins
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Responsible Party: Rollin Roldán, Principal investigator, Hospital Nacional Edgardo Rebagliati Martins
ClinicalTrials.gov Identifier: NCT04475068    
Other Study ID Numbers: HNEdgardoRebagliatiMartins
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury