Sars-CoV2NCT04475068
Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection
An observational study of Sars-CoV2 and ARDS, run by Hospital Nacional Edgardo Rebagliati Martins at 1 site in Peru.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lateral Position (left and right lateral decubitus)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 sitePeru
- Study dates
- 17 Jul 2020to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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::
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Physiological Effects of a Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection
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.
Read the 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.
- Being tested
- Lateral Position (left and right lateral decubitus)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Position (left and right lateral decubitus)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Lateral Position (left and right lateral decubitus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Through study completion (up to 24 hours)
Secondary outcomes (1)
Feasibility of a postural recruitment maneuver
Oxigenatory tolerance evaluated with pulse oximeter (arterial oxygen saturation, in percentage)
Measured: Through study completion (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start17 Jul 2020
- Primary completion30 Sep 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional Edgardo Rebagliati Martins
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Piura
- Responsible party
- Principal investigator, Rollin Roldán, Hospital Nacional Edgardo Rebagliati Martins
- Investigators
- Rollin Roldán, MD, Principal investigator, Hospital Nacional Edgardo Rebagliati Martins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475068
- Sponsor's protocol ID
- HNEdgardoRebagliatiMartins
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35150355
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Physiological Effects of a Postural Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04475068
- Acronym / sponsor ID
- HNEdgardoRebagliatiMartins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospital Nacional Edgardo Rebagliati MartinsUniversity, hospital or other
- Collaborators
- Universidad de Piura
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate to severe ARDS patients due to COVID-19 infection | – | Procedure: Lateral Position (left and right lateral decubitus)Mechanically ventilated patients with moderate to severe ARDS due to COVID-19 infection admitted to the COVID Intensive Care Unit of Rebagliati Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Contraindication for EIT monitoring
- Pregnancy
- Major hemodynamic instability::
- More than 1 week of mechanical ventilation
- Failure of more than 2 extrapulmonary organs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Moderate to severe ARDS patients due to COVID-19 infection |
Primary outcome
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).
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)
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)
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)
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)
1 secondary outcome
Feasibility of a postural recruitment maneuver
Time frame: Through study completion (up to 24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 35150355Roldan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rollin Roldán, MD principal investigator
Hospital Nacional Edgardo Rebagliati Martins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2 and ARDS, run by Hospital Nacional Edgardo Rebagliati Martins at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of a postural recruitment maneuver in lung aeration (time frame: Through study completion (up to 24 hours)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.