Severe Acute Respiratory Syndrome Coronavirus 2COVID-19_EITNCT04359407
Prone Positioning and Regional Ventilation in Mechanically Ventilated COVID-19 Patients
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 and Electric Impedance, run by Walid HABRE at 1 site in Switzerland.
Trial summary
The consensus therapeutic strategy implies that COVID patients with acute lung injury due to coronavirus are routinely placed in prone position in an attempt to improve oxygenation by increasing ventilation homogeneity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2, Electric Impedance, Prone Positioning
- What is being tested?
- Prone positioning
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Apr 2020to 10 May 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe acute lung injury induced by the coronavirus necessitating intubation and ventilation with positioning on the ventral side.
Who may be able to join
- Patients fulfilling all the following criteria are eligible for the study:
- Mechanically ventilated
- Fit the Berlin Definition for moderate or severe acute respiratory distress syndrome (arterial oxygen partial pressure over inspiratory fraction of oxygen less than 200 mmHg)
- Infection with coronavirus confirmed
- Scheduled to undergo prone positioning
Who cannot join
- Patients with pacemakers, defibrillators or other electrically active implants
- Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings
- Patients with chest tubes
- History of thoracic surgery or lung resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prone Positioning on Lung Aeration and Ventilation-perfusion Matching in Mechanically Ventilated Patients With Coronavirus Disease Related Acute Respiratory Distress Syndrome
The consensus therapeutic strategy implies that COVID patients with acute lung injury due to coronavirus are routinely placed in prone position in an attempt to improve oxygenation by increasing ventilation homogeneity. The purpose of the study is to quantify with the electrical impedance tomography (EIT) the changes in the ventilation and aeration in the dorsal regions of the lung when the patient is placed in prone position.
Read the detailed description
Patients with acute respiratory distress syndrome (ARDS) frequently develop atelectasis in dorsal lung regions because of gravity and the compression by the heart and the diaphragm. Since lung perfusion is predominantly distributed in lower lung regions, a reduction of ventilation in these areas results in further ventilation-perfusion mismatch, called shunt. The development of atelectatic lung regions necessitate the use of higher ventilation pressures, which in turn results in excessive transpulmonary pressures and ventilation-induced lung injury in the ventral regions. Therefore it is common to promote the prone position in patients with ARDS in order to improve ventilation-perfusion matching and thus, protect the ventral regions from hyperinflation. In patients with COVID-19-related ARDS, the value of such therapeutic strategy based on placing in prone position has not been completely elucidated. The aims of the study are to determine whether prone positioning improves dorsal regional ventilation when compared to supine position. Moreover, another aim is to assess the changes in intrapulmonary shunt following patient position changes.
- Being tested
- Prone positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positioningOther
Change the positioning of the COVID patients who are intubated and mechanically ventilated from supine to prone
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal electrical Impedance
Change in the ratio of tidal electrical impedance variation in the dorsal and total lung areas
Measured: One hour before turning to prone or supine positioning
Secondary outcomes (2)
Intrapulmonary shunt
Changes in intrapulmonary shunt fraction
Measured: One hour before turning to prone or supine positioning
Volumetric capnography
Changes in the phase three slope of the volumetric capnogram
Measured: One hour before turning to prone or supine positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start27 Apr 2020
- Primary completion10 May 2021
- Study completion10 May 2021
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 Severe Acute Respiratory Syndrome Coronavirus 2Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid HABRE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walid HABRE, University Hospital, Geneva
- Investigators
- Walid Habre, MD, PhD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359407
- Sponsor's protocol ID
- 2020-00896
- Acronym
- COVID-19_EIT
- Status last verified
- Jul 2021
- First submitted
- 20 Apr 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dos Santos Rocha A, Diaper J, Balogh AL, Marti C, Grosgurin O, Habre W, Petak F, Sudy R. Effect of body position on the redistribution of regional lung aeration during invasive and non-invasive ventilation of COVID-19 patients. Sci Rep. 2022 Jun 30;12(1):11085. doi: 10.1038/s41598-022-15122-9.
PubMed 35773299
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prone Positioning on Lung Aeration and Ventilation-perfusion Matching in Mechanically Ventilated Patients With Coronavirus Disease Related Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04359407
- Acronym / sponsor ID
- COVID-19_EIT / 2020-00896
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Walid HABREUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 24 Apr 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 consensus therapeutic strategy implies that COVID patients with acute lung injury due to coronavirus are routinely placed in prone position in an attempt to improve oxygenation by increasing ventilation homogeneity. The purpose of the study is to quantify with the electrical impedance tomography (EIT) the changes in the ventilation and aeration in the dorsal regions of the lung when the patient is placed in prone position.
Detailed description
Patients with acute respiratory distress syndrome (ARDS) frequently develop atelectasis in dorsal lung regions because of gravity and the compression by the heart and the diaphragm. Since lung perfusion is predominantly distributed in lower lung regions, a reduction of ventilation in these areas results in further ventilation-perfusion mismatch, called shunt. The development of atelectatic lung regions necessitate the use of higher ventilation pressures, which in turn results in excessive transpulmonary pressures and ventilation-induced lung injury in the ventral regions. Therefore it is common to promote the prone position in patients with ARDS in order to improve ventilation-perfusion matching and thus, protect the ventral regions from hyperinflation. In patients with COVID-19-related ARDS, the value of such therapeutic strategy based on placing in prone position has not been completely elucidated. The aims of the study are to determine whether prone positioning improves dorsal regional ventilation when compared to supine position. Moreover, another aim is to assess the changes in intrapulmonary shunt following patient position changes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe acute lung injury induced by the coronavirus necessitating intubation and ventilation with positioning on the ventral side.
Key inclusion criteria (5 listed)
- Mechanically ventilated
- Fit the Berlin Definition for moderate or severe acute respiratory distress syndrome (arterial oxygen partial pressure over inspiratory fraction of oxygen less than 200 mmHg)
- Infection with coronavirus confirmed
- Scheduled to undergo prone positioning
Key exclusion criteria (4 listed)
- Patients with pacemakers, defibrillators or other electrically active implants
- Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings
- Patients with chest tubes
- History of thoracic surgery or lung resection
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 |
|---|---|---|
| Prone positioningChange the positioning of the COVID patients who are intubated and mechanically ventilated from supine to prone | Other | – |
Primary outcome
Tidal electrical Impedance
Time frame: One hour before turning to prone or supine positioning
Change in the ratio of tidal electrical impedance variation in the dorsal and total lung areas
2 secondary outcomes
Intrapulmonary shunt
Time frame: One hour before turning to prone or supine positioning
Volumetric capnography
Time frame: One hour before turning to prone or supine positioning
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 21 Jul 2021.
- Derived from this study: PubMed 35773299Dos Santos Rocha A, Diaper J, Balogh AL, Marti C, Grosgurin O, Habre W, Petak F, Sudy R. Effect of body position on the redistribution of regional lung aeration during invasive and non-invasive ventilation of COVID-19 patients. Sci Rep. 2022 Jun 30;12(1):11085. doi: 10.1038/s41598-022-15122-9.
- 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.
Walid Habre, MD, PhD principal investigator
University of Geneva, Switzerland
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 Severe Acute Respiratory Syndrome Coronavirus 2 and Electric Impedance, run by Walid HABRE at 1 site in Switzerland.
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 5 inclusion and 4 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 21 Jul 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 Switzerland. 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?
Tidal electrical Impedance (time frame: One hour before turning to prone or supine positioning). 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 NCT04359407, 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 21 Jul 2021.