SARS CoV 2 InfectionNCT04995289
Prone Position During ECMO in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Hypoxaemic Patient
An observational study of SARS CoV 2 Infection and Hypoxemic Respiratory Failure, run by Mohammed VI University Hospital at 1 site in Morocco.
Trial summary
Introduction: The main manifestation of COVID-19 pneumonia is acute respiratory distress syndrome (ARDS), which in some cases can be more severe than intubation, extracorporeal membrane venous oxygenation (VV-ECMO) to ensure hematosis. Despite support from VV-ECMO, some patients may remain hypoxemic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS CoV 2 Infection, Hypoxemic Respiratory Failure
- What is being tested?
- Prone position on ECMO patient
- How many people
- 23 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Jan 2020to 30 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 23 patients admitted to the intensive care unit of different genders and ethnicities were included.
Who may be able to join
- Clinical diagnosis of SARS COV 2 infection complicated by ARDS, and needed a VV ECMO.
- patient who presented refractory hypoxemia during VV ECMO.
Who cannot join
- patient who has received ECMO V-A or ECMO VV for reasons other than ARDS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prone Position During ECMO in Covid Hypoxaemic Patient :A PROCESS-compliant Case Series From the Eastern Morocco
Introduction:
The main manifestation of COVID-19 pneumonia is acute respiratory distress syndrome (ARDS), which in some cases can be more severe than intubation, extracorporeal membrane venous oxygenation (VV-ECMO) to ensure hematosis. Despite support from VV-ECMO, some patients may remain hypoxemic. One possible therapeutic procedure for these patients is the application of the prone position.
Read more
Objective:
The main aim of this study was to investigate the modification of the PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO with refractory hypoxemia. The secondary objective was to evaluate the safety and feasibility of the inclined position for ECMO.
Methods:
the investigators reviewed the electronic records and lists of all 23 COVID-19 patients. were placed for the first time in PP with an average duration of 16 h . patient characteristics, pre-ECMO characteristics, ventilator/ECMO settings, and changes in ventilator/ECMO settings and blood gas analysis before and after PP.
Read the detailed description
The main objective of the current study was to investigate the change in PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO patients with persistent hypoxemia. Measurements were taken before PP, 1 h after the start of the PP, at the end of the PP cycle.
The secondary objective of this study was to assess the safety and feasibility of emergency positioning for patients with severe ARDS during ECMO treatment.
- Being tested
- Prone position on ECMO patient
- Keywords
- ECMO, ARDS, Prone position, COVID, compliance
- Medical subject headings
- COVID-19, Respiratory Insufficiency, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone position on ECMO patientOther
blood gas analysis before and after PP
What is being measured
The primary outcome is the main question the study is designed to answer.
amelioration of PaO2/FiO2
the investigators recoordeed Blood gas analysis before and after Prone position
Measured: through study completion, an average of 1 yea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Jan 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed VI University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Oujidi, Mohammed VI University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995289
- Sponsor's protocol ID
- MohammedVIUH
- Status last verified
- Aug 2021
- First submitted
- 28 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Position During ECMO in Covid Hypoxaemic Patient :A PROCESS-compliant Case Series From the Eastern Morocco
- ClinicalTrials.gov ID
- NCT04995289
- Acronym / sponsor ID
- MohammedVIUH
- Keywords
- ECMO, ARDS, Prone position, COVID, compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mohammed VI University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 6 Aug 2021 (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.
Introduction:
The main manifestation of COVID-19 pneumonia is acute respiratory distress syndrome (ARDS), which in some cases can be more severe than intubation, extracorporeal membrane venous oxygenation (VV-ECMO) to ensure hematosis. Despite support from VV-ECMO, some patients may remain hypoxemic. One possible therapeutic procedure for these patients is the application of the prone position.
Objective:
The main aim of this study was to investigate the modification of the PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO with refractory hypoxemia. The secondary objective was to evaluate the safety and feasibility of the inclined position for ECMO.
Methods:
the investigators reviewed the electronic records and lists of all 23 COVID-19 patients. were placed for the first time in PP with an average duration of 16 h . patient characteristics, pre-ECMO characteristics, ventilator/ECMO settings, and changes in ventilator/ECMO settings and blood gas analysis before and after PP.
Detailed description
The main objective of the current study was to investigate the change in PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO patients with persistent hypoxemia. Measurements were taken before PP, 1 h after the start of the PP, at the end of the PP cycle.
The secondary objective of this study was to assess the safety and feasibility of emergency positioning for patients with severe ARDS during ECMO treatment.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 23 patients admitted to the intensive care unit of different genders and ethnicities were included.
Key inclusion criteria (2 listed)
- Clinical diagnosis of SARS COV 2 infection complicated by ARDS, and needed a VV ECMO.
- patient who presented refractory hypoxemia during VV ECMO.
Key exclusion criteria (1 listed)
- patient who has received ECMO V-A or ECMO VV for reasons other than ARDS.
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 position on ECMO patientblood gas analysis before and after PP | Other | – |
Primary outcome
amelioration of PaO2/FiO2
Time frame: through study completion, an average of 1 yea
the investigators recoordeed Blood gas analysis before and after Prone position
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 13 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CoV 2 Infection and Hypoxemic Respiratory Failure, run by Mohammed VI University Hospital at 1 site in Morocco.
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 2 inclusion and 1 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 13 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 Morocco. 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?
amelioration of PaO2/FiO2 (time frame: through study completion, an average of 1 yea). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2021.