Acute Respiratory Distress SyndromeNCT04818164
Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome and Coronavirus, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Covid-19 associated Acute Respiratory Distress Syndrome (ARDS) may present with profound hypoxemia not fully explained with pulmonary infiltrates. Accordingly, how prone positioning improves oxygenation in these patients is not fully known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Coronavirus, Mechanical Ventilation Complication
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Mar 2022
- 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: Adult Patients receiving invasive mechanic ventilation due to Covid-19 ARDS
Who may be able to join
- Patients were considered eligible if they met the Berlin definition criteria for ARDS and intubated due to increased work of breathing and/or worsening hypoxemia. All patients had a positive Covid-19 real time Polymerase Chain Reaction test
Who cannot join
- Exclusion criteria were; age < 18 years, ARDS resulting from other risk factors, presence of chest drainage tubes, tracheostomy, pneumomediastinum, hemodynamic instability (systolic blood pressure < 100 mmHg, lactate > 2 mmol/l, or an increase in lactate concentrations for 20% in two consecutive blood gas analysis within 2 hours interval) and suspicion or confirmed pulmonary emboli.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Associated Acute Respiratory Distress Syndrome: An Observational Study
Covid-19 associated Acute Respiratory Distress Syndrome (ARDS) may present with profound hypoxemia not fully explained with pulmonary infiltrates. Accordingly, how prone positioning improves oxygenation in these patients is not fully known. The investigators conducted a study among patients with severe Covid-19 ARDS receiving prone position for at least 16 hours. End Expiratory Lung Volume (EELV) was measured with Nitrogen wash-in/wash-out technique before (Supine Position 1- SP1), during (Prone Position - PP) and after (Supine Position 2 - SP2) prone positioning.
Read the detailed description
After initiation of invasive mechanical ventilation, initial ventilator settings were performed by the attending physician. These settings include titration of best PEEP to promote oxygenation if Spo2 <92% despite a Fio2 higher than 80% or best compliance that do not jeopardize oxygenation if Fio2 is between 50-80% and Spo2 >92%. After a period of 30 minutes for stabilisation, the first set of measurements were done in the SP1 position. Afterwards, the patient was turned to prone position with the same PEEP (which was unchanged throughout the study period) and measurements were repeated every four hours until the patient was reverted back to SP2. Eventually, there were 7 measurements in total. (SP1, PP0, PP4, PP8, PP12, PP16, SP2). Dead space ventilation and shunt fraction calculations were made based on central venous blood gas measurements and oxygen consumption and carbon dioxide production at the relevant timepoint.
- Conditions
- Acute Respiratory Distress Syndrome, Coronavirus, Mechanical Ventilation Complication, Ventilation Perfusion Mismatch
- Keywords
- acute respiratory distress syndrome, prone position, lung recruitment
- Medical subject headings
- Respiratory Distress Syndrome, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Pressure of Oxygen/ Fraction of Inspired Oxygen
Oxygenation
Measured: 1 day
End Expiratory Lung Volume
Oxygenation
Measured: 1 day
Secondary outcomes (2)
Lung Compliance
Change in Recruitable Lung Volume
Measured: 1 day
Dead Space Ventilation
Fraction of Wasted Ventilation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Sep 2020
- Primary completion30 Sep 2021
- Study completion1 Mar 2022
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 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olcay Dilken, Istanbul University - Cerrahpasa
- Investigators
- Olcay Dilken, Dr., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818164
- Sponsor's protocol ID
- 2020-19-16163
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dilken O, Rezoagli E, Yartas Dumanli G, Urkmez S, Demirkiran O, Dikmen Y. Effect of prone positioning on end-expiratory lung volume, strain and oxygenation change over time in COVID-19 acute respiratory distress syndrome: A prospective physiological study. Front Med (Lausanne). 2022 Dec 2;9:1056766. doi: 10.3389/fmed.2022.1056766. eCollection 2022.
PubMed 36530873
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Associated Acute Respiratory Distress Syndrome: An Observational Study
- ClinicalTrials.gov ID
- NCT04818164
- Acronym / sponsor ID
- 2020-19-16163
- Conditions
- Acute Respiratory Distress Syndrome, Coronavirus, Mechanical Ventilation Complication, Ventilation Perfusion Mismatch
- Keywords
- acute respiratory distress syndrome, prone position, lung recruitment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 26 Mar 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.
Covid-19 associated Acute Respiratory Distress Syndrome (ARDS) may present with profound hypoxemia not fully explained with pulmonary infiltrates. Accordingly, how prone positioning improves oxygenation in these patients is not fully known. The investigators conducted a study among patients with severe Covid-19 ARDS receiving prone position for at least 16 hours. End Expiratory Lung Volume (EELV) was measured with Nitrogen wash-in/wash-out technique before (Supine Position 1- SP1), during (Prone Position - PP) and after (Supine Position 2 - SP2) prone positioning.
Detailed description
After initiation of invasive mechanical ventilation, initial ventilator settings were performed by the attending physician. These settings include titration of best PEEP to promote oxygenation if Spo2 <92% despite a Fio2 higher than 80% or best compliance that do not jeopardize oxygenation if Fio2 is between 50-80% and Spo2 >92%. After a period of 30 minutes for stabilisation, the first set of measurements were done in the SP1 position. Afterwards, the patient was turned to prone position with the same PEEP (which was unchanged throughout the study period) and measurements were repeated every four hours until the patient was reverted back to SP2. Eventually, there were 7 measurements in total. (SP1, PP0, PP4, PP8, PP12, PP16, SP2). Dead space ventilation and shunt fraction calculations were made based on central venous blood gas measurements and oxygen consumption and carbon dioxide production at the relevant timepoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients receiving invasive mechanic ventilation due to Covid-19 ARDS
Key inclusion criteria (1 listed)
- Patients were considered eligible if they met the Berlin definition criteria for ARDS and intubated due to increased work of breathing and/or worsening hypoxemia. All patients had a positive Covid-19 real time Polymerase Chain Reaction test
Key exclusion criteria (1 listed)
- Exclusion criteria were; age < 18 years, ARDS resulting from other risk factors, presence of chest drainage tubes, tracheostomy, pneumomediastinum, hemodynamic instability (systolic blood pressure < 100 mmHg, lactate > 2 mmol/l, or an increase in lactate concentrations for 20% in two consecutive blood gas analysis within 2 hours interval) and suspicion or confirmed pulmonary emboli.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Partial Pressure of Oxygen/ Fraction of Inspired Oxygen
Time frame: 1 day
Oxygenation
End Expiratory Lung Volume
Time frame: 1 day
Oxygenation
2 secondary outcomes
Lung Compliance
Time frame: 1 day
Dead Space Ventilation
Time frame: 1 day
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 4 Mar 2022.
- Derived from this study: PubMed 36530873Dilken O, Rezoagli E, Yartas Dumanli G, Urkmez S, Demirkiran O, Dikmen Y. Effect of prone positioning on end-expiratory lung volume, strain and oxygenation change over time in COVID-19 acute respiratory distress syndrome: A prospective physiological study. Front Med (Lausanne). 2022 Dec 2;9:1056766. doi: 10.3389/fmed.2022.1056766. eCollection 2022.
- 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.
Olcay Dilken, Dr. principal investigator
Istanbul University - Cerrahpasa
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 Acute Respiratory Distress Syndrome and Coronavirus, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 1 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 4 Mar 2022. 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 Turkey (Türkiye). 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?
Partial Pressure of Oxygen/ Fraction of Inspired Oxygen (time frame: 1 day). The study lists 2 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 NCT04818164, 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 4 Mar 2022.