Acute Respiratory Distress SyndromeNCT05535543
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome and Ventilation Perfusion Mismatch, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effects of prone positioning on homogenization of ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Ventilation Perfusion Mismatch, Respiratory Failure
- What is being tested?
- Prone Positioning
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2022to 28 Feb 2025
- How long will I take part?
- 1 Day
- 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 mixed critical care patients
Who may be able to join
- ARDS criteria met
- intubated and mechanically ventilated as a result of respiratory failure
- PaO2/FiO2 <200
Who cannot join
- age older than 18
- Chronic pulmonary disease, pneumothoraces, intraabdominal hypertension (> 12 mmHg), pregnancy, not expected to survive >24 hours, hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hamidiye Etfal Hospital
Istanbul, 34000
Olcay Dilken, MD, +905547378709, olcaydilken@gmail.com
About this study
Official title: Assessment of the Effects of Prone Positioning Among ARDS Patients on Ventilation Homogenization by the Phase Iii Slope of the Volumetric Capnography
This study evaluates the effects of prone positioning on homogenization of ventilation.
Read the detailed description
After initiation of mechanical ventilation and assessing the eligibility of the patient, informed consent will be taken from the closest kin. If eligible, following steps will be performed which are part of standard ARDS patient care.
- Low-flow Pressure Volume curve and assessment of airway opening pressure
- Calculation of recruitment to inflation ratio
- Optimizing Positive End-Expiratory Pressure
Afterwards, phase III slope of the patient will be recorded at four timepoints:
Supine 1 (immediately before turning to prone position) Prone 1 (immediately after prone position) Prone 2 (at the end of the 16-24 hour prone cycle) Supine 2 (immediately after turning to supine position)
- Being tested
- Prone Positioning
- Keywords
- Acute Respiratory Distress Syndrome, Volumetric Capnography, phase iii slope, prone
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositioningProcedure or surgery
Patients will be turned to prone position and they will be left in prone position for a duration of at least 16 hours to a maximum of 24 hours. This duration is recommended by the ARDS guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Baseline slope of phase iii | Severe ARDS patients who are intubated and mechanically ventilated and will undergo prone positioning Receives: Procedure: Prone Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in phase iii slope of the volumetric capnograph
phase iii slope is associated with the ventilation homogeneity
Measured: 16 to 24 hours (according to time spent in the prone position)
correlation of the phase iii slope with the recruitment to inflation ratio
recruitment to inflation ratio is a simple bedside tool that indicates a higher possible recruitable lung with higher applied Positive End-Expiratory Pressure
Measured: 16 to 24 hours (according to time spent in the prone position)
Secondary outcomes (1)
correlation of the phase iii slope with the Partial pressure of the arterial oxygen/ Fraction of inspired O2 concentration (PaO2/FiO2) ratio
PaO2/FiO2 is markedly reduced in ARDS patients as a consequence of aeration loss
Measured: 16 to 24 hours (according to time spent in the prone position)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start6 Sep 2022
- Primary completion30 Jan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (estimated)
- Target duration
- 1 Day
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, MD, Principal investigator, Hamidiye Etfal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535543
- Sponsor's protocol ID
- 05072022-3605
- Status last verified
- Jul 2024
- First submitted
- 7 Sep 2022
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Prone Positioning Among ARDS Patients on Ventilation Homogenization by the Phase Iii Slope of the Volumetric Capnography
- ClinicalTrials.gov ID
- NCT05535543
- Acronym / sponsor ID
- 05072022-3605
- Keywords
- Acute Respiratory Distress Syndrome, Volumetric Capnography, phase iii slope, prone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 10 Sep 2022 (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.
This study evaluates the effects of prone positioning on homogenization of ventilation.
Detailed description
After initiation of mechanical ventilation and assessing the eligibility of the patient, informed consent will be taken from the closest kin. If eligible, following steps will be performed which are part of standard ARDS patient care.
- Low-flow Pressure Volume curve and assessment of airway opening pressure
- Calculation of recruitment to inflation ratio
- Optimizing Positive End-Expiratory Pressure
Afterwards, phase III slope of the patient will be recorded at four timepoints:
Supine 1 (immediately before turning to prone position) Prone 1 (immediately after prone position) Prone 2 (at the end of the 16-24 hour prone cycle) Supine 2 (immediately after turning to supine position)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline slope of phase iii | – | Procedure: Prone PositioningSevere ARDS patients who are intubated and mechanically ventilated and will undergo prone positioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult mixed critical care patients
Key inclusion criteria (3 listed)
- ARDS criteria met
- intubated and mechanically ventilated as a result of respiratory failure
- PaO2/FiO2 <200
Key exclusion criteria (2 listed)
- age older than 18
- Chronic pulmonary disease, pneumothoraces, intraabdominal hypertension (> 12 mmHg), pregnancy, not expected to survive >24 hours, hemodynamic instability
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 PositioningPatients will be turned to prone position and they will be left in prone position for a duration of at least 16 hours to a maximum of 24 hours. This duration is recommended by the ARDS guidelines. | Procedure or surgery | Baseline slope of phase iii |
Primary outcome
Change from baseline in phase iii slope of the volumetric capnograph
Time frame: 16 to 24 hours (according to time spent in the prone position)
phase iii slope is associated with the ventilation homogeneity
correlation of the phase iii slope with the recruitment to inflation ratio
Time frame: 16 to 24 hours (according to time spent in the prone position)
recruitment to inflation ratio is a simple bedside tool that indicates a higher possible recruitable lung with higher applied Positive End-Expiratory Pressure
1 secondary outcome
correlation of the phase iii slope with the Partial pressure of the arterial oxygen/ Fraction of inspired O2 concentration (PaO2/FiO2) ratio
Time frame: 16 to 24 hours (according to time spent in the prone position)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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, MD principal investigator
Hamidiye Etfal Hospital
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 Ventilation Perfusion Mismatch, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olcay Dilken, MD (+905547378709, olcaydilken@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in phase iii slope of the volumetric capnograph (time frame: 16 to 24 hours (according to time spent in the prone position)). 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?
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 3 Jul 2024.