Acute Respiratory Distress SyndromeNCT05677165
The Relationship Between Driving Pressure, Mechanical Power, Oxygenation and Saturation Indices: Retrospective Observational Study
An observational study of Acute Respiratory Distress Syndrome and Pneumonia, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
By using Mechanical Power and Driving Pressure instead of Pmean we calculate new oxygen saturation indices like Driving Pressure Oxygen Index (OIDP), Dynamic Power Oxygen Index (OIMPdyn), Total Power Oxygen Index (OIMPtot), Driving Pressure Saturation Index (OSIDP), Dynamic Power Saturation Index (OSIMPdyn) ve Power… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Pneumonia
- How many people
- 361 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2020to 28 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The data of 784 patients with a diagnosis of Covid-19 hospitalized in the 28-bed intensive care unit of the Bakirkoy Dr. Sadi Konuk Training and Research Hospital were obtained by using structured query language (sql) queries from the 'ImdSoft-Metavision/QlinICU Clinical Decision Support (Israel) system'.173 patients who did not receive invasive mechanical ventilation support, 64 patients who stayed in the intensive care unit for less than 24 hours, 40 patients with missing data, and 38 patients who received mechanical ventilation support for less than 24 hours were excluded from the study.24 patients with COPD, 27 patients with congestive heart failure, and 11 patients who underwent tube thoracostomy due to tension pneumothorax were excluded from the study.In addition, 46 patients who received ECMO support were excluded from the study due to the possibility that ECMO may have an effect on respiratory variables. The remaining 361 patients were included in the study.
Who may be able to join
- Patients with a diagnosis of Covid-19 related Acute Respiratory Syndrome (C-ARDS) which hospitalized in Bakirköy Dr. Sadi Konuk Training and Research Hospital intensive care unit
Who cannot join
- Patients who did not receive invasive mechanical ventilation support.
- Patients who stayed in the intensive care unit for less than 24 hours.
- Patients with missing data
- Patients who received mechanical ventilation support for less than 24 hours
- Patients with Chronic Obstructive Pulmonary Disease (COPD).
- Patients with congestive heart failure
- Patients who underwent tube thoracostomy due to tension pneumothorax
- Patients who received Extracorporeal Membrane Oxygenation (ECMO) support
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirköy Dr sadi konuk Education hospital
Istanbul
About this study
By using Mechanical Power and Driving Pressure instead of Pmean we calculate new oxygen saturation indices like Driving Pressure Oxygen Index (OIDP), Dynamic Power Oxygen Index (OIMPdyn), Total Power Oxygen Index (OIMPtot), Driving Pressure Saturation Index (OSIDP), Dynamic Power Saturation Index (OSIMPdyn) ve Power Saturation Index (OSIMPtot).
New oxygenation and saturation indices are able to predict ICU mortality better than the conventional indexes and rates.
- Conditions
- Acute Respiratory Distress Syndrome, Pneumonia
- Keywords
- acute respiratory distress syndrome, pneumonia, oxygenation index, saturation index
- Medical subject headings
- Respiratory Distress Syndrome, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality
we estimate hospital mortality mortality by calculating new oxygenation index
Measured: 28 days
Secondary outcomes (1)
Mechanical ventilatory free days
we estimate hospital mortality mortality by calculating new saturation index
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start18 Mar 2020
- Primary completion1 Nov 2021
- Study completion28 Nov 2021
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.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677165
- Sponsor's protocol ID
- 2021/293
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Driving Pressure, Mechanical Power, Oxygenation and Saturation Indices: Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05677165
- Acronym / sponsor ID
- 2021/293
- Conditions
- Acute Respiratory Distress Syndrome, Pneumonia
- Keywords
- acute respiratory distress syndrome, pneumonia, oxygenation index, saturation index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 10 Jan 2023 (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.
By using Mechanical Power and Driving Pressure instead of Pmean we calculate new oxygen saturation indices like Driving Pressure Oxygen Index (OIDP), Dynamic Power Oxygen Index (OIMPdyn), Total Power Oxygen Index (OIMPtot), Driving Pressure Saturation Index (OSIDP), Dynamic Power Saturation Index (OSIMPdyn) ve Power Saturation Index (OSIMPtot).
New oxygenation and saturation indices are able to predict ICU mortality better than the conventional indexes and rates.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data of 784 patients with a diagnosis of Covid-19 hospitalized in the 28-bed intensive care unit of the Bakirkoy Dr. Sadi Konuk Training and Research Hospital were obtained by using structured query language (sql) queries from the 'ImdSoft-Metavision/QlinICU Clinical Decision Support (Israel) system'.173 patients who did not receive invasive mechanical ventilation support, 64 patients who stayed in the intensive care unit for less than 24 hours, 40 patients with missing data, and 38 patients who received mechanical ventilation support for less than 24 hours were excluded from the study.24 patients with COPD, 27 patients with congestive heart failure, and 11 patients who underwent tube thoracostomy due to tension pneumothorax were excluded from the study.In addition, 46 patients who received ECMO support were excluded from the study due to the possibility that ECMO may have an effect on respiratory variables. The remaining 361 patients were included in the study.
Key inclusion criteria (1 listed)
- Patients with a diagnosis of Covid-19 related Acute Respiratory Syndrome (C-ARDS) which hospitalized in Bakirköy Dr. Sadi Konuk Training and Research Hospital intensive care unit
Key exclusion criteria (8 listed)
- Patients who did not receive invasive mechanical ventilation support.
- Patients who stayed in the intensive care unit for less than 24 hours.
- Patients with missing data
- Patients who received mechanical ventilation support for less than 24 hours
- Patients with Chronic Obstructive Pulmonary Disease (COPD).
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
In hospital mortality
Time frame: 28 days
we estimate hospital mortality mortality by calculating new oxygenation index
1 secondary outcome
Mechanical ventilatory free days
Time frame: 30 days
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 10 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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 Acute Respiratory Distress Syndrome and Pneumonia, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 8 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 10 Jan 2023. 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?
In hospital mortality (time frame: 28 days). 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 10 Jan 2023.