Acute Respiratory Distress SyndromeNCT05387356
Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU
An observational study of Acute Respiratory Distress Syndrome and COVID-19 Respiratory Infection, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Thirty -one confirmed Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 ) infected patients with Acute Respiratory Distress Syndrome (ARDS) and placed in prone position(PP) for 3 times (PP1, PP2, PP3)consecutively will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, COVID-19 Respiratory Infection
- What is being tested?
- prone position
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2022to 10 Jun 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
- Adult, Older adult
Study population: Intensive care patient population who were intubated a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. -
Who may be able to join
- a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. -
Who cannot join
- negative test result for SARS-CoV-2 RNA -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University
Ankara
esra ozayar, 905055025497, eozayar@yahoo.com.tr
About this study
Official title: Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU: A Retrospective Study
Thirty -one confirmed Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 ) infected patients with Acute Respiratory Distress Syndrome (ARDS) and placed in prone position(PP) for 3 times (PP1, PP2, PP3)consecutively will be included. Arterial blood gases (ABG), partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FiO2 ) ratios, partial pressure of carbondioxide (PaCO2), positive end expiratory pressure (PEEP), and fraction of inspired oxygen (FiO2) values will be recorded before (bPP), during (dPP)and after (aPP) every prone positioning. Eye, skin, nerve and tube complications related to prone positions wll be recorded
- Being tested
- prone position
- Keywords
- prone position, intensive care unit
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionOther
thirty-one patients who had a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. Medical datas of the patients will be obtained from patients' files which are strictly filled during pandemic. Prone position indication of intensive care unit (ICU) is in case of severe ARDS with PaO2/FiO2 <150 despite a PEEP >10 cmH2O.
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of prone position
The investigators will evaluate the arterial blood gase results and ventilator settings before after and during prone position
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start23 May 2022
- Primary completion10 Jun 2022 (estimated)
- Study completion10 Jun 2022 (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.
- 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
- Retrospective
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA OZAYAR, Kecioren Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387356
- Sponsor's protocol ID
- Prone Position
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 27 May 2022
- 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 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05387356
- Acronym / sponsor ID
- Prone Position
- Keywords
- prone position, intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 10 Jun 2022 (estimated)
- First posted
- 24 May 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.
Thirty -one confirmed Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 ) infected patients with Acute Respiratory Distress Syndrome (ARDS) and placed in prone position(PP) for 3 times (PP1, PP2, PP3)consecutively will be included. Arterial blood gases (ABG), partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FiO2 ) ratios, partial pressure of carbondioxide (PaCO2), positive end expiratory pressure (PEEP), and fraction of inspired oxygen (FiO2) values will be recorded before (bPP), during (dPP)and after (aPP) every prone positioning. Eye, skin, nerve and tube complications related to prone positions wll be recorded
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Intensive care patient population who were intubated a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. -
Key inclusion criteria (1 listed)
- a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. -
Key exclusion criteria (1 listed)
- negative test result for SARS-CoV-2 RNA -
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 positionthirty-one patients who had a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. Medical datas of the patients will be obtained from patients' files which are strictly filled during pandemic. Prone position indication of intensive care unit (ICU) is in case of severe ARDS with PaO2/FiO2 <150 despite a PEEP >10 cmH2O. | Other | – |
Primary outcome
effects of prone position
Time frame: 15 days
The investigators will evaluate the arterial blood gase results and ventilator settings before after and during prone position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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.
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 COVID-19 Respiratory Infection, run by Kecioren Education 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 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: status not confirmed, as of the sponsor's last update on 27 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of prone position (time frame: 15 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 27 May 2022.