Severe Acute Respiratory SyndromeproneNCT06287554
Effect of Early Implementation of Prone Positioning
An observational study of Severe Acute Respiratory Syndrome, run by Zulekha Hospitals at 1 site in Egypt.
Trial summary
Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Severe Acute Respiratory Syndrome
- What is being tested?
- PRONE POSITION
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2020to 20 Apr 2022
- How long will I take part?
- 26 Months
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 124 patients were recruited initially to the study who were admitted with ARDS to the ICU. A total of 70 patients were finally included and divided into two groups,
Who may be able to join
- All patients of both sexes.
- Aged from 18 to 70 years.
- Body Mass Index (BMI) from 25 to 35 kg/m2.
- Critically ill due to ARDS resulting from COVID-19 pneumonia.
Who cannot join
- Patients who spent more than 24 hours on mechanical ventilators before enrolment in the study.
- Patients who died within the first 24 hours of presentation.
- Patients with advanced cancer.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Implementation of Prone Positioning Among Critically Ill Patients Admitted With Acute Respiratory Distress Syndrome During the COVID-19 Time: A Comparative Retrospective Observational Study
Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU.
Read the detailed description
Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU.
Methodology: This retrospective study was conducted on critically ill patients needing mechanical ventilation with lung protective strategy and admitted to the Intensive Care Units of Al-Azhar University Hospitals between March 2020 to April 2022. All patients in the study were interpreted retrospectively by examining the patient's records. Group A (n:39) included patients who had been early placed in prone positions within 24 hours of intubation, and Group B (n:31) included patients who had not been placed in prone positions. All patients received a lung protective strategy for ARDS. In both groups, PaO2, PaCo2, PH, SpO2, and PaO2/FiO2 ratio were checked initially and later every 24 hours for 6 days. All patients were evaluated for the total days of both hospital and ICU length of stay, number of successful discharges to home from the hospital, and the total number of tracheostomized patients.
- Conditions
- Severe Acute Respiratory Syndrome
- Being tested
- PRONE POSITION
- Keywords
- Prone, Lung protective, ARDS, APACHI II, SOFA
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRONE POSITIONOther
early placed in prone positions within 24 hours of intubation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A (n:39) included patients who had been early placed in prone positions within 24 hours of intubation Receives: Other: PRONE POSITION | |
| Group B | Group B (n:31) included patients who had not been placed in prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of discharged patients
Number of discharged patients
Measured: 26 MONTHS
Secondary outcomes (3)
The total length of stay
The total length of stay
Measured: 26 MONTHS
ICU length of stay
ICU length of stay
Measured: 26 MONTHS
Patients who underwent tracheostomy procedures
Patients who underwent tracheostomy procedures
Measured: 26 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start4 Mar 2020
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory 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
- Case-control
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
- Target duration
- 26 Months
Sponsor and investigators
- Lead sponsor
- Zulekha Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor
- Investigators
- SAMEH H SEYAM, PHD, Study chair, Consultant critical care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287554
- Sponsor's protocol ID
- 404/2024
- Acronym
- prone
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Implementation of Prone Positioning Among Critically Ill Patients Admitted With Acute Respiratory Distress Syndrome During the COVID-19 Time: A Comparative Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06287554
- Acronym / sponsor ID
- prone / 404/2024
- Conditions
- Severe Acute Respiratory Syndrome
- Keywords
- Prone, Lung protective, ARDS, APACHI II, SOFA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zulekha HospitalsUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 1 Mar 2024 (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.
Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU.
Detailed description
Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU.
Methodology: This retrospective study was conducted on critically ill patients needing mechanical ventilation with lung protective strategy and admitted to the Intensive Care Units of Al-Azhar University Hospitals between March 2020 to April 2022. All patients in the study were interpreted retrospectively by examining the patient's records. Group A (n:39) included patients who had been early placed in prone positions within 24 hours of intubation, and Group B (n:31) included patients who had not been placed in prone positions. All patients received a lung protective strategy for ARDS. In both groups, PaO2, PaCo2, PH, SpO2, and PaO2/FiO2 ratio were checked initially and later every 24 hours for 6 days. All patients were evaluated for the total days of both hospital and ICU length of stay, number of successful discharges to home from the hospital, and the total number of tracheostomized patients.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 26 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: PRONE POSITIONGroup A (n:39) included patients who had been early placed in prone positions within 24 hours of intubation |
| Group B | – | –Group B (n:31) included patients who had not been placed in prone position |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 124 patients were recruited initially to the study who were admitted with ARDS to the ICU. A total of 70 patients were finally included and divided into two groups,
Key inclusion criteria (4 listed)
- All patients of both sexes.
- Aged from 18 to 70 years.
- Body Mass Index (BMI) from 25 to 35 kg/m2.
- Critically ill due to ARDS resulting from COVID-19 pneumonia.
Key exclusion criteria (4 listed)
- Patients who spent more than 24 hours on mechanical ventilators before enrolment in the study.
- Patients who died within the first 24 hours of presentation.
- Patients with advanced cancer.
- Pregnant patients.
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 POSITIONearly placed in prone positions within 24 hours of intubation | Other | Group A |
Primary outcome
Number of discharged patients
Time frame: 26 MONTHS
Number of discharged patients
3 secondary outcomes
The total length of stay
Time frame: 26 MONTHS
ICU length of stay
Time frame: 26 MONTHS
Patients who underwent tracheostomy procedures
Time frame: 26 MONTHS
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 1 Mar 2024.
- Individual participant dataSharing planned: Undecided. 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.
SAMEH H SEYAM, PHD study chair
Consultant critical care
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 Severe Acute Respiratory Syndrome, run by Zulekha Hospitals at 1 site in Egypt.
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 4 inclusion and 4 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 1 Mar 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 Egypt. 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?
Number of discharged patients (time frame: 26 MONTHS). 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 1 Mar 2024.