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CompletedNCT06287554proneUpdated Mar 1, 2024

Effect of Early Implementation of Prone Positioning

An observational study in Severe Acute Respiratory Syndrome, sponsored by Zulekha Hospitals. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-01.

Sponsored by Zulekha Hospitals · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
70
Ages
18 Years to 70 Years
Sex
All
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Study 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. 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.

02

Conditions studied

  • Severe Acute Respiratory Syndrome

Keywords

  • Prone, Lung protective, ARDS, APACHI II, SOFA
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In context

Severe Acute Respiratory Syndrome

382 studies on the registry are indexed under Severe Acute Respiratory Syndrome; 14 are open to participants now.

This study's enrollment of 70 is below the median of 300 across 140 observational studies indexed under Severe Acute Respiratory Syndrome.

Browse Severe Acute Respiratory Syndrome studies →

Lead sponsor

Zulekha Hospitals is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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,

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
70 participants (actual)
Target follow-up
26 Months
Patient registry
Yes

Groups and cohorts

  • Group A

    Group A (n:39) included patients who had been early placed in prone positions within 24 hours of intubation

    Other: PRONE POSITION

  • Group B

    Group B (n:31) included patients who had not been placed in prone position

Interventions

  • OtherPRONE POSITION

    early placed in prone positions within 24 hours of intubation

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What researchers measure

Primary outcomes

  1. Number of discharged patients

    Number of discharged patients

    Time frame: 26 MONTHS

Secondary outcomes

  1. The total length of stay

    The total length of stay

    Time frame: 26 MONTHS

  2. ICU length of stay

    ICU length of stay

    Time frame: 26 MONTHS

  3. Patients who underwent tracheostomy procedures

    Patients who underwent tracheostomy procedures

    Time frame: 26 MONTHS

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Study locations

1 site
  • Al-Azhar faculty of medicine
    Cairo, 12546, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided — undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06287554
Lead sponsor
Zulekha Hospitals
Collaborators
Al-Azhar University
Responsible party
Sponsor
First posted
Mar 1, 2024
Start date
Mar 4, 2020
Primary completion
Apr 20, 2022
Completion
Apr 20, 2022
Last update
Mar 1, 2024

Study contacts

SAMEH H SEYAM, PHD
study chair · Consultant critical care

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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