Effect of Early Implementation of Prone Positioning | NCT06287554

Studies
Effect of Early Implementation of Prone Positioning

NCT06287554

Sponsor

Zulekha Hospitals

Status

Completed

Last Update Posted

Mar 1, 2024Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Severe Acute Respiratory Syndrome

Interventions

PRONE POSITION

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2020Actual

Primary Completion Date

Apr 20, 2022Actual

Completion Date

Apr 20, 2022Actual

First Submitted Date

Feb 23, 2024

First Submission Date that Met QC Criteria

Feb 29, 2024

First Posted Date

Mar 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 29, 2024

Last Update Posted Date

Mar 1, 2024Actual

Name	Class
Al-Azhar University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

26 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PRONE POSITION	Other	early placed in prone positions within 24 hours of intubation	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of discharged patients	Number of discharged patients	26 MONTHS

Secondary Outcomes

Measure	Description	Time Frame
The total length of stay	The total length of stay	26 MONTHS
ICU length of stay	ICU length of stay	26 MONTHS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder 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,

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
SAMEH H SEYAM, PHD	Consultant critical care	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Azhar faculty of medicine		Cairo		12546	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D045169	Severe Acute Respiratory Syndrome

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D018352	Coronavirus Infections
D003333	Coronaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016684	Prone Position

Ancestor Terms

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided