Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2?

NCT ID: NCT05109624

Last Updated: 2022-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-01-01

Brief Summary

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the aim of the study is to assess safety and efficacy of prone position ventilation beyond the usual 16 hrs in patients with SARS-COV-2

Detailed Description

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Conditions

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COVID-19 Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group(A) control group

pronation cycles each last for 16 hours every 24 hours

Group Type NO_INTERVENTION

No interventions assigned to this group

group(B)

pronation cycles each last for 24 hours followed by 6 hours supine position

Group Type ACTIVE_COMPARATOR

prolonged prone position ventilation

Intervention Type PROCEDURE

patients mechanically ventilated with SARS COV 2 will be subjected to a longer than usual period of prone position ventilation

Interventions

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prolonged prone position ventilation

patients mechanically ventilated with SARS COV 2 will be subjected to a longer than usual period of prone position ventilation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \- American Society of Anesthesiologists (ASA) physical status II- III.
* Sex (male and females).
* Age 18 -80 years.
* Sever adult respiratory distress (ARDS) (defined as a PaO2:FiO2 ratio of \<150 mm Hg, with a fraction of inspired oxygen (FiO2) of ≥0.6, a positive end expiratory pressure (PEEP) of ≥5 CmH2O, and a tidal volume of 6 ml/Kg of predicted body weight
* mechanical ventilation for less than 36 hours

Exclusion Criteria

* \- Contraindication for prone positioning

* increased intracranial tension.
* face trauma or surgery.
* Recent Deep venous thrombosis
* Unstable spine, femur, or pelvic fractures
* Mean arterial pressure \< 65 mm Hg
* Pregnant women
* Pneumothorax
* Prone positioning before inclusion
* Those returned to supine position before completing the session time
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Amr Fouad

lecturer of anesthesia and intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU R 160 / 2021

Identifier Type: -

Identifier Source: org_study_id

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