NCT05109624

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

November 3, 2021

Last Update Submit

February 16, 2022

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

  • rate of successful weaning

    how many patients successfully extubated, hospital survival, ICU stay

    28 days

  • Incidence of complications

    Incidence of facial edema, pressure wounds, lines disconnections, hemodynamic instability

    28 days

Secondary Outcomes (1)

  • Efficacy of oxygenation

    28 days

Study Arms (2)

group(A) control group

NO INTERVENTION

pronation cycles each last for 16 hours every 24 hours

group(B)

ACTIVE COMPARATOR

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

Procedure: prolonged prone position ventilation

Interventions

prolonged prone position ventilationPROCEDURE

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

group(B)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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
  • Those returned to supine position before completing the session time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and intensive care

Study Record Dates

First Submitted

November 3, 2021

First Posted

November 5, 2021

Study Start

October 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

February 17, 2022

Record last verified: 2022-02

Locations

EG(1)