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

Ain Shams University

Status: Completed

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Treatments: Procedure: prolonged prone position ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05109624

FMASU R 160 / 2021

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

group(A) control group

No Intervention group

Description:

pronation cycles each last for 16 hours every 24 hours

group(B)

Active Comparator group

Description:

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

Treatment:

Procedure: prolonged prone position ventilation