Prone Positioning in COVID-19 Patients

Not Applicable

• Conditions: Mechanical Ventilation Pressure High; Coronavirus Disease 2019; ARDS
• Interventions: Other: Oxygenation

• Registration Number: NCT05150847
• Lead Sponsor: Tepecik Training and Research Hospital

Brief Summary

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3).

The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6).

Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).

Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the recruitability position of the lung.in COVID-ARDS.

Detailed Description

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3).

The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6).

Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the oxygenation, respiratory mechanics and recruitability position of the lung in COVID-ARDS.

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-09
• Study Start: 2021-12-25
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Primary Completion: 2022-02-01
• Last Update Posted: 2022-02-01
• Study Completion: 2022-04-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult patients with laboratory-confirmed COVID-19 admitted to the ICU
• The patients receive invasive mechanical ventilation and meet the criteria for ARDS (Berlin definition) (8), with under continuous infusion of sedatives,

Exclusion Criteria

• Pregnancy
• Pneumothorax and or chest tube
• Chronic obstructive lung disease
• interstitial lung disease
• intraabdominal hypertension
• increase in intracranial blood pressure
• Haemodynamic unstability requiring vasopressors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prone Positioning	Oxygenation	Patients will be ventilated in volume-controlled mode with Vt at 6 ml/kg of predicted body weight. Prone positioning will be performed over periods of 16 hours when PaO2/FiO2 was persistently lower than 150 mm Hg. Flow, volume, and airway pressure will bw measured by ventilators. Measurements of oxygenation and respiratory mechanics were performed at 5 and 15 cmH20 PEEP levels and will be repeated every season as before first period of prone positioning, before supine positioning, and again before second period of prone positioning. Total PEEP and plateau pressure will be measured by a short end-expiratory and an end-inspiratory occlusion respectively. Complete airway closure will be assessed by performing a low-flow (4 L/min) inflation( PV tool) (9). The potential for lung recruitment will be assessed by means of the R/I ratio (10).

Primary Outcome Measures

Name	Time	Method
Oxygenation	intubation + 48 hours	PaO2/FiO2

Secondary Outcome Measures

Name	Time	Method
Recruitability	intubation + 48 hours	recruitment to inflation ratio
Static compliance	intubation + 48 hours	Tidal volume divided driving pressure

Trial Locations

Locations (1)

Kazim Rollas; 🇹🇷 İzmir, Turkey