Prone Positioning in COVID-19 Patients

Sponsor
Tepecik Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05150847
Collaborator
(none)
50
1
1
3.6
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Oxygenation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
The Effect of Prone Positioning on Oxygenation and Respiratory Mechanics in Patients With COVID-19 Pneumonia
Actual Study Start Date :
Dec 25, 2021
Actual Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Apr 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Prone Positioning

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).

Other: Oxygenation
Oxygenation will be calculated as PaO2/ FiO2 ratio.Static compliance will be calculated as tidal volume divided driving pressure.The potential for lung recruitment will be assessed by means of the R/I ratio (10).
Other Names:
  • static compliance, Recruitability
  • Outcome Measures

    Primary Outcome Measures

    1. Oxygenation [intubation + 48 hours]

      PaO2/FiO2

    Secondary Outcome Measures

    1. Static compliance [intubation + 48 hours]

      Tidal volume divided driving pressure

    2. Recruitability [intubation + 48 hours]

      recruitment to inflation ratio

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kazim Rollas İzmir Turkey 55327

    Sponsors and Collaborators

    • Tepecik Training and Research Hospital

    Investigators

    • Study Chair: Işıl Köse Güldoğan, İzmi̇r Tepeci̇k Eği̇ti̇m Ve Arştırma Hastanesi̇

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kazim Rollas, Intensive Care Specialist, Principal Investigator, Tepecik Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05150847
    Other Study ID Numbers:
    • 2021/11-02
    First Posted:
    Dec 9, 2021
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 1, 2022