Timed Awake Prone and Repositioning for Patients With Covid-19-induced Hypoxic Respiratory Failure.

January 14, 2023 updated by: Min Yan, Second Affiliated Hospital, School of Medicine, Zhejiang University

Efficacy of Timed Awake Prone and Repositioning in Patients With Covid-19-induced Hypoxic Respiratory Failure: a Multi-center, Randomized Controlled Trial.

Awake prone positioning has been reported to improve oxygenation for patients with COVID-19. Awake timed and repositioning is a novel method to improve patients' compliance and prolong the prone time. This study aims to explore the impact of timed prone and repositioning on the intubation rate and prognosis of COVID-19 patients with hypoxic respiratory failure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with COVID-19 may develop severe illness characterized by progressive hypoxic respiratory failure, resulting in the need for invasive mechanical ventilation. Reducing the rate of endotracheal intubation in patients with hypoxic respiratory failure can be beneficial to the prognosis, economize iatrical resources and reduce sanitary investment. Some studies have shown that prone positioning can improve oxygenation to some extent in patients receiving invasive mechanical ventilation due to severe ARDS.

Whether awake prone positioning can reduce endotracheal intubation and mortality in COVID-19 patients with hypoxic respiratory failure is still controversial. A meta-analysis found that the awake prone positioning was safe and feasible to reduce the risk of intubation or death. However, the multicenter randomized controlled trial (RCT) conducted by Alhazzani et al pointed out that the awake prone positioning group did not significantly reduce the rate of endotracheal intubation when compared with the standard of care.

Some researchers thought the time of prone positioning is an important factor for the different results. In previous studies, the median duration of prone positioning was only 4.8-5 hours per day but some guidelines recommend the duration should be more than 8 hours. Therefore, increasing patient adherence in the awake prone positioning and extending prone positioning time are of great importance.

Awake timed prone and repositioning is a novel method proposed in recent years, which can improve patients' compliance and prolong the time of treatment. This study intends to ask whether awake timed prone and repositioning could impact the intubation rate and prognosis of unincubated patients with hypoxic respiratory failure induced by COVID-19.

Study Type

Interventional

Enrollment (Anticipated)

286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Changxing, Zhejiang, China, 313199
        • Changxing People's Hospital
        • Contact:
          • jingfen Jin
          • Phone Number: +86-13757118239
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Lishui, Zhejiang, China, 323020
        • Lishui Municipal Central Hospital
        • Contact:
          • Meifen Chen, Doctor
          • Phone Number: +86-13567618608

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults ≥ 18 years of age
  • Awake patients without endotracheal intubation
  • Suspected or confirmed infection of COVID-19
  • Hypoxemia requiring oxygen supplementation ≥ 0.4 FiO2 or ≥ 5L/min via nasal cannula
  • Bilateral or unilateral chest infiltrates on x-ray or HRCT
  • Admitted to the ICU or an acute care unit where hemodynamic and respiratory
  • Willingness to comply with the protocol and provide written informed consent

Exclusion Criteria:

  • Risk of airway obstruction or even asphyxia
  • Need for emergent intubation after admission
  • Respiratory failure caused by cardiogenic pulmonary edema
  • Unable to implement timed prone and repositioning due to any cause
  • Injury or wound on the ventral body surface affecting the prone position
  • Unstable fracture of cervical vertebra and spine
  • Glaucoma or other sharp increases in intraocular pressure
  • Intracranial hypertension caused by traumatic brain injury etc.
  • Significantly high risk of pulmonary embolism
  • Acute hemorrhagic disease
  • Respiratory rate >40 breaths/min, with significant dyspnea
  • Transcutaneous oxygen saturation can not be continuously monitored
  • Hemodynamic instability requiring vasoactive drugs (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg despite adequate volume resuscitation)
  • Awareness disorder or inability to accept instructions, communication barrier with the nursing team, inability to use language or pager to call for help
  • Difficulty or limitation in autonomous movement, inability to adjust the position without assistance from others
  • Body mass index > 37 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Awake timed prone and repositioning group
Patients' cumulative prone and repositioning time is encouraged to reach 8-10 hours per day for 4 days following a timed prone and repositioning strategy.
Behavioral: Awake timed prone and repositioning

Patients were instructed to adopt a timed prone and repositioning strategy with 4 sessions for four consecutive days.

Session 1, lying on the belly; Session 2, lying on the right side; Session 3, sitting up; Session 4, lying on the left side; then back to session 1 (30 minutes to two hours for each session). The daily duration of timed prone and repositioning is strongly recommended for 8-10 hours.
No Intervention: Standard care group
Patients can change their positions freely according to their own needs. Health providers do not take the initiative to give guidance on prone and repositioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endotracheal Intubation rate
Time Frame: Day 30
The incidence of endotracheal Intubation within 30 days of study enrollment
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Day 30
All-cause death within 30 days of study enrollment
Day 30
Days of non-invasive ventilation
Time Frame: Day 30
Number of days alive and free of mechanical ventilation within 30 days of study enrollment
Day 30
Days alive and outside the ICU
Time Frame: Day 30
Number of days alive and outside the ICU within 30 days of study enrollment
Day 30
Clinical events
Time Frame: Day 30
Clinical events include time to treatment failure( treatment failure defined as intubation or death); time to intubation; time to death; duration of invasive mechanical ventilation in intubated patients surviving to day 30; mortality in invasively mechanically ventilated patients; and physiological response to awake prone positioning, including the ratio of SpO2:FiO2 to respiratory rate, known as the ROX index.
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Min Yan, M.D., Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 18, 2023

Primary Completion (Anticipated)

February 18, 2024

Study Completion (Anticipated)

February 18, 2024

Study Registration Dates

First Submitted

January 14, 2023

First Submitted That Met QC Criteria

January 14, 2023

First Posted (Estimate)

January 19, 2023

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 14, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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