NCT04361435

Lung Recruitment Device for COVID-19

Status unknown NA Last updated 28 April 2020

What this trial tests

NA trial testing Chest physiotherapy using a non-invasive oscillating device in COVID-19 in 50 participants. Status unknown.

Timeline

1 May 2020

Primary endpoint
31 July 2020

31 December 2020

Quick facts

Lead sponsor	St. Justine's Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	supportive care
Enrollment	50
Start date	1 May 2020
Primary completion	31 July 2020
Estimated completion	31 December 2020

Drugs / interventions tested

• Chest physiotherapy using a non-invasive oscillating device

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• Physiotherapy — all drugs for Physiotherapy →

Sponsor

St. Justine's Hospital

Who can join

Eligibility, any sex, with COVID-19 or Physiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

INTRODUCTION As there is no specific cure in the treatment of COVID-19 at this moment of the pandemic, supportive management including mechanical ventilation is the core management in an intensive care unit (ICU). It is a challenge to provide consistent care in this situation of high demand and potential staff shortage in ICU. Also, the investigators need to reduce unnecessary exposure of the providers to the virus. This study aims to examine the impact of care using a non-invasive oscillating device (NIOD) for chest physiotherapy in the care of mechanically ventilated patients with COVID-19.

METHODS Objective: To explore if a NIOD performed by non-specialized personnel is not inferior to the standard Chest PhysioTherapy (CPT) in the care of COVID-19.

Design: A Pilot Multicenter Prospective Crossover Randomized Study. Setting: Two ICUs in Canadian Academic Hospitals (CHU Sainte Justine and Montreal General Hospital) Patients: All the mechanically ventilated patients admitted to the two ICUs, and CPT ordered by the responsible physician, with COVID-19 infection during the study period.

Procedure: The investigators will implement NIOD and CPT alternatingly for 3 hours apart over 3 hours. We will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, Intermittent Positive Pressure Ventilation (IPPV), suctioning (e.g., oral or nasal), or changing the ventilator settings or modality can be provided at the direction of bedside intensivists in charge. The order of the procedures (i.e. NIOD or CPT) will be randomly allocated.

Measurements and Analyses: The primary outcome measure is the oxygenation level before and after the procedure (SpO2/FIO2 (SF) ratio). For the cases with Invasive ventilation and non-invasive ventilation, the investigators will also document expiratory tidal volume, vital signs, and any related complications such as vomiting, desaturations, or unexpected extubations. The investigators will collect the data before, 10 minutes after, and 30 minutes after the procedure.

Sample Size: The investigators estimate the necessary sample size as 25 for each arm (Total 50 cases), with a power of 0.90, alfa of 0.05, with the non-inferiority design.

FUTURE CONSIDERATIONS This randomized pilot study will be considered a running phase if the investigators can/should undertake the RCT which should follow without significant modification of the methods.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial.
   Kawaguchi A, Bernier G, Lacroix J, El Salti S, et al · · 2020 · PMID 32620174 · DOI 10.1186/s13063-020-04533-6