COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality.

Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)

NCT04350723

Corona Virus Infection Covid19 COVID-19

COMPLETED NA

HFNC and Prone Positioning in Awake Patients With Severe COVID-19

NCT04982341

Hypoxemic Respiratory Failure

COMPLETED

Prone Position in Patients on High-flow Nasal Oxygen Therapy for COVID-19 (HIGH-PRONE-COVID-19)

NCT04358939

Acute Respiratory Distress Syndrome COVID-19

COMPLETED NA

High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period

NCT03121482

Acute Respiratory Failure Requiring Reintubation

COMPLETED NA

CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals

NCT04402879

Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19 Acute Respiratory Distress Syndrome +2 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronavirus Infection COVID Severe Acute Respiratory Syndrome Respiratory Failure Respiratory Insufficiency Respiratory Distress Syndrome ARDS Lung Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Awake prone positioning

Prone positioning of patients on nasal high-flow oxygen therapy

Group Type EXPERIMENTAL

Awake Prone Positioning

Intervention Type PROCEDURE

Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h

Standard care

Standard decubitus positioning of patients on nasal high-flow oxygen therapy

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type PROCEDURE

Patients will not receive any special instructions with regards to proning.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Awake Prone Positioning

Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h

Intervention Type PROCEDURE

Standard care

Patients will not receive any special instructions with regards to proning.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* COVID-19, either confirmed by SARS-CoV-2 assay, or clinically suspected, with results of the assay pending;
* Lung infiltrates documented on chest X-ray or chest CT-scan;
* Significant respiratory distress that requires treatment with HFNO.

Exclusion Criteria

* Unable to consent;
* Unable to prone;
* Indication for immediate endotracheal intubation and mechanical ventilation;
* Contraindication to prone positioning (severe obesity, abdominal wound, pregnancy, unstable pelvic/spinal lesions, vomiting, etc.);
* Comfort care or imminent expectation of death.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No