Awake Pronation for Covid-19 Treatment

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-16

Study Completion Date

2021-07-01

Brief Summary

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

Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.

None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion

Related Clinical Trials

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

Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support

NCT04649658

Covid19

COMPLETED

The Prone Position in Covid-19 Affected Patients

NCT04365959

Sars-CoV2

COMPLETED

Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure

NCT05866289

Survival, Prosthesis Oxygen Deficiency

COMPLETED

Awake Prone Position in Patients With COVID-19

NCT04924816

Covid19

COMPLETED

Non-ventilated Prone Positioning in the COVID-19 Population

NCT05957588

COVID-19 Proning Oxygenation +1 more

COMPLETED NA

Detailed Description

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

Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.

These studies were mainly physiological and reported in a subset of patients a poor tolerance. Indeed most of the beneficial effects on gas exchage disappeared in around 40% of tyhe patients, once the patients regained the supine position.

None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion.

This holds particularly true in those patients affected by mild de-novo ARF (PaO2/FiO2 ratio within the range of 200-300), where any form of respiratory support like Continuous Positive Airways Pressure (CPAP), High Flow Nasal Cannula (HFNC) or Noninvasive ventilation (NIV), may be not yet indicated, especially if the patients are admitted to a regular ward as for the case of Covid-19 pandemics, due to the lack of "protected" beds.

Conditions

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

Covid-19 Infection

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

randomised trial

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.

Oxygen and Prone Position (PP)

Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96% plus PP for a minimum of 10 hrs a day

Group Type EXPERIMENTAL

Prone Position (PP)

Intervention Type PROCEDURE

Prone the patients on oxygen for at least 10 hrs a day

Oxygen

Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96%

Group Type ACTIVE_COMPARATOR

Prone Position (PP)

Intervention Type PROCEDURE

Prone the patients on oxygen for at least 10 hrs a day

Interventions

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

Prone Position (PP)

Prone the patients on oxygen for at least 10 hrs a day

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* confirmed COVID-19 infection using PCR
* Acute Respiratory Failure ( 200 \<PaO2/FiO2 \<300) and respiratory rate \< 30 atti/min
* O2 therapy initiated \<72 hrs
* informed consent

Exclusion Criteria

* Glasgow Coma Scale (GCS) \< 13
* pH\< 7,45, PaCO2 \>45 mmHg
* need for HFNC, CPAP, NIV or intubation
* hemodynamic instability increase of 80-90 mmHg or reduction of 30-40 mmHg in systolic blood pressure
* severe arrythmia of myocardial infarction
* need for sedation
* intolerance to PP
* pregnancy
* Body mass index (BMI) \> 35 kg/m2.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No