Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support

NCT04649658 | Completed

• 1 other identifier: UModenaReggio10
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Pronation seems feasible and effective in improving blood oxygenation in patients with COVID-19 pneumonia. Data are lacking on the effects of pronation on clinical outcome in this subset of patients.

Conditions

Covid19

Keywords

Spontaneous breathing; Awake pronation; COVID-19; Respiratory failure

Outcome Measures

Primary Outcomes (1)

• Endotracheal intubation

  28 days

Secondary Outcomes (4)

• Mortality

  28 days

• Tracheostomy

  28 days

• Length of Respiratory Intensive Care Unit stay

  60 days

• Length of Hospital stay

  60 days

Study Arms (2)

Prone position

Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to prone position

Behavioral: Prone position

Standard care

Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to standard care

Interventions

Prone position BEHAVIORAL

Prone position maintained at least 3 hours/day

Prone position

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients aged ≥18 and \< 80 years old admitted to the two respiratory intensive care units for severe and critical COVID-19 pneumonia between March 1st, 2020 and June 1st, 2020.

You may qualify if:

• patients aged ≥18 and \< 80 years old
• acute respiratory failure

You may not qualify if:

• endotracheal intubation performed within the first 24 hours from admission,
• ceiling of escalation of intensive care
• do not intubate order as expressed by patient willing or upon clinical judgement
• missing core data at medical record analysis (clinical features at baseline, pronation information, type and time of ventilatory support required, mortality, need for tracheostomy, length of respiratory intensive care unit and hospital stay).

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Italy

Location

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 2, 2020
• Study Start: March 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: November 30, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)