Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support (PRINCESS)

Awake Prone Position in Critical and Severe COVID-19 Patients Undergoing Noninvasive Respiratory Support: a Retrospective Multicenter Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Behavioral: Prone position

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy
    • Azienda Ospedaliero Universitaria Policlinico di Modena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

Inclusion Criteria

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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prone position; Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to prone position	Behavioral: Prone position; Prone position maintained at least 3 hours/day
Standard care; Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endotracheal intubation	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	28 days
Tracheostomy	28 days
Length of Respiratory Intensive Care Unit stay	60 days
Length of Hospital stay	60 days

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Respiratory failure; Spontaneous breathing; Awake pronation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: UModenaReggio10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No