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CompletedNCT04649658PRINCESSUpdated Dec 14, 2020

Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support

An observational study in Covid19, sponsored by University of Modena and Reggio Emilia. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-14.

Sponsored by University of Modena and Reggio Emilia · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
93
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Covid19

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Keywords

  • Spontaneous breathing
  • Awake pronation
  • COVID-19
  • Respiratory failure
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 93 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of Modena and Reggio Emilia is the lead sponsor of 61 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

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).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
93 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralProne position

    Prone position maintained at least 3 hours/day

06

What researchers measure

Primary outcomes

  1. Endotracheal intubation

    Time frame: 28 days

Secondary outcomes

  1. Mortality

    Time frame: 28 days

  2. Tracheostomy

    Time frame: 28 days

  3. Length of Respiratory Intensive Care Unit stay

    Time frame: 60 days

  4. Length of Hospital stay

    Time frame: 60 days

07

Study locations

1 site
  • Azienda Ospedaliero Universitaria Policlinico di Modena
    Modena, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04649658
Lead sponsor
University of Modena and Reggio Emilia
Responsible party
Roberto Tonelli (MD, University of Modena and Reggio Emilia) — Principal investigator
First posted
Dec 2, 2020
Start date
Mar 1, 2020
Primary completion
Jun 1, 2020
Completion
Nov 30, 2020
Last update
Dec 14, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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