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OpenTrials
Completed

NCT Number: NCT04649658

Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prone position

Behavioral

Prone position maintained at least 3 hours/day

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

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Official study title

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

Acronym: PRINCESS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2020
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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