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Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure

NCT ID: NCT04641182

Last Updated: 2020-11-23

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

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-06

Study Completion Date

2020-09-16

Brief Summary

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The aim of this observational study is to evaluate the physiological and clinical effects of prone position in awake patients with respiratory failure due to COVID-19.

Detailed Description

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The purpose of this study is to investigate the role of prone positioning in SARS-CoV-2 infected patients that are not intubated. Prone patient placement during invasive mechanical ventilation is a widespread practice in the management of severe ARDS. However, few attempts have been made to implement the prone position in patients that spontaneously ventilate with supplemental oxygen. Considering that it is a procedure that does not require additional equipment and does not represent an additional cost for its implementation, it becomes a valuable tool in the context of COVID-19 where intubation is associated with high mortality. The investigators will analyze a cohort of patients with COVID-19 and respiratory failure managed with prone position as indicated by the attending physician and register physiological variables and clinical outcomes (intubation and death).

Conditions

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Covid19 Ards Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prone position

Prone position per institutional protocol and as indicated by the treating physician

Prone position

Intervention Type OTHER

Prone position as indicated by the treating physician as specified in the institutional protocol

No prone position

The control group will not be in prone position

No interventions assigned to this group

Interventions

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Prone position

Prone position as indicated by the treating physician as specified in the institutional protocol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients with confirmed or suspected COVID-19 pneumonia requiring more than 3 liters per minute of supplemental oxygen or a Fraction of Inspired Oxygen (FIO2) over 35% to keep Pulse Oximetry Saturation (SpO2) over 90%
* Treating physician indicated prone position as instructed by the institutional protocol
* Patient capable of changing position with minimal help from the personnel

Exclusion Criteria

* Patient requiring immediate intubation
* Patient requiring non-invasive mechanical ventilation
* Respiratory Rate \> 40, signs of respiratory fatigue or unconsciousness with inability to protect the airway
* PaCO2 \> 50mmHg
* Hemodynamic instability (defined by Heart Rate \> 120, Systolic Pressure \< 90mmHg, Mean Arterial Pressure \< 60mmHg or requiring vasopressor support)
* Obesity with BMI \> 40 (Body Mass Index: weight in kilograms and height in meters will be combined to attain BMI in kg/m2)
* Persistent vomiting
* Facial or thoracic trauma or recent surgery contraindicating the prone position
* Pregnancy \> 20 weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clinico Red de Salud UC - Christus

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id