NCT04641182

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

September 12, 2020

Last Update Submit

November 20, 2020

Conditions

Covid19ArdsRespiratory Failure

Outcome Measures

Primary Outcomes (7)

  • Therapeutic failure

    Defined by death or intubation or use of non-invasive ventilation

    At 14 days

  • Mortality

    Number of patients that die

    At day 28

  • Length of hospital stay

    Number of days spent by the patients at the hospital

    At 28 days

  • Days requiring high flow nasal oxygen

    Number of days the patients require high flow nasal oxygen therapy

    At 28 days

  • Days requiring supplemental oxygen

    Number of days the patients require supplementary oxygen

    At 28 days

  • Displacement of invasive devices during position changes

    Unintentional displacement or removal of Invasive devices including : central and peripheric vascular catheters, urinary catheter and chest tubes

    At 28 days

  • Occurrence of pressure ulcers on the anterior surface of the body

    Number of patients that develope pressure ulcers on the anterior surface of the body

    At 28 days

Secondary Outcomes (4)

  • Respiratory superinfection

    At 28 days

  • Delirium

    At 28 days

  • Caloric intake

    At 28 days

  • Proteic intake

    At 28 days

Other Outcomes (4)

  • Dyspnea

    At 28 days

  • Comfort with the position

    At 28 days

  • Oxygen saturation

    At 28 days

  • +1 more other outcomes

Study Arms (2)

Prone position

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

Other: Prone position

No prone position

The control group will not be in prone position

Interventions

Prone positionOTHER

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

Prone position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized COVID-19 adult patients with acute respiratory failure

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Red de Salud UC - Christus

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

COVID-19Acute Lung InjuryRespiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesLung InjuryRespiration Disorders

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2020

First Posted

November 23, 2020

Study Start

July 6, 2020

Primary Completion

August 16, 2020

Study Completion

September 16, 2020

Last Updated

November 23, 2020

Record last verified: 2020-11

Locations

CL(1)