Early prone position in patients on spontaneous ventilation

Early prone position in spontaneous ventilation patients with respiratory failure secondary to COVID-19: randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-7d7ngw

Enrollment

Unknown

Registered

2020-08-07

Start date

2020-07-15

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency

Interventions

44 participants will be included in group G1 where, in addition to the usual care, they will be submitted to an early prone position three times a day, every 6 hours, for periods of 2 consecutive hour

Procedure/surgery

G11.427.695.525

Eligibility

Inclusion criteria

Inclusion criteria: Patients will be included in surveys over the age of 18; are available hemodynamically; with arterial oxygen saturation greater than or equal to 94%; temperature below 38.5 degrees; Respiratory rate below 30 breaths per minute; who are on spontaneous ventilation to the environment or using oxygen support.

Exclusion criteria

Exclusion criteria: Patients who do not have a confirmed diagnosis of COVID-19 will be excluded; patients with severe acute arrhythmias; with a history of hemodynamic instability or recent cardiorespiratory arrest; Recent cardiothoracic surgery or unstable chest; Polytrauma with unstabilized fractures; Pregnant women; Recent abdominal surgery or stoma formation.

Design outcomes

Primary

Measure	Time frame
Reduction of the need for orotracheal intubation and invasive mechanical ventilation in patients submitted to early prone position, verified by measuring epidemiological variables such as relative risk, absolute risk and the number needed to treat, based on the finding of a difference of at least 10 per between groups.;Fewer deaths in patients submitted to early prone position, verified by measuring epidemiological variables such as relative risk, absolute risk and the number needed to treat, based on the observation of a difference of at least 10 percent between the groups.	—

Measure

Time frame

Reduction of the need for orotracheal intubation and invasive mechanical ventilation in patients submitted to early prone position, verified by measuring epidemiological variables such as relative risk, absolute risk and the number needed to treat, based on the finding of a difference of at least 10 per between groups.;Fewer deaths in patients submitted to early prone position, verified by measuring epidemiological variables such as relative risk, absolute risk and the number needed to treat, based on the observation of a difference of at least 10 percent between the groups.

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Secondary

Measure	Time frame
Intervention group patients will use lower levels of oxygen therapy ;The hospital stay will be shorter than the control group.;The patients in the intervention group will show better respiratory performance, assessed by improving respiratory rate, reducing levels of perception of dyspnea through the measurement of the Modified BORG Scale.;The patients in the intervention group will present optimization of gas exchange by measuring arterial oxygen saturation.	—

Measure

Time frame

Intervention group patients will use lower levels of oxygen therapy ;The hospital stay will be shorter than the control group.;The patients in the intervention group will show better respiratory performance, assessed by improving respiratory rate, reducing levels of perception of dyspnea through the measurement of the Modified BORG Scale.;The patients in the intervention group will present optimization of gas exchange by measuring arterial oxygen saturation.

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Countries

Brazil

Contacts

Public ContactJorge Luis Dos Anjos

Hospital Geral Roberto Santos

jorgelmanjos@hotmail.com+5507131177519

Outcome results

None listed

Source: REBEC (via WHO ICTRP)