PRONELIFE is the first randomized controlled trial comparing the prone position with the supine position in patients with acute hypoxemic respiratory failure from any cause that recruits a sufficient number of patients to test the hypothesis that…
ID
Source
Brief title
Condition
- Other condition
- Thoracic disorders (excl lung and pleura)
Synonym
Health condition
buikligging ter voorkoming van beademing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the number of ventilator-free days at 14 days.
Secondary outcome
Secondary endpoints include the effects of prone position upon oxygenation,
dyspnea, weaning from a respiratory support device, ICU and hospital length of
stay, and mortality at days 28 and 90.
Background summary
It is uncertain whether the prone position in patients with spontaneous
breathing and acute hypoxemic respiratory failure avoids the need for invasive
mechanical ventilation. Lung-protective mechanical ventilation with low tidal
volumes remains the mainstay management strategy for acute respiratory failure
patients and acute respiratory distress syndrome (ARDS). Mechanical ventilation
has several detrimental side-effects contributing to morbidity and mortality .
Furthermore, tracheal intubation is usually associated with the need for
sedation and/or neuromuscular blockade. This precludes mobilization, promotes
muscular deconditioning, and potentially contributes to critical illness's
long-term cognitive sequelae.
Study objective
PRONELIFE is the first randomized controlled trial comparing the prone position
with the supine position in patients with acute hypoxemic respiratory failure
from any cause that recruits a sufficient number of patients to test the
hypothesis that the prone position strategy benefits patients with spontaneous
breathing and acute respiratory failure concerning a clinically relevant
endpoint.
Study design
PRONELIFE is an international multicenter randomized controlled trial in
spontaneous breathing patients with acute hypoxemic respiratory failure from
any etiology admitted to the ICU. Consecutive patients will be randomly
assigned to standard treatment with prone position strategy or standard therapy
in the supine position
Intervention
prone position
Study burden and risks
nihil
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
18 year and older
acute respiratory failure
Exclusion criteria
no informed consent
prone position impossible
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN11536318 |
| CCMO | NL79592.100.21 |