NCT00526981

Brief Summary

The study will test the hypothesis that the prone position can be used to reduce the need for intubation and mechanical ventilation in patients with acute respiratory failure.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

4.3 years

First QC Date

September 6, 2007

Last Update Submit

September 19, 2011

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Need for intubation and mechanical ventilation

    Duration of hospital stay

Study Arms (2)

Treatment

EXPERIMENTAL

Prone position + all conventional treatment.

Other: Prone position

Control

NO INTERVENTION

Conventional treatment

Interventions

Prone positionOTHER

Prone position during spontaneous breathing.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bilateral pulmonary infiltrates or unilateral infiltrates involving more than one lobe on CXR
  • PaO2/FIO2 \< 40 kPa
  • RR \> 25, or attending intensivist considering likelihood of intubation \> 50%

You may not qualify if:

  • unsuited for the prone position
  • immunosuppression
  • chronic lung disease
  • decision of withdrawal or limitation of therapy
  • pulmonary infiltrates of cardiac origin
  • decreased GCS level
  • PaCO2 \> 10
  • attending intensivist considering the patient unsuited for the prone position
  • BMI \> 33

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital Solna

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Johan Petersson, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Petersson, MD

CONTACT

+4685172066johan.petersson@karolinska.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2011

Last Updated

September 20, 2011

Record last verified: 2011-09

Locations

SE(1)