Prone Position for Non-intubated Patients With Acute Resp... | NCT00526981

Studies
Prone Position for Non-intubated Patients With Acute Respiratory Failure

NCT00526981

Sponsor

Karolinska University Hospital

Status

Unknown status

Last Update Posted

Sep 20, 2011Estimated

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Respiratory Failure

Interventions

Prone position

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Dec 2011Estimated

Completion Date

Not provided

First Submitted Date

Sep 6, 2007

First Submission Date that Met QC Criteria

Sep 6, 2007

First Posted Date

Sep 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2011

Last Update Posted Date

Sep 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Prone position + all conventional treatment.	Other: Prone position
Control	No Intervention	Conventional treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prone position	Other	Prone position during spontaneous breathing.	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Need for intubation and mechanical ventilation		Duration of hospital stay

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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%

Exclusion Criteria:

unsuited for the prone position
fulfilled inclusion criteria for more than 5 days (120 h)
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Johan Petersson, MD	Contact	+4685172066		johan.petersson@karolinska.se

Overall Officials

Name	Affiliation	Role
Johan Petersson, MD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital Solna	Recruiting	Stockholm		17176	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016684	Prone Position

Ancestor Terms

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided