Non-Positive Pressure Ventilation in Hypoxemic Patients | NCT00925860

Studies
Non-Positive Pressure Ventilation in Hypoxemic Patients

NCT00925860

Sponsor

Hospital Provincial de Castellon

Status

Completed

Last Update Posted

Jun 22, 2009Estimated

Enrollment

64Actual

Phase

Phase 4

Conditions

Acute Respiratory Failure

Interventions

non positive pressure mechanical ventilatory support

Countries

Spain

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

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2007Actual

First Submitted Date

Jun 19, 2009

First Submission Date that Met QC Criteria

Jun 19, 2009

First Posted Date

Jun 22, 2009Estimated

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

Jun 19, 2009

Last Update Posted Date

Jun 22, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure.

Detailed Description

Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been randomized to be treated by conventional ventilatory support or non-positive mechanical ventilation support. Those patients who did not benefit from the experimental non-positive ventilatory support, were intubated and conventionally mechanically ventilated and discarded for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes were length of stay, improvement of oxygenation, and reduced complications rates.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non invasive ventilation approach	Experimental	pure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation	Procedure: non positive pressure mechanical ventilatory support
conventionally ventilated	No Intervention	pure hypoxemic patients treated by conventional ventilatory support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non positive pressure mechanical ventilatory support	Procedure		non invasive ventilation approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality rates		patient hospital discharge

Secondary Outcomes

Measure	Description	Time Frame
oxygenation improve		patient hospital discharge
diminishing of tracheal intubation incidence		patient hospital discharge
ICU and Post ICU hospital length of stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

dyspnea with respiratory rates higher than 35 p.m.
pO2 < 65 mmHg
paO2/FiO2 < 250

Exclusion Criteria:

respiratory or cardiac arrest
gastrointestinal bleeding
hemodynamic instability
face surgery
upper airway obstruction
inability for active cooperation
need for airway protection
exacerbation of COPD
decrease of conscious level
acute pulmonary cardiogenic oedema

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alberto Belenguer, MD	INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Department - General Hospital		Castelló	CASTELLO	12004	Spain