search
Back to results

Non-Positive Pressure Ventilation in Hypoxemic Patients

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
non positive pressure mechanical ventilatory support
Sponsored by
Hospital Provincial de Castellon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intensive Care Department - General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

non invasive ventilation approach

conventionally ventilated

Arm Description

pure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation

pure hypoxemic patients treated by conventional ventilatory support

Outcomes

Primary Outcome Measures

mortality rates

Secondary Outcome Measures

oxygenation improve
diminishing of tracheal intubation incidence
ICU and Post ICU hospital length of stay

Full Information

First Posted
June 19, 2009
Last Updated
June 19, 2009
Sponsor
Hospital Provincial de Castellon
search

1. Study Identification

Unique Protocol Identification Number
NCT00925860
Brief Title
Non-Positive Pressure Ventilation in Hypoxemic Patients
Official Title
Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Provincial de Castellon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non invasive ventilation approach
Arm Type
Experimental
Arm Description
pure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation
Arm Title
conventionally ventilated
Arm Type
No Intervention
Arm Description
pure hypoxemic patients treated by conventional ventilatory support
Intervention Type
Procedure
Intervention Name(s)
non positive pressure mechanical ventilatory support
Primary Outcome Measure Information:
Title
mortality rates
Time Frame
patient hospital discharge
Secondary Outcome Measure Information:
Title
oxygenation improve
Time Frame
patient hospital discharge
Title
diminishing of tracheal intubation incidence
Time Frame
patient hospital discharge
Title
ICU and Post ICU hospital length of stay
Time Frame
patient hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Belenguer, MD
Organizational Affiliation
INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Department - General Hospital
City
Castello
ZIP/Postal Code
12004
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Non-Positive Pressure Ventilation in Hypoxemic Patients

We'll reach out to this number within 24 hrs