NCT00925860

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2001

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

Enrollment Period

5 years

First QC Date

June 19, 2009

Last Update Submit

June 19, 2009

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • mortality rates

    patient hospital discharge

Secondary Outcomes (3)

  • oxygenation improve

    patient hospital discharge

  • diminishing of tracheal intubation incidence

    patient hospital discharge

  • ICU and Post ICU hospital length of stay

    patient hospital discharge

Study Arms (2)

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

non positive pressure mechanical ventilatory supportPROCEDURE
non invasive ventilation approach

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Department - General Hospital

Castelló, CASTELLO, 12004, Spain

Location

Study Officials

  • Alberto Belenguer, MD

    INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 22, 2009

Study Start

June 1, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2007

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

ES(1)