Skip to main content
OpenTrials
Completed

NCT Number: NCT00925860

Non-Positive Pressure Ventilation in Hypoxemic Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Respiratory Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intensive Care Department - General Hospital

Castelló, CASTELLO, 12004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non positive pressure mechanical ventilatory support

Procedure

Primary outcomes

  1. mortality rates

    Time frame: patient hospital discharge

Secondary outcomes

  1. oxygenation improve

    Time frame: patient hospital discharge

  2. diminishing of tracheal intubation incidence

    Time frame: patient hospital discharge

  3. ICU and Post ICU hospital length of stay

    Time frame: patient hospital discharge

Sponsors and collaborators

Lead sponsor

Hospital Provincial de Castellon

Other

Registry information

Official study title

Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study

Important dates

Study start
2001
Primary completion
2006
Study completion
2007
First posted
Jun 22, 2009
Registry last updated
Jun 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.