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Non-Positive Pressure Ventilation in Hypoxemic Patients

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00925860
Enrollment
64
Registered
2009-06-22
Start date
2001-06-30
Completion date
2007-06-30
Last updated
2009-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

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.

Interventions

PROCEDUREnon positive pressure mechanical ventilatory support

Sponsors

Hospital Provincial de Castellon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
mortality ratespatient hospital discharge

Secondary

MeasureTime frame
oxygenation improvepatient hospital discharge
diminishing of tracheal intubation incidencepatient hospital discharge
ICU and Post ICU hospital length of staypatient hospital discharge

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026