Non-Positive Pressure Ventilation in Hypoxemic Patients

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925860
• Other study ID #: HGCS-2009-1
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2009
• Last updated: June 19, 2009
• Start date: June 2001
• Est. completion date: June 2007

Study information

• Verified date: June 2009
• Source: Hospital Provincial de Castellon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• non positive pressure mechanical ventilatory support

Locations

Country	Name	City	State
Spain	Intensive Care Department - General Hospital	Castello

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Provincial de Castellon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rates		patient hospital discharge	Yes
Secondary	oxygenation improve		patient hospital discharge	No
Secondary	diminishing of tracheal intubation incidence		patient hospital discharge	No
Secondary	ICU and Post ICU hospital length of stay		patient hospital discharge	No