Non-Invasive Ventilation After Extubation in Hypercapnic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00539708
• Date of registration: 03/10/2007
• Prospective Registration: No
• Primary sponsor: Hospital Clinic of Barcelona
• Public title: Non-Invasive Ventilation After Extubation in Hypercapnic Patients
• Scientific title: Non-Invasive Ventilation After Extubation in Hypercapnic Patients
• Date of first enrolment: May 2005
• Target sample size: 106
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00539708
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Miquel Ferrer, MD, PhD
• Affiliation: UVIIR. Servei de Pneumologia, Hospital Clinic,Barcelona

Key inclusion & exclusion criteria

Inclusion Criteria:

- Chronic respiratory disorders with invasive mechanical ventilation

- Hypercapnic respiratory failure during successful spontaneous breathing trial

Exclusion Criteria:

- Face or cranial trauma or surgery

- Recent gastric or esophageal surgery

- Tracheostomy or other upper airway disorders

- Upper gastrointestinal bleeding

- Excess respiratory secretions

- Lack of collaboration



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Respiratory Failure

Intervention(s)

Procedure: Non-invasive ventilation

Primary Outcome(s)

Primary outcome: The incidence of respiratory failure after extubation [Time Frame: 3 days after extubation]

Secondary Outcome(s)

Survival [Time Frame: 90 days]

Secondary ID(s)

FIS 041130

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fondo de Investigacion Sanitaria