Helmet Continuous Positive Airway Pressure (CPAP) Versus Oxygen Venturi in Severe Acute Respiratory Failure in Pneumonia
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Controlled Trial to Evaluate the Efficacy of CPAP Delivered by Helmet in Comparison With Oxygen Therapy by Venturi Mask in Severe Acute Respiratory Failure Caused by Pneumonia|
- to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation. [ Time Frame: the reaching of the following endotracheal intubation criteria maintained for at least one hour: ] [ Designated as safety issue: No ]
Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2<90%;Exhaustion.
The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician.
- to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of:
- CPAP: patients randomised to CPAP treatment who have changed treatment only after the reaching of the primary endpoint
- Control: patients randomised to Venturi mask treatment
- Mixed: patients who, after the treatment with Venturi mask, have needed to be treated with non-invasive CPAP
|Study Start Date:||February 2010|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: CPAP (group A)
group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
Other: Helmet CPAP
patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation
Active Comparator: oxygen therapy (group B)
group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
Other: Oxygen therapy
patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation
Pneumonia is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up to 30%.
Continuous Positive Airway Pressure (CPAP) has ben recently proved to be effective. To date, however, no prospective randomised study has been published on the comparison between CPAP and O2 administration by Venturi mask for the treatment of severe acute respiratory failure in patients with pneumonia. .
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383213
|Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico|
|Milan, Italy, 20122|
|Principal Investigator:||Roberto Cosentini, MD||Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Milano - Italy|