Trial Outcomes & Findings for Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO (NCT NCT00603564)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315

Results posted on

2009-12-02

Participant Flow

The Steering Committee requested an interim analysis at 20% enrollment in order to monitor the criteria for actual equipoise of the two treatments. Being this unplanned, the Lan-DeMets approach was followed and a manifest superiority of the CPAP treatment was identified, with a nominal alpha exceeding the criterion for interruption set at 0.00008.

Participant milestones

Participant milestones
Measure	CPAP (Continuous Positive Airway Pressure) CPAP delivered by a helmet	Venturi O2 administration via a conventional Venturi mask
Overall Study STARTED	20	27
Overall Study COMPLETED	20	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPAP (Continuous Positive Airway Pressure) n=20 Participants CPAP delivered by a helmet	Venturi n=27 Participants O2 administration via a conventional Venturi mask	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Age Continuous	65 years STANDARD_DEVIATION 17 • n=5 Participants	72 years STANDARD_DEVIATION 13 • n=7 Participants	69 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Italy	20 participants n=5 Participants	27 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315

Outcome measures

Outcome measures
Measure	CPAP (Continuous Positive Airway Pressure) n=20 Participants CPAP delivered by a helmet	Venturi n=27 Participants O2 administration via a conventional Venturi mask
Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315	405 minute Standard Deviation 855	2437 minute Standard Deviation 1170

SECONDARY outcome

Timeframe: 1, 6, 12, 24 and 48 hours

the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement

Outcome measures

Outcome measures
Measure	CPAP (Continuous Positive Airway Pressure) n=20 Participants CPAP delivered by a helmet	Venturi n=27 Participants O2 administration via a conventional Venturi mask
PaO2/FiO2 Ratio Mantainance	19 participants	8 participants

Adverse Events

CPAP (Continuous Positive Airway Pressure)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Venturi

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberto Cosentini, MD

IRCCS Fondazione Po.Ma.Re, Milan, Italy

Phone: 00390255033602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place