Trial Outcomes & Findings for Helmet Continuous Positive Airway Pressure (CPAP) Versus Oxygen Venturi in Severe Acute Respiratory Failure in Pneumonia (NCT NCT01383213)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

the reaching of the following endotracheal intubation criteria maintained for at least one hour:

Results posted on

2014-02-14

Participant Flow

Feb. 2010-feb 2013 5 Italian High Dependence Units

Exclusion criteria

Participant milestones

Participant milestones
Measure	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%	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%.
Overall Study STARTED	40	41
Overall Study COMPLETED	40	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Helmet Continuous Positive Airway Pressure (CPAP) Versus Oxygen Venturi in Severe Acute Respiratory Failure in Pneumonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPAP (Group A) n=40 Participants 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%	Oxygen Therapy (Group B) n=41 Participants group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.	Total n=81 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	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Age, Continuous	64.9 years STANDARD_DEVIATION 16.1 • n=5 Participants	69.5 years STANDARD_DEVIATION 15.8 • n=7 Participants	67.2 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment Italy	40 participants n=5 Participants	41 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: the reaching of the following endotracheal intubation criteria maintained for at least one hour:

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.

Outcome measures

Outcome measures
Measure	CPAP (Group A) n=40 Participants 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% Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation	Oxygen Therapy (Group B) n=41 Participants group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%. Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation
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.	6 participants	26 participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of: 1. CPAP: patients randomised to CPAP treatment who have changed treatment only after the reaching of the primary endpoint 2. Control: patients randomised to Venturi mask treatment 3. Mixed: patients who, after the treatment with Venturi mask, have needed to be treated with non-invasive CPAP

Outcome measures

Outcome data not reported

Adverse Events

CPAP (Group A)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxygen Therapy (Group B)

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CPAP (Group A) n=40 participants at risk 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% Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation	Oxygen Therapy (Group B) n=41 participants at risk group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%. Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation
Respiratory, thoracic and mediastinal disorders in-hospital mortality	5.0% 2/40 • Number of events 2	17.1% 7/41 • Number of events 7

Other adverse events

Adverse event data not reported

Additional Information

Dr Roberto Cosentini

IRCCS Fondazione Cà Granda Policlinico Milano

Phone: +390255033618

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place