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

Not Applicable

Completed

• Conditions: Pneumonia; Respiratory Insufficiency
• Interventions: Other: Helmet CPAP; Other: Oxygen therapy

• Registration Number: NCT01383213
• Lead Sponsor: University of Milan

Brief Summary

The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2 administration by a Venturi mask in terms of achievement of criteria for endotracheal intubation during severe acute respiratory failure caused by pneumonia

Detailed Description

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. .

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-12
• Results First Submitted: 2013-12-31
• Results First Submitted QC: 2013-12-31
• Last Update Submitted: 2013-12-31
• Results First Posted: 2014-02-14
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• men and women of any ethnic group;
• age ≥18 years;
• dyspnoea at rest with respiratory rate (RR) ≥30 breath/min or sign of respiratory distress
• PaO2/FiO2 ratio≤250 evaluated during oxygen therapy supplied at least 1 hour through a Venturi mask with FiO2 ≥0,50
• diagnosis of pneumonia as unique cause of severe acute respiratory failure
• informed consent from each patient or from the closest relative in case of the patient's incapacity to give it

Exclusion Criteria

• diagnosis of other causes of severe acute respiratory failure
• unstable angina or acute myocardial infarction;
• acute respiratory acidosis with pH <7,35 and PaCO2 >45 mmHg;
• systolic BP <90 mmHg despite fluid resuscitation or vasopressors;
• severe arrhythmias;
• convulsions;
• degree of consciousness, Kelly score>3;
• swallowing disturbance with increasing risk of aspiration pneumonia;
• inability to protect the airway;
• recent facial trauma or burn;
• non-collaborative patient;
• presence of open wounds (head, thorax, abdomen);
• respiratory arrest or need of intubation;
• pregnancy or suspect of pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP (group A)	Helmet CPAP	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)	Oxygen therapy	group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality	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

Trial Locations

Locations (1)

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy