Clinical trial NCT01383213: Helmet Continuous Positive Airway Pressure (CPAP) Versus Oxygen Venturi in Severe Acute Respiratory Failure in Pneumonia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Respiratory Insufficiency
Keywords: Acute Respiratory Failure
Pneumonia
Continuous Positive Airway Pressure
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. .

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: the reaching of the following endotracheal intubation criteria maintained for at least one hour:
Secondary outcomes:
measure: to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Milano - Italy
name: Roberto Cosentini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cosentini R, Brambilla AM, Aliberti S, Bignamini A, Nava S, Maffei A, Martinotti R, Tarsia P, Monzani V, Pelosi P. Helmet continuous positive airway pressure vs oxygen therapy to improve oxygenation in community-acquired pneumonia: a randomized, controlled trial. Chest. 2010 Jul;138(1):114-20. doi: 10.1378/chest.09-2290. Epub 2010 Feb 12.
citation: Squadrone V, Massaia M, Bruno B, Marmont F, Falda M, Bagna C, Bertone S, Filippini C, Slutsky AS, Vitolo U, Boccadoro M, Ranieri VM. Early CPAP prevents evolution of acute lung injury in patients with hematologic malignancy. Intensive Care Med. 2010 Oct;36(10):1666-1674. doi: 10.1007/s00134-010-1934-1. Epub 2010 Jun 9.
citation: Confalonieri M, Potena A, Carbone G, Porta RD, Tolley EA, Umberto Meduri G. Acute respiratory failure in patients with severe community-acquired pneumonia. A prospective randomized evaluation of noninvasive ventilation. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1585-91. doi: 10.1164/ajrccm.160.5.9903015.
citation: Ferrer M, Esquinas A, Leon M, Gonzalez G, Alarcon A, Torres A. Noninvasive ventilation in severe hypoxemic respiratory failure: a randomized clinical trial. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1438-44. doi: 10.1164/rccm.200301-072OC. Epub 2003 Sep 18.