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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383213
• Other study ID #: SCAPOVERSO
• Status: Completed
• Phase: N/A
• First received: June 13, 2011
• Last updated: December 31, 2013
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: December 2013
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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
• Helmet CPAP
patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. Epub 2003 Sep 18. — View 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):1666-74. doi: 10.1007/s00134-010-1934-1. Epub 2010 Jun 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	the reaching of the following endotracheal intubation criteria maintained for at least one hour:	No
Secondary	to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality	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	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No