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

NCT01383213 | Completed Results DMC

• 1 other identifier: SCAPOVERSO
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

Conditions

Pneumonia; Respiratory Insufficiency

Keywords

Acute Respiratory Failure; Pneumonia; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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:

Secondary Outcomes (1)

• 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

Study Arms (2)

CPAP (group A)

EXPERIMENTAL

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%

Other: Helmet CPAP

oxygen therapy (group B)

ACTIVE COMPARATOR

group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.

Other: Oxygen therapy

Interventions

Oxygen therapy OTHER

patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation

oxygen therapy (group B)

Helmet CPAP OTHER

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

CPAP (group A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

Location

Related Publications (4)

• 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.

  PMID: 20154071 BACKGROUND

• 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.

  PMID: 20533022 BACKGROUND

• 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.

  PMID: 10556125 BACKGROUND

• 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.

  PMID: 14500259 BACKGROUND

MeSH Terms

Conditions

Pneumonia; Respiratory Insufficiency

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Results Point of Contact

• Title: Dr Roberto Cosentini
• Organization: IRCCS Fondazione Cà Granda Policlinico Milano

r.cosentini@gmail.com

+390255033618

Study Officials

• Roberto Cosentini, MD

  Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Milano - Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Medicine

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 28, 2011
• Study Start: February 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 14, 2014
• Results First Posted: February 14, 2014

Record last verified: 2013-12

Locations

IT (1)