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

December 31, 2013 updated by: Francesco Blasi, University of Milan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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%
Other: Helmet CPAP
patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation
ACTIVE_COMPARATOR: 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%.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
the reaching of the following endotracheal intubation criteria maintained for at least one hour:

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality
Time Frame: 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
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Roberto Cosentini, MD, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Milano - Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (ESTIMATE)

June 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2014

Last Update Submitted That Met QC Criteria

December 31, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAPOVERSO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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