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

Primary Purpose

Pneumonia, Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Oxygen therapy
Helmet CPAP
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Acute Respiratory Failure, Pneumonia, Continuous Positive Airway Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CPAP (group A)

oxygen therapy (group B)

Arm Description

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%

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2011
Last Updated
December 31, 2013
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT01383213
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Respiratory Insufficiency
Keywords
Acute Respiratory Failure, Pneumonia, Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP (group A)
Arm Type
Experimental
Arm Description
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%
Arm Title
oxygen therapy (group B)
Arm Type
Active Comparator
Arm Description
group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
Intervention Type
Other
Intervention Name(s)
Oxygen therapy
Intervention Description
patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation
Intervention Type
Other
Intervention Name(s)
Helmet CPAP
Intervention Description
patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
the reaching of the following endotracheal intubation criteria maintained for at least one hour:
Secondary Outcome Measure Information:
Title
to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality
Description
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
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Cosentini, MD
Organizational Affiliation
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Milano - Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20154071
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.
Results Reference
background
PubMed Identifier
20533022
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.
Results Reference
background
PubMed Identifier
10556125
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.
Results Reference
background
PubMed Identifier
14500259
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.
Results Reference
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Helmet Continuous Positive Airway Pressure (CPAP) Versus Oxygen Venturi in Severe Acute Respiratory Failure in Pneumonia

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