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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francesco Blasi, University of Milan
ClinicalTrials.gov Identifier:
NCT01383213
First received: June 13, 2011
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Pneumonia
Respiratory Insufficiency
Other: Oxygen therapy
Other: Helmet CPAP

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

Resource links provided by NLM:


Further study details as provided by University of Milan:

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. [ Time Frame: the reaching of the following endotracheal intubation criteria maintained for at least one hour: ] [ Designated as safety issue: No ]

    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 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]

    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


Enrollment: 81
Study Start Date: February 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383213

Locations
Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: Roberto Cosentini, MD Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico - Milano - Italy
  More Information

Publications:
Responsible Party: Francesco Blasi, Professor of Respiratory Medicine, University of Milan
ClinicalTrials.gov Identifier: NCT01383213     History of Changes
Other Study ID Numbers: SCAPOVERSO
Study First Received: June 13, 2011
Results First Received: December 31, 2013
Last Updated: December 31, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
Acute Respiratory Failure
Pneumonia
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Respiratory Insufficiency
Pneumonia
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 16, 2014