NCT00342368

Brief Summary

Mechanical ventilation through an endotracheal tube is a lifesaving procedure for acute respiratory failure. However endotracheal intubation increases patient's discomfort and stress, and represents one of the most important predisposing factors for developing nosocomial bacterial pneumonia. In conscious and cooperative patients non invasive positive pressure ventilation (NPPV) is a safe and effective mean for treating patients with acute respiratory failure (ARF), improving gas exchanges and reducing the rate of complication related to mechanical ventilation. Facial mask, that is the conventional interface for NIV, may induce intolerance because of pain, discomfort or claustrophobia leading to discontinuation of noninvasive ventilation and endotracheal intubation. Thus the improvement of the interface between patient and ventilator seems crucial to achieve a good tolerance allowing the prolonged application of noninvasive ventilation. Attempting to improve tolerability of patients we used a new interface consisting in Helmet made in latex-free PVC. No prospective randomized controlled study has been published on the comparison between Continuous Positive Airways pressure (CPAP), delivered by an helmet and the medical treatment with Oxygen supplementation to treat early acute respiratory failure and acute lung injury. Aim of the present protocol is to compare the efficacy of CPAP delivered with helmet and conventional medical treatment with oxygen supplementation via Venturi mask, to prevent ETI in patients with early hypoxemic ARF ( paO2 /FiO2 below 300).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

June 19, 2006

Last Update Submit

October 31, 2007

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

CPAPARDSALIHypoxemiaIntubation

Outcome Measures

Primary Outcomes (1)

  • The number of endotracheal intubations over the study period

    period during the ICU stay

Secondary Outcomes (2)

  • The improvement of gas exchange

    period during icu stay

  • The complications not present on admission

    period during the icu stay

Study Arms (2)

1

ACTIVE COMPARATOR

CPAP through an helmet

Procedure: CPAP delivered by an Helmet

2

NO INTERVENTION

O2 therapy with conventional face mask

Interventions

CPAP delivered by an HelmetPROCEDURE

continuous positive airway pressures delivered through an helmet

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute Hypoxemic Respiratory failure
  • Severe Dyspnea at rest
  • Pulmonary infiltrates at chest X ray
  • PaO2/FiO2\<300
  • Respiratory Rate \> 30 breaths/min

You may not qualify if:

  • Age \< 18 years
  • COPD
  • CPE
  • Patients belonging to Class II-III-IV of the NYHA
  • Unstable angina and myocardial infarction/ cardiac surgery within the previous 3 months
  • Intubation refused or contraindicated
  • Acute Respiratory Acidosis pH \< 7.30 and PaCO2 \> 50 mmHg
  • More than 3 organ failures
  • Systolic Pressure \< 90 mmHg, under fluid resuscitation or Epinephrine or Norepinephrine \> 0.1 gamma/Kg/min
  • EKG instability with ventricular arrhythmias
  • EXPECTED surgery during the 48 hours following the enrollment
  • Coma or seizures
  • Decreased level of consciousness (GCS \<12)
  • Inability to clear secretions
  • Pre-defined intubation criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSC, Policlinico Universitario A. Gemelli, ICU

Rome, Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory InsufficiencyHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Massimo Antonelli, Prof

    Catholic University of the Sacred Heart

    STUDY DIRECTOR

Central Study Contacts

Massimo Antonelli, Prof

CONTACT

+39 06 30 15 3226m.antonelli@rm.unicatt.it

Mariano A Pennisi, Dr.

CONTACT

+39 06 30 15 4889mpennisi@rm.unicatt.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

June 1, 2005

Study Completion

March 1, 2009

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations

IT(1)