NCT00331656

Brief Summary

Non-invasive ventilation has become increasingly important in the management of patients with acute respiratory failure. One of its major goals is to prevent the need for invasive ventilation, which is associated with numerous complications. This study compares the usefulness and safety of two noninvasive techniques which are used in Medical practice: Noninvasive positive pressure ventilation using a face mask and extrathoracic biphasic ventilation using a cuirass. Each of these techniques has advantages and disadvantages and both may not suit all patients. It is therefore important to compare the two in terms of effectiveness in preventing invasive ventilation and their side effects profile, so that we can improve our understanding and expertise in the treatment of patients in respiratory failure.

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
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2008

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

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
2 years until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2006

Enrollment Period

1 year

First QC Date

May 30, 2006

Last Update Submit

May 6, 2008

Conditions

Respiratory InsufficiencyChronic Obstructive Pulmonary DiseasePneumoniaPulmonary EdemaNeuromuscular Diseases

Keywords

noninvasivepositivecuirassventilationrespiratoryfailure

Outcome Measures

Primary Outcomes (2)

  • Need for endotracheal intubation

  • ICU and hospital mortality using the two modes

Secondary Outcomes (3)

  • Length of ventilation

  • Length of ICU and hospital stay

  • Complication rates using the two modes.

Interventions

Non-invasive positive pressure mask ventilatorsDEVICE
Extrathoracic biphasic cuirass ventilator (RTX, Hayek)DEVICE

Eligibility Criteria

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

You may qualify if:

  • Medical patients with acute respiratory failure caused by different etiologies:
  • COPD exacerbation, cardiogenic pulmonary edema, pneumonia, ARDS and neuromuscular disorders patients admitted to the Medical Intensive Care Unit

You may not qualify if:

  • Patients or family members who refuse consent for the study, Patients requiring endotracheal intubation, Post-operative patients, Patients who require sedation, Patients who are unconscious or uncooperative, Patients with acute severe asthma, Patients with massive or submassive pulmonary embolism, Patients in shock of any etiology who are hemodynamically unstable, Patients with upper airway obstruction, Patients with upper GI bleeding or epistaxis, Facial deformity or trauma, Patients who are unable to maintain a patent airway, Pregnancy, Patients under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (3)

  • Corrado A, Confalonieri M, Marchese S, Mollica C, Villella G, Gorini M, Della Porta R. Iron lung vs mask ventilation in the treatment of acute on chronic respiratory failure in COPD patients: a multicenter study. Chest. 2002 Jan;121(1):189-95. doi: 10.1378/chest.121.1.189.

    PMID: 11796450BACKGROUND

  • Gorini M, Ginanni R, Villella G, Tozzi D, Augustynen A, Corrado A. Non-invasive negative and positive pressure ventilation in the treatment of acute on chronic respiratory failure. Intensive Care Med. 2004 May;30(5):875-81. doi: 10.1007/s00134-003-2145-9. Epub 2004 Jan 21.

    PMID: 14735237BACKGROUND

  • Todisco T, Baglioni S, Eslami A, Scoscia E, Todisco C, Bruni L, Dottorini M. Treatment of acute exacerbations of chronic respiratory failure: integrated use of negative pressure ventilation and noninvasive positive pressure ventilation. Chest. 2004 Jun;125(6):2217-23. doi: 10.1378/chest.125.6.2217.

    PMID: 15189944BACKGROUND

MeSH Terms

Conditions

Respiratory InsufficiencyPulmonary Disease, Chronic ObstructivePneumoniaPulmonary EdemaNeuromuscular DiseasesRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsNervous System Diseases

Study Officials

  • Sigal Sviri, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sigal Sviri, MD

CONTACT

00 972 2 6777111sisviri@md.huji.ac.il

David M Linton, MD

CONTACT

00 972 2 6777111dlinton@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

May 7, 2008

Record last verified: 2006-05

Locations

IL(1)