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Non Invasive Ventilation (NIV) Related Practices, Monitoring of the NIV Treatment Effect and of the Patient's Comfort

This study is currently recruiting participants.
Verified September 2012 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Prof. Philippe Jolliet, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01692509
First received: September 20, 2012
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

The practices and processes related to the administration of noninvasive ventilation (NIV) in the adult intensive care unit (ICU) of the University hospital of Lausanne will be recorded by an investigator at the bedside. The effect of the NIV treatment on various respiratory parameters ( respiratory rate, expired tidal volume, minute ventilation) will also be recorded using a pneumotachograph. Finally patient's comfort during NIV treatment will be evaluated.


Condition
Respiratory Failure Requiring Non Invasive Ventilation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observation of Non Invasive Ventilation (NIV) Related Practices, Monitoring of the NIV Treatment Effect and of the Patient's Comfort During NIV

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Documentation of practices and processes related to NIV treatment [ Designated as safety issue: No ]
    Documentation of practices and processes related to NIV administration in the adult intensive care unit(type of ventilator used, type of interface chosen, initial settings, organization of the care team and interactions between caregivers).


Secondary Outcome Measures:
  • Patient's Respiratory comfort [ Designated as safety issue: No ]
    Patient's respiratory comfort during NIV will be assessed both by the patients themselves with a visual analogic scale and by the investigator.

  • Ventilatory parameters [ Designated as safety issue: No ]
    Tidal volume, respiratory rate, inspiratory time, expiratory time and maximal and mean airway pressure will be measured from the continuous recording of airway pressure and flow obtained with a pneumotachograph.


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients requiring NIV
Patients requiring NIV because of acute respiratory failure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients hospitalized in the CHUV intensive care unit who require non invasive ventilation because of respiratory failure.

Criteria

Inclusion Criteria:

  • Respiratory failure
  • Therapeutic treatment by NIV required

Exclusion Criteria:

  • Age < 18 years old
  • Prophylactic NIV treatment
  • Continuous Positive Airway Pressure (CPAP)treatment
  • Denied consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692509

Contacts
Contact: Philippe Jolliet, Professor +41 79 556 16 50 Philippe.Jolliet@chuv.ch
Contact: Lise Piquilloud-Imboden, MD +41 79 556 76 42 lise.piquilloud@chuv.ch

Locations
Switzerland
Intensive care and burn unit, University Hospital of Lausanne Recruiting
Lausanne, Switzerland
Contact: Philippe Jolliet, Professor     +41 79 556 16 50     philippe.jolliet@chuv.ch    
Contact: Lise Piquilloud, MD     +41 79 556 76 42     lise.piquilloud@chuv.ch    
Principal Investigator: Philippe Jolliet, Professor            
Sub-Investigator: Lise Piquilloud-Imboden, MD            
Sub-Investigator: Jean-Pierre Revelly, MD            
Sub-Investigator: Julien Simons            
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Philippe Jolliet, Professor University of Lausanne Hospitals
  More Information

No publications provided

Responsible Party: Prof. Philippe Jolliet, Main investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01692509     History of Changes
Other Study ID Numbers: NIV related practices
Study First Received: September 20, 2012
Last Updated: September 24, 2012
Health Authority: Switzerland: Laws and standards
Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
Non invasive ventilation
Respiratory failure
Respiratory comfort

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013