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

Respiratory Failure Requiring Non Invasive Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692509
• Other study ID #: NIV related practices
• Status: Completed
• Phase: N/A
• First received: September 20, 2012
• Last updated: June 7, 2015
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2015
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standardsSwitzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Failure Requiring Non Invasive Ventilation
• Respiratory Insufficiency

Locations

Country	Name	City	State
Switzerland	Intensive care and burn unit, University Hospital of Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of practices and processes related to NIV treatment	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).		No
Secondary	Patient's Respiratory comfort	Patient's respiratory comfort during NIV will be assessed both by the patients themselves with a visual analogic scale and by the investigator.		No
Secondary	Ventilatory parameters	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.		No