Cough Determinants in Mechanically Ventilated Patients

Mechanical Ventilation Clinical Trial

— Extu-Cough  

Official title:

Cough Determinants in Mechanically Ventilated Patients: a Physiological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564745
• Other study ID #: Extu-Cough
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In our knowledge there is only few data about the cough determinants in mechanically ventilated patients. However some failure of extubation is due to inefficiency cough. In order to determine some determinants of cough, the investigators propose to evaluate systematically different physiological parameters before and after extubation.

Description:

In order to evaluate, and identify the cough determinants, the investigators propose a physiological evaluation for each patients who were intubated and mechanically ventilated during at least 72 hours. Indeed inefficacy of cough after extubation is one of the main reason of extubation failure. However there is no any mean to evaluate it simply now.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients mechanically ventilated since 72h

• Age > 18 years

• Hospitalized in Intensive care Unit

• In weaning phase - with the classically criteria to be extubated

• Patients who passed the weaning test (T tube test or other)

Exclusion Criteria:

• Hemodynamic instability

• Absence of consent

• No cooperation of the patient

• Hemodynamic instability

• pH < 7,30

• Severe hypoxemia

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Other:
• Functional respiratory evaluation
Each enrolled patients has a pulmonary function test before and after extubation, and repeatedly at D1, D3, D5 (if they are always hospitalized)

Locations

Country	Name	City	State
France	University Hospital, Caen	Caen
France	University Hospital, Garches	Garches

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Caen	Centre d'Investigation Clinique et Technologique 805, INSERM U1075,Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interest of systematically cough evaluation before extubation	All the patients enrolled have a physiological evaluation before and after extubation. After extubation the evaluation will be done respectively at D0, D1, D3 and D5. The first endpoint is the success of extubation which is evaluated à D2.	2 days after extubation
Secondary	Correlation between success of extubation and respiratory parameters		2 days after extubation