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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT03174509
Date of registration:	30/05/2017
Prospective Registration:	No
Primary sponsor:	Hospital Donación Francisco Santojanni
Public title:	Is Positive Pressure Extubation a Safe Procedure?
Scientific title:	Is Positive Pressure Extubation Safe Procedure? A Randomized Non-inferiority Trial.
Date of first enrolment:	January 1, 2017
Target sample size:	198
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03174509
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Argentina

Contacts

Name:	Mauro F Andreu, PT
Address:
Telephone:
Email:
Affiliation:	Hospital D. F. Santojanni

Name:	Mauro F Andreu, PT
Address:
Telephone:	54 11 1568788298
Email:	maufede@hotmail.com
Affiliation:

Name:	Mauro F Andreu, PT
Address:
Telephone:	54 11 156878298
Email:	maufede@hotmail.com
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

- Invasive Mechanical Ventilation with endotracheal tube.

- 18 years and older.

- Successful 30 minutes spontaneous breathing trial (SBT).

- Extubation Criteria.

- Informed consent.

Exclusion Criteria:

- Previous airway surgery or injury.

- Non-Invasive Ventilation as weaning method.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Complication

Intervention(s)

Procedure: Traditional during extubation

Procedure: Positive pressure extubation

Primary Outcome(s)

Presence/A presence/absence of complications after extubation [Time Frame: 60 minutes]

Secondary Outcome(s)

Reintubation [Time Frame: 72 hours]

Pneumonia [Time Frame: 72 hours]

Secondary ID(s)

HGADFS14012016-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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