Clinical trial NCT03174509: Is Positive Pressure Extubation a Safe Procedure?
Official title: Is Positive Pressure Extubation Safe Procedure? A Randomized Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication
Keywords: airway extubation
positive-pressure respiration
suction
ventilator weaning
Lead sponsor: Hospital Donación Francisco Santojanni
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority trial
Primary purpose: TREATMENT

Brief summary: Laboratory studies suggest extubation with positive pressure because it reduces the volume of secretions filtered into the distal airway. The aim of this non inferiority study is to evaluate the safety of the extubation technique under positive pressure with respect to the traditional technique (with suction and without positive pressure in the airways).

Detailed description: The extubation procedure consists of the removal of the endotracheal tube when it is no longer required. The literature reports two methods of extubation: the named traditional method (with suction and without positive pressure in the airways) and the positive pressure method. Laboratory studies suggest extubation at positive pressure because it reduces the volume of secretions filtered into the distal airway. Prior to apply it into clinical practice the investigators of this study consider is a priority to guarantee the safety of the positive pressure extubation method in terms of presence of complications.

The aim of this non-inferiority study is to compare the incidence of complications between both extubation techniques in adult patients with invasive mechanical ventilation.

The hypothesis of this study is that applying positive pressure during cuff deflation and extubation is not inferior to the traditional method in the incidence of complications.

Eligibility 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.

Primary outcomes:
measure: Presence/A presence/absence of complications after extubation
timeFrame: 60 minutes
Secondary outcomes:
measure: Pneumonia
timeFrame: 72 hours
measure: Reintubation
timeFrame: 72 hours
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Santojanni
Study officials:
affiliation: Hospital D. F. Santojanni
name: Mauro F Andreu, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andreu MF, Salvati IG, Donnianni MC, Ibanez B, Cotignola M, Bezzi M. Effect of applying positive pressure with or without endotracheal suctioning during extubation: a laboratory study. Respir Care. 2014 Dec;59(12):1905-11. doi: 10.4187/respcare.03121. Epub 2014 Nov 25.
citation: Andreu MF, Dotta ME, Bezzi MG, Borello S, Cardoso GP, Dib PC, Garcia Schustereder SL, Galloli AM, Castro DR, Di Giorgio VL, Villalba FJ, Bertozzi MN, Carballo JM, Martin MC, Brovia CC, Pita MC, Pedace MP, De Benedetto MF, Delli Carpini J, Aguirre P, Montero G. Safety of Positive Pressure Extubation Technique. Respir Care. 2019 Aug;64(8):899-907. doi: 10.4187/respcare.06541. Epub 2019 Mar 26.