Is Positive Pressure Extubation a Safe Procedure?

Complication Clinical Trial

Official title:

Is Positive Pressure Extubation Safe Procedure? A Randomized Non-inferiority Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03174509
• Other study ID #: HGADFS14012016-01
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2017
• Last updated: June 1, 2017
• Start date: January 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: Hospital Donación Francisco Santojanni
• Contact: Mauro F Andreu, PT
• Phone: 54 11 156878298
• Email: maufede[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication

Intervention

Procedure:
• Positive pressure extubation
Positive pressure ventilation without endotracheal aspiration/suction during extubation procedure.
• Traditional during extubation
Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.

Locations

Country	Name	City	State
Argentina	Hospital Santojanni	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Donación Francisco Santojanni

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

Andreu MF, Salvati IG, Donnianni MC, Ibañez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/A presence/absence of complications after extubation	Clinical Evidence of at least one of the next complications: persistent cough, airway obstruction, post-obstructive pulmonary edema, bronchospasm, desaturation, vomiting, tachycardia, arterial hypertension.	60 minutes
Secondary	Pneumonia	Presence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography	72 hours
Secondary	Reintubation	Intubation requirement after extubation	72 hours