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Is Positive Pressure Extubation a Safe Procedure?

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03174509
Enrollment
198
Registered
2017-06-02
Start date
2017-01-01
Completion date
2017-12-31
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication

Keywords

airway extubation, positive-pressure respiration, suction, ventilator weaning

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.

Interventions

Positive pressure ventilation without endotracheal aspiration/suction during extubation procedure.

PROCEDURETraditional during extubation

Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.

Sponsors

Hospital Donación Francisco Santojanni
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The pre and post extubation parameters are recorded by an outcome assessor who do not know the assigned extubation method. The assigned extubation method is coded to minimize potential bias during data analysis.

Intervention model description

Non-inferiority trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Presence/A presence/absence of complications after extubation60 minutesClinical Evidence of at least one of the next complications: persistent cough, airway obstruction, post-obstructive pulmonary edema, bronchospasm, desaturation, vomiting, tachycardia, arterial hypertension.

Secondary

MeasureTime frameDescription
Pneumonia72 hoursPresence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography
Reintubation72 hoursIntubation requirement after extubation

Countries

Argentina

Contacts

Primary ContactMauro F Andreu, PT
maufede@hotmail.com54 11 156878298
Backup ContactMarco G Bezzi, PT
bezzi.marco@gmail.com54 11 1550620219

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026