CClinicalTrials.gg
Status unknownNCT03174509Updated Jun 5, 2017

Is Positive Pressure Extubation a Safe Procedure?

An interventional study of Positive pressure extubation and Traditional during extubation in Complication, sponsored by Hospital Donación Francisco Santojanni. Status unknown at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-05.

Sponsored by Hospital Donación Francisco Santojanni · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2017, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Complication

Keywords

  • airway extubation
  • positive-pressure respiration
  • suction
  • ventilator weaning
03

In context

Lead sponsor

Hospital Donación Francisco Santojanni is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Previous airway surgery or injury.
  • Non-Invasive Ventilation as weaning method.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
198 participants (estimated)

Study arms

  • Active comparator
    Positive Pressure Extubation

    Positive pressure extubation is used for patients in this group.

    Procedure: Positive pressure extubation

  • Active comparator
    Traditional Extubation

    Traditional extubation is used for patients in this group.

    Procedure: Traditional during extubation

Interventions

  • ProcedurePositive pressure extubation

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

  • ProcedureTraditional during extubation

    Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 60 minutes

Secondary outcomes

  1. Pneumonia

    Presence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography

    Time frame: 72 hours

  2. Reintubation

    Intubation requirement after extubation

    Time frame: 72 hours

07

Study locations

1 of 1 sites recruiting
  • Hospital Santojanni
    Buenos Aires, 1408, Argentina
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25425709 ↗
  • 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. PubMed 30914493 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03174509
Lead sponsor
Hospital Donación Francisco Santojanni
Responsible party
Mauro Andreu (Physical Therapist, Hospital Donación Francisco Santojanni) — Principal investigator
First posted
Jun 2, 2017
Start date
Jan 1, 2017
Primary completion
Dec 31, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Jun 5, 2017

Study contacts

Mauro F Andreu, PT
Contact
maufede@hotmail.com
54 11 156878298
Marco G Bezzi, PT
Contact
bezzi.marco@gmail.com
54 11 1550620219
Mauro F Andreu, PT
principal investigator · Hospital D. F. Santojanni

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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