NCT03174509

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

May 30, 2017

Last Update Submit

June 1, 2017

Conditions

Complication

Keywords

airway extubationpositive-pressure respirationsuctionventilator weaning

Outcome Measures

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.

    60 minutes

Secondary Outcomes (2)

  • Pneumonia

    72 hours

  • Reintubation

    72 hours

Study Arms (2)

Positive Pressure Extubation

ACTIVE COMPARATOR

Positive pressure extubation is used for patients in this group.

Procedure: Positive pressure extubation

Traditional Extubation

ACTIVE COMPARATOR

Traditional extubation is used for patients in this group.

Procedure: Traditional during extubation

Interventions

Positive pressure extubationPROCEDURE

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

Positive Pressure Extubation
Traditional during extubationPROCEDURE

Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.

Traditional Extubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Invasive Mechanical Ventilation with endotracheal tube.
  • years and older.
  • Successful 30 minutes spontaneous breathing trial (SBT).
  • Extubation Criteria.
  • Informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Santojanni

Buenos Aires, 1408, Argentina

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25425709BACKGROUND

  • 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.

    PMID: 30914493DERIVED

Study Officials

  • Mauro F Andreu, PT

    Hospital D. F. Santojanni

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro F Andreu, PT

CONTACT

54 11 156878298maufede@hotmail.com

Marco G Bezzi, PT

CONTACT

54 11 1550620219bezzi.marco@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-inferiority trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 2, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

June 5, 2017

Record last verified: 2017-06

Locations

AR(1)