NCT00956540

Brief Summary

The purpose of this study is to determine whether deflating the tracheal cuff in tracheostomized patients, during disconnections from ventilatory support along the weaning phase shortens the weaning time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 6, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5 months until next milestone

Results Posted

Study results publicly available

September 27, 2011

Completed
Last Updated

September 27, 2011

Status Verified

August 1, 2011

Enrollment Period

1.4 years

First QC Date

August 6, 2009

Results QC Date

July 1, 2011

Last Update Submit

August 19, 2011

Conditions

WeaningTracheostomy

Keywords

TracheostomydecannulationweaningTracheostomy Weaning

Outcome Measures

Primary Outcomes (1)

  • Weaning Time

    The weaning time starts at the first disconnection from mechanical ventilation lasting \>30 minutes and ends after the patient tolerate 24 consecutive hours disconnected from mechanical ventilation.

    6 months

Secondary Outcomes (1)

  • Tracheobronchitis and Pneumonia

    6 months

Study Arms (4)

Deflating

EXPERIMENTAL

Deflating tracheal cuff (total air suction under negative pressure using a syringe) during periods of disconnection from mechanical ventilation in the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support. During ventilatory support the tracheal cuff remain pressurized (30 mmHg).

Procedure: Deflating tracheal cuff

Not deflating

NO INTERVENTION

The tracheal cuff remain inflated all the time during the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support

Deflating 2

EXPERIMENTAL

Deflating tracheal cuff during periods of disconnection from mechanical ventilation in the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate mange the airway.

Procedure: Deflating tracheal cuff 2

Not deflating 2

NO INTERVENTION

The tracheal cuff remain inflated all the time during the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate mange the airway.

Interventions

Deflating tracheal cuffPROCEDURE

Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support.

Deflating
Deflating tracheal cuff 2PROCEDURE

Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.

Deflating 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prolonged time under mechanical ventilation (\>21 days) or prolonged weaning.
  • Motor component of Glasgow Coma Score \<6 points or inability to adequate manage the airway (\>2 aspirations every 8 hours).

You may not qualify if:

  • High risk of aspiration (neuromuscular disease affecting bulbar functions, tracheostomies indicated as a part of a surgical procedure involving the upper airway or high risk of aspiration observed after specific evaluation previous to randomization).
  • Death before starting weaning attempts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Virgen de la Salud

Toledo, Toledo, 45004, Spain

Location

Related Publications (1)

  • Hernandez G, Pedrosa A, Ortiz R, Cruz Accuaroni Mdel M, Cuena R, Vaquero Collado C, Garcia Plaza S, Gonzalez Arenas P, Fernandez R. The effects of increasing effective airway diameter on weaning from mechanical ventilation in tracheostomized patients: a randomized controlled trial. Intensive Care Med. 2013 Jun;39(6):1063-70. doi: 10.1007/s00134-013-2870-7. Epub 2013 Mar 8.

    PMID: 23471512DERIVED

Results Point of Contact

Title
Dr. Gonzalo Hernández
Organization
Hospital Virgen de la Salud
ghernandezm@telefonica.net
0034629625428

Study Officials

  • Gonzalo Hernandez, MD

    Hospital Virgen de la Salud

    STUDY CHAIR

  • Maria del Mar Cruz, MD

    Hospital Virgen de la Salud

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FEA Medicina Intensiva

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 11, 2009

Study Start

December 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

September 27, 2011

Results First Posted

September 27, 2011

Record last verified: 2011-08

Locations

ES(1)