Deflating the Tracheostomy Tube Cuff and Time for Decannulation

NCT05395728 | Unknown

• 1 other identifier: Tracheostomy tube cuff
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Inpatients in an intensive care unit can need tracheostomy. To start the tracheostomy decannulation process, one of the procedures is to deflate the cuff. Purpose: Check whether to set the cuff early reduction of tracheostomy use. Methodology: This is a randomized clinical trial, where the cuff of the experimental group will be deflated from the beginning of periods without mechanical ventilation, and the control group after 24 hours without mechanical ventilation. Will be included tracheostomized patients weaning the mechanical ventilation, and excluded those who do not have the consent form signed.

Conditions

Deglutition Disorders; Tracheostomy Complication

Keywords

deglutition disorders; Tracheostomy

Outcome Measures

Primary Outcomes (1)

• Time to reach decannulation

  The time between deflating the cuff for the first time and the day of decannulation will be counted for the both groups.

  Will be measured in days. Two points will be considered: day that the cuff was deflated and day of decannulation, with an estimated period of 4 weeks.

Study Arms (2)

Group 1

EXPERIMENTAL

Deflate the cuff at the beginning of the mechanical ventilation weaning protocol

Other: Deflate the tracheostomy cuff early

Group 2

ACTIVE COMPARATOR

Deflate the cuff after complete weaning from mechanical ventilation

Other: Deflate the tracheostomy cuff after complete weaning mechanical ventilation

Interventions

Deflate the tracheostomy cuff early OTHER

The tracheostomy cuff will be early deflated, on beginning the weaning mechanical ventilation

Group 1

Deflate the tracheostomy cuff after complete weaning mechanical ventilation OTHER

The tracheostomy cuff will be deflated onl twenty four hours after complete weaning mechanical ventilation

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Request for speech therapy evaluation by the medical team
• Use of tracheostomy
• Indication to start the weaning process from mechanical ventilation
• Consent to the Free and Informed Consent Form by the patient or by the legal responsible

You may not qualify if:

• \- Diagnosis of head and neck cancer

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead

Study Sites (1)

Hellen de Araujo Antunes

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (1)

• CALLON J, LAMONT C, DYSON S, et al. Early cuff deflation in tracheostomised patients requiring ventilatory support. Critical Care, v. 23, 2019.

  BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Cassiano Teixeira

  Hospital Moinhos de Vento

  STUDY DIRECTOR

• Hellen Antunes

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassiano Teixeira

CONTACT

+5551999687062; cassiano.rush@gmail.com

Hellen Antunes

CONTACT

+5551995297706; h.araujoantunes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A single person blinded in the study will draw the groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial. Group 1: deflate the cuff at the beginning of the weaning protocol from mechanical ventilation. Group 2: deflate after complete weaning from mechanical ventilation.

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 27, 2022
• Study Start: March 23, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 12, 2023
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)