Deflating the Tracheostomy Tube Cuff and Time for Decannulation

Relationship Between Deflating the Tracheostomy Tube Cuff During Wean Mechanical Ventilation and Time for Decannulation

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.

Study Overview

• Status: Recruiting
• Conditions: Deglutition Disorders; Tracheostomy Complication
• Intervention / Treatment: Other: Deflate the tracheostomy cuff early; Other: Deflate the tracheostomy cuff after complete weaning mechanical ventilation

Detailed Description

The general objective is to verify that patients who go through the process of deflating the cuff from the initiation of weaning from mechanical ventilation meet criteria for decannulation before patients who deflate the cuff only after 24 hours of weaning.

The study will be carried out in the Intensive Care Unit of Hospital Moinhos de Vento, located in the city of Porto Alegre/RS

The evaluation must take place according to the following steps, after the request of the medical team: Check if the patient meets the inclusion criteria; Raffle to verify if the patient will participate in the study group or the group control; The draw will be performed by a person blinded to the study; Application of the informed consent to the patient or legal guardian; Collection of data in medical records; Explain the procedures to the patient; Position the patient as seated as possible; Tracheal aspiration; Deflate the cuff; Tracheal aspiration after deflating the cuff; Collect data from the moment of the evaluation; The assessment will be recorded in the patient's electronic medical record by the speech therapist at the service; Monitor the moment the patient reaches the criteria for decannulation after complete weaning from mechanical ventilation. For the control group, the same procedures will be performed after complete 24 continuous hours without the use of mechanical ventilation

The following clinical data will be collected in electronic medical records: sex, date of birth, age, reason for hospitalization, comorbidities, date of hospitalization, date of orotracheal intubation procedure and date of tracheostomy procedure. At the time of evaluation, the following variables will be collected: tracheostomy; time in ayre (without mechanical ventilation); oxygen saturation, heart and respiratory rate before and after cuff deflation; cough strength (weak, strong, absent); cough quality (effective, ineffective); saliva swallowing (spontaneous, on command, absent), date of decannulation.

After the evaluation, the following variables will be collected to consider the patient decannulation: permeability of the air passage during occlusion of the tracheostomy, tolerance of occluded tracheostomy, management of secretion and efficiency of saliva swallowing.

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassiano Teixeira; Phone Number: +5551999687062; Email: cassiano.rush@gmail.com
• Study Contact Backup: Name: Hellen Antunes; Phone Number: +5551995297706; Email: h.araujoantunes@gmail.com

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil
      • Recruiting
      • Hellen de Araujo Antunes
      • Contact: Cassiano Teixeira; Phone Number: +5551999687062; Email: cassiano.rush@gmail.com
      • Contact: Hellen Antunes; Phone Number: +5551995297706; Email: h.araujoantunes@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

- Diagnosis of head and neck cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Deflate the cuff at the beginning of the mechanical ventilation weaning protocol	Other: Deflate the tracheostomy cuff early; The tracheostomy cuff will be early deflated, on beginning the weaning mechanical ventilation
Active Comparator: Group 2; Deflate the cuff after complete weaning from mechanical ventilation	Other: Deflate the tracheostomy cuff after complete weaning mechanical ventilation; The tracheostomy cuff will be deflated onl twenty four hours after complete weaning mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Investigators: Study Director: Cassiano Teixeira, Hospital Moinhos de Vento; Principal Investigator: Hellen Antunes, Hospital Moinhos de Vento

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): July 12, 2023

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Tracheostomy; deglutition disorders
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: Tracheostomy tube cuff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data will be disclosed in a general way, only distributed in groups. Individual data of research participants will not be disclosed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No