Deflating the Tracheostomy Tube Cuff and Time for Decannulation

Deglutition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05395728
• Other study ID #: Tracheostomy tube cuff
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: May 2022
• Source: Hospital Moinhos de Vento
• Contact: Cassiano Teixeira
• Phone: +5551999687062
• Email: cassiano.rush[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: July 12, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Tracheostomy Complication

Intervention

Other:
• Deflate the tracheostomy cuff early
The tracheostomy cuff will be early deflated, on beginning the weaning mechanical ventilation
• Deflate the tracheostomy cuff after complete weaning mechanical ventilation
The tracheostomy cuff will be deflated onl twenty four hours after complete weaning mechanical ventilation

Locations

Country	Name	City	State
Brazil	Hellen de Araujo Antunes	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.