Clinical trial NCT05395728: Deflating the Tracheostomy Tube Cuff and Time for Decannulation
Official title: Relationship Between Deflating the Tracheostomy Tube Cuff During Wean Mechanical Ventilation and Time for Decannulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deglutition Disorders
Tracheostomy Complication
Keywords: deglutition disorders
Tracheostomy
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to reach decannulation
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hellen de Araujo Antunes
state: RS
Study officials:
affiliation: Hospital Moinhos de Vento
name: Cassiano Teixeira
role: STUDY_DIRECTOR
affiliation: Hospital Moinhos de Vento
name: Hellen Antunes
role: PRINCIPAL_INVESTIGATOR
References:
citation: CALLON J, LAMONT C, DYSON S, et al. Early cuff deflation in tracheostomised patients requiring ventilatory support. Critical Care, v. 23, 2019.