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Deflating the Tracheostomy Tube Cuff and Time for Decannulation

Primary Purpose

Deglutition Disorders, Tracheostomy Complication

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Deflate the tracheostomy cuff early
Deflate the tracheostomy cuff after complete weaning mechanical ventilation
Sponsored by
Hospital Moinhos de Vento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Deglutition Disorders focused on measuring deglutition disorders, Tracheostomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hellen de Araujo AntunesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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

Deflate the cuff after complete weaning from mechanical ventilation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 15, 2022
Last Updated
May 24, 2022
Sponsor
Hospital Moinhos de Vento
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1. Study Identification

Unique Protocol Identification Number
NCT05395728
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
July 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Moinhos de Vento

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders, Tracheostomy Complication
Keywords
deglutition disorders, Tracheostomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
A single person blinded in the study will draw the groups.
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Deflate the cuff at the beginning of the mechanical ventilation weaning protocol
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Deflate the cuff after complete weaning from mechanical ventilation
Intervention Type
Other
Intervention Name(s)
Deflate the tracheostomy cuff early
Intervention Description
The tracheostomy cuff will be early deflated, on beginning the weaning mechanical ventilation
Intervention Type
Other
Intervention Name(s)
Deflate the tracheostomy cuff after complete weaning mechanical ventilation
Intervention Description
The tracheostomy cuff will be deflated onl twenty four hours after complete weaning mechanical ventilation
Primary Outcome Measure Information:
Title
Time to reach decannulation
Description
The time between deflating the cuff for the first time and the day of decannulation will be counted for the both groups.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassiano Teixeira
Phone
+5551999687062
Email
cassiano.rush@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hellen Antunes
Phone
+5551995297706
Email
h.araujoantunes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassiano Teixeira
Organizational Affiliation
Hospital Moinhos de Vento
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hellen Antunes
Organizational Affiliation
Hospital Moinhos de Vento
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hellen de Araujo Antunes
City
Porto Alegre
State/Province
RS
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hellen Antunes
Phone
+5551995297706
Email
h.araujoantunes@gmail.com
First Name & Middle Initial & Last Name & Degree
Cassiano Teixeira
Phone
+5551999687062
Email
cassiano.rush@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be disclosed in a general way, only distributed in groups. Individual data of research participants will not be disclosed.
Citations:
Citation
CALLON J, LAMONT C, DYSON S, et al. Early cuff deflation in tracheostomised patients requiring ventilatory support. Critical Care, v. 23, 2019.
Results Reference
background

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Deflating the Tracheostomy Tube Cuff and Time for Decannulation

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