Deglutition DisordersNCT05395728
Deflating the Tracheostomy Tube Cuff and Time for Decannulation
A study testing Deflate the tracheostomy cuff early and Deflate the tracheostomy cuff after complete weaning mechanical ventilation in people with Deglutition Disorders and Tracheostomy Complication, run by Hospital Moinhos de Vento at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorders, Tracheostomy Complication
- What is being tested?
- Deflate the tracheostomy cuff early and Deflate the tracheostomy cuff after complete weaning mechanical ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Mar 2022to 12 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of head and neck cancer
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hellen de Araujo Antunes
Porto Alegre, Rio Grande do Sul
Hellen Antunes, +5551995297706, h.araujoantunes@gmail.com
Cassiano Teixeira, +5551999687062, cassiano.rush@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Deglutition Disorders, Tracheostomy Complication
- Being tested
- Deflate the tracheostomy cuff early, Deflate the tracheostomy cuff after complete weaning mechanical ventilation
- Keywords
- deglutition disorders, Tracheostomy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deflate the tracheostomy cuff earlyOther
The tracheostomy cuff will be early deflated, on beginning the weaning mechanical ventilation
Deflate the tracheostomy cuff after complete weaning mechanical ventilationOther
The tracheostomy cuff will be deflated onl twenty four hours after complete weaning mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Deflate the cuff at the beginning of the mechanical ventilation weaning protocol Receives: Other: Deflate the tracheostomy cuff early |
| Group 2 | Active comparator | Deflate the cuff after complete weaning from mechanical ventilation Receives: Other: Deflate the tracheostomy cuff after complete weaning mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start23 Mar 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion12 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cassiano Teixeira, Hospital Moinhos de Vento
- Investigators
- Cassiano Teixeira, Study director, Hospital Moinhos de VentoHellen Antunes, Principal investigator, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395728
- Sponsor's protocol ID
- Tracheostomy tube cuff
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be disclosed in a general way, only distributed in groups. Individual data of research participants will not be disclosed.
Publications
CALLON J, LAMONT C, DYSON S, et al. Early cuff deflation in tracheostomised patients requiring ventilatory support. Critical Care, v. 23, 2019.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Deflating the Tracheostomy Tube Cuff During Wean Mechanical Ventilation and Time for Decannulation
- ClinicalTrials.gov ID
- NCT05395728
- Acronym / sponsor ID
- Tracheostomy tube cuff
- Conditions
- Deglutition Disorders, Tracheostomy Complication
- Keywords
- deglutition disorders, Tracheostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 12 Jul 2023 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Deflate the tracheostomy cuff earlyDeflate the cuff at the beginning of the mechanical ventilation weaning protocol |
| Group 2 | Active comparator | Other: Deflate the tracheostomy cuff after complete weaning mechanical ventilationDeflate the cuff after complete weaning from mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of head and neck cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deflate the tracheostomy cuff earlyThe tracheostomy cuff will be early deflated, on beginning the weaning mechanical ventilation | Other | Group 1 |
| Deflate the tracheostomy cuff after complete weaning mechanical ventilationThe tracheostomy cuff will be deflated onl twenty four hours after complete weaning mechanical ventilation | Other | Group 2 |
Primary outcome
Time to reach decannulation
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.
The time between deflating the cuff for the first time and the day of decannulation will be counted for the both groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- BackgroundCALLON J, LAMONT C, DYSON S, et al. Early cuff deflation in tracheostomised patients requiring ventilatory support. Critical Care, v. 23, 2019.
- Individual participant dataSharing planned: No. The data will be disclosed in a general way, only distributed in groups. Individual data of research participants will not be disclosed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassiano Teixeira study director
Hospital Moinhos de Vento
Hellen Antunes principal investigator
Hospital Moinhos de Vento
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deflate the tracheostomy cuff early and Deflate the tracheostomy cuff after complete weaning mechanical ventilation in people with Deglutition Disorders and Tracheostomy Complication, run by Hospital Moinhos de Vento at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cassiano Teixeira (+5551999687062, cassiano.rush@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach decannulation (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05395728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.