Tracheostomy ComplicationNCT06684392
Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Tracheostomized Subjects
A study testing Inspiratory muscle training in people with Tracheostomy Complication and Diaphragm Disease, run by Hospital Dr. Franco Ravera Zunino at 1 site in Chile.
Trial summary
The objective of this project is to evaluate the effect of applying an individualized inspiratory muscle training regimen, combining strength and endurance exercises over a two-week period, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Complication, Diaphragm Disease
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChile
- Study dates
- 1 Nov 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients aged ≥ 18 years
- Connected to mechanical ventilation
- Secondary tracheostomy due to prolonged mechanical ventilation
- Glasgow Coma Scale (GCS) > 11 points
- Level of cooperation score (S5Q) > 3 points
Who cannot join
- Limitation of therapeutic effort (LTE*)
- Pregnancy
- Transfer to another center before completing the training (2 weeks)
- Degenerative neuromuscular disease
- Refusal to participate in this study (declining to provide informed consent [IC]).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Hospital Regional Franco Ravera Zunino
Rancagua, Región del Libertador General Bernardo O’Higgins
Renatto Anfossi Klgo., MSc, +56987298349, hrlbo.investigacion@gmail.com
About this study
Official title: Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Adult Hospitalized Subjects with Tracheostomy Secondary to Prolonged Mechanical Ventilation
The objective of this project is to evaluate the effect of applying an individualized inspiratory muscle training regimen, combining strength and endurance exercises over a two-week period, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be assessed: an experimental group, who will follow an individualized inspiratory muscle training regimen for 14 days along with standard physiotherapy, and a control group, who will receive standard physiotherapy and guided weaning through scheduled disconnection windows from mechanical ventilation. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The results of this study will help optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and the patients, and improving their quality of life, contributing to some health objectives for the 2011-2020 decade.
Read the detailed description
Mechanical ventilation is a life-support intervention crucial for saving lives in ICU patients. However, its prolonged use leads to deterioration in respiratory muscle strength and endurance, causing diaphragm dysfunction. This weakening is associated with prolonged mechanical ventilation and increased difficulty in weaning the patient from the ventilator, known as "difficult weaning." It has been reported that up to 20% of ICU patients require tracheostomy due to this issue. Tracheostomy is an invasive procedure that involves creating an ostomy in the trachea to establish an artificial airway, allowing for ventilation, facilitating weaning from mechanical ventilation, and improving secretion management. However, muscle dysfunction from disuse and lack of effective respiratory muscle training extends the tracheostomy duration, leading to hospital-acquired infections, swallowing disorders, and increased ICU and hospital days. Thus, respiratory muscle training is a key tool for enabling tracheostomy removal (decannulation) and improving respiratory system efficiency. Since no universally accepted training protocol exists, it is not a common practice in ICUs worldwide, including our country. This project proposes that applying an individualized inspiratory muscle training regimen combining strength and endurance exercises for two weeks could improve respiratory muscle performance, reducing decannulation time (days from tracheostomy placement to removal).
The objective of this project is to assess the effect of an individualized inspiratory muscle training regimen, combining strength and endurance exercises for two weeks, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be evaluated: an experimental group undergoing individualized inspiratory muscle training for 14 days plus standard physiotherapy, and a control group receiving standard physiotherapy and weaning guided by scheduled mechanical ventilation disconnection windows. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The study results will optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and patients and improving their quality of life, thus aiding in meeting some health objectives for the 2011-2020 decade.
- Conditions
- Tracheostomy Complication, Diaphragm Disease
- Being tested
- Inspiratory muscle training
- Keywords
- tracheostomy, inspiratory muscle training, diaphragm dysfunction, diaphragm ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Subjects will train only inspiratory muscle strength if they do not achieve VP or definitive disconnection of MV, and, when they already achieve these VP or definitive disconnection, the new EMI regimen that combines strength and resistance training will begin to be applied. Inspiratory muscle training guideline (EMI). On the day that, according to the EMI guideline, the Pimax evaluation corresponds, the training time will be replaced by the evaluation to avoid overloading the subjects with ventilatory work, training them only once a day.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will follow the current protocol at HRLBO. This involves a weaning protocol from mechanical ventilation 24 hours after tracheostomy placement. Initial disconnection windows are 2 hours in the morning and 2 hours in the afternoon. If tolerated, the next day's windows are extended to 4 hours each. On the third day, the windows are extended to 6 hours each. On the fourth day, a continuous 12-hour disconnection is attempted, progressing to 24 hours if successful. Additionally, subjects will train at 50% of their maximum inspiratory pressure (MIP) in 5 sets of 6 breaths once weaned from mechanical ventilation. If tracheostomy tube occlusion (defined as temporary closure of airflow through the tracheostomy tube, using physiological ventilation) is achieved for 24 hours and the decannulation criteria are met, the tracheostomy tube will be removed. |
| Experimental Group | Experimental | The intervention group will follow the current HRLBO protocol, with the addition of an Inspiratory Muscle Training (IMT) regimen. Subjects will train only inspiratory muscle strength if they do not achieve weaning or complete disconnection from mechanical ventilation. Once they achieve weaning or disconnection, the new IMT regimen, combining strength and endurance training, will begin. On days when MIP evaluation is scheduled according to the IMT protocol, training time will be replaced by evaluation to avoid excessive ventilatory workload, limiting training to once a day. If a patient exhibits two or more clinical criteria for respiratory failure, IMT will be suspended for that day. These criteria include: RR > 35 bpm; SpO2 < 88%; HR > 130 bpm; SBP > 180 mmHg or < 90 mmHg; Modified Borg score > 6, signs of agitation, sweating, or altered consciousness. Receives: Other: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure
Maximum inspiratory pressure will be measured with the PowerBreathe valve before and after the training protocol to determine changes in diaphragm strength
Measured: 2 weeks
Secondary outcomes (2)
Diaphragm thickness
Changes in diaphragm thickness will be assessed via ultrasound before and after the training protocol.
Measured: 2 weeks
Diaphragm excursion
Changes in diaphragm excursion will be assessed via ultrasound before and after the training protocol
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Nov 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control Group (CG): The CG will follow the current protocol at HRLBO. This involves a weaning protocol from mechanical ventilation 24 hours after tracheostomy placement. Initial disconnection windows are 2 hours in the morning and 2 hours in the afternoon. If tolerated, the next day's windows extend to 4 hours each, and by the third day, to 6 hours. On the fourth day, a continuous 12-hour disconnection is attempted, progressing to 24 if successful. Additionally, subjects will train at 50% of their MIP in 5 sets of 6 breaths once weaned. Intervention Group (IG): The IG will follow the CG protocol plus inspiratory muscle training (IMT). If weaning or disconnection is not achieved, subjects will train for inspiratory strength alone. Once weaning or disconnection is successful, the new IMT protocol combining strength and endurance training will begin. If the patient shows clinical signs of respiratory failure, IMT will be paused for the day.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Dr. Franco Ravera Zunino
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684392
- Sponsor's protocol ID
- FONIS2024
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Adult Hospitalized Subjects with Tracheostomy Secondary to Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06684392
- Acronym / sponsor ID
- FONIS2024
- Conditions
- Tracheostomy Complication, Diaphragm Disease
- Keywords
- tracheostomy, inspiratory muscle training, diaphragm dysfunction, diaphragm ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital Dr. Franco Ravera ZuninoUniversity, hospital or other
- Collaborators
- University of Chile
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 12 Nov 2024 (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.
The objective of this project is to evaluate the effect of applying an individualized inspiratory muscle training regimen, combining strength and endurance exercises over a two-week period, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be assessed: an experimental group, who will follow an individualized inspiratory muscle training regimen for 14 days along with standard physiotherapy, and a control group, who will receive standard physiotherapy and guided weaning through scheduled disconnection windows from mechanical ventilation. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The results of this study will help optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and the patients, and improving their quality of life, contributing to some health objectives for the 2011-2020 decade.
Detailed description
Mechanical ventilation is a life-support intervention crucial for saving lives in ICU patients. However, its prolonged use leads to deterioration in respiratory muscle strength and endurance, causing diaphragm dysfunction. This weakening is associated with prolonged mechanical ventilation and increased difficulty in weaning the patient from the ventilator, known as "difficult weaning." It has been reported that up to 20% of ICU patients require tracheostomy due to this issue. Tracheostomy is an invasive procedure that involves creating an ostomy in the trachea to establish an artificial airway, allowing for ventilation, facilitating weaning from mechanical ventilation, and improving secretion management. However, muscle dysfunction from disuse and lack of effective respiratory muscle training extends the tracheostomy duration, leading to hospital-acquired infections, swallowing disorders, and increased ICU and hospital days. Thus, respiratory muscle training is a key tool for enabling tracheostomy removal (decannulation) and improving respiratory system efficiency. Since no universally accepted training protocol exists, it is not a common practice in ICUs worldwide, including our country. This project proposes that applying an individualized inspiratory muscle training regimen combining strength and endurance exercises for two weeks could improve respiratory muscle performance, reducing decannulation time (days from tracheostomy placement to removal).
The objective of this project is to assess the effect of an individualized inspiratory muscle training regimen, combining strength and endurance exercises for two weeks, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be evaluated: an experimental group undergoing individualized inspiratory muscle training for 14 days plus standard physiotherapy, and a control group receiving standard physiotherapy and weaning guided by scheduled mechanical ventilation disconnection windows. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The study results will optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and patients and improving their quality of life, thus aiding in meeting some health objectives for the 2011-2020 decade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Control Group (CG): The CG will follow the current protocol at HRLBO. This involves a weaning protocol from mechanical ventilation 24 hours after tracheostomy placement. Initial disconnection windows are 2 hours in the morning and 2 hours in the afternoon. If tolerated, the next day's windows extend to 4 hours each, and by the third day, to 6 hours. On the fourth day, a continuous 12-hour disconnection is attempted, progressing to 24 if successful. Additionally, subjects will train at 50% of their MIP in 5 sets of 6 breaths once weaned. Intervention Group (IG): The IG will follow the CG protocol plus inspiratory muscle training (IMT). If weaning or disconnection is not achieved, subjects will train for inspiratory strength alone. Once weaning or disconnection is successful, the new IMT protocol combining strength and endurance training will begin. If the patient shows clinical signs of respiratory failure, IMT will be paused for the day.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will follow the current protocol at HRLBO. This involves a weaning protocol from mechanical ventilation 24 hours after tracheostomy placement. Initial disconnection windows are 2 hours in the morning and 2 hours in the afternoon. If tolerated, the next day's windows are extended to 4 hours each. On the third day, the windows are extended to 6 hours each. On the fourth day, a continuous 12-hour disconnection is attempted, progressing to 24 hours if successful. Additionally, subjects will train at 50% of their maximum inspiratory pressure (MIP) in 5 sets of 6 breaths once weaned from mechanical ventilation. If tracheostomy tube occlusion (defined as temporary closure of airflow through the tracheostomy tube, using physiological ventilation) is achieved for 24 hours and the decannulation criteria are met, the tracheostomy tube will be removed. |
| Experimental Group | Experimental | Other: Inspiratory muscle trainingThe intervention group will follow the current HRLBO protocol, with the addition of an Inspiratory Muscle Training (IMT) regimen. Subjects will train only inspiratory muscle strength if they do not achieve weaning or complete disconnection from mechanical ventilation. Once they achieve weaning or disconnection, the new IMT regimen, combining strength and endurance training, will begin. On days when MIP evaluation is scheduled according to the IMT protocol, training time will be replaced by evaluation to avoid excessive ventilatory workload, limiting training to once a day. If a patient exhibits two or more clinical criteria for respiratory failure, IMT will be suspended for that day. These criteria include: RR > 35 bpm; SpO2 < 88%; HR > 130 bpm; SBP > 180 mmHg or < 90 mmHg; Modified Borg score > 6, signs of agitation, sweating, or altered consciousness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Critically ill patients aged ≥ 18 years
- Connected to mechanical ventilation
- Secondary tracheostomy due to prolonged mechanical ventilation
- Glasgow Coma Scale (GCS) > 11 points
- Level of cooperation score (S5Q) > 3 points
Key exclusion criteria (5 listed)
- Limitation of therapeutic effort (LTE*)
- Pregnancy
- Transfer to another center before completing the training (2 weeks)
- Degenerative neuromuscular disease
- Refusal to participate in this study (declining to provide informed consent [IC]).
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 |
|---|---|---|
| Inspiratory muscle trainingSubjects will train only inspiratory muscle strength if they do not achieve VP or definitive disconnection of MV, and, when they already achieve these VP or definitive disconnection, the new EMI regimen that combines strength and resistance training will begin to be applied. Inspiratory muscle training guideline (EMI). On the day that, according to the EMI guideline, the Pimax evaluation corresponds, the training time will be replaced by the evaluation to avoid overloading the subjects with ventilatory work, training them only once a day. | Other | Experimental Group |
Primary outcome
Maximal inspiratory pressure
Time frame: 2 weeks
Maximum inspiratory pressure will be measured with the PowerBreathe valve before and after the training protocol to determine changes in diaphragm strength
2 secondary outcomes
Diaphragm thickness
Time frame: 2 weeks
Diaphragm excursion
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Tracheostomy Complication and Diaphragm Disease, run by Hospital Dr. Franco Ravera Zunino at 1 site in Chile.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. 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 Chile. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kinesióloga Jennifer Ayuso, Master of science (+56966453201, jenniferayuso@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.