Mechanical Ventilator WeaningNCT02566512
Assessment of Cough Strength in Patients With Tracheostomies
A study testing Tracheostomy cuff inflation. and Tracheostomy cuff deflation in people with Mechanical Ventilator Weaning, run by University of Manitoba at 1 site in Canada.
Trial summary
The investigators propose to assess cough strength in patients undergoing spontaneous breathing trials in the Intermediate Intensive Care Unit (IICU) and compare their cough strength under two conditions, 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mechanical Ventilator Weaning
- What is being tested?
- Tracheostomy cuff inflation. and Tracheostomy cuff deflation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Oct 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study group will include all adult patients in the IICU, on prolonged mechanical ventilation who are having spontaneous breathing trials as part of their weaning protocol.
Who cannot join
- Any patient who has a leak around their tracheostomy tube when the tracheostomy cuff is inflated.
- Inability to understand English or cognitive impairment which impairs the patient's ability to follow directions.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to assess cough strength in patients undergoing spontaneous breathing trials in the Intermediate Intensive Care Unit (IICU) and compare their cough strength under two conditions,
- Tracheostomy cuff inflated: cough strength will be measured with the tracheostomy cuff inflated and the patient coughing through the tracheostomy tube.
- Tracheostomy cuff deflated: cough strength will be measured with the tracheostomy cuff deflated and the patient coughing around the tracheostomy tube, through their mouth..
The investigators hypothesize that patients will have a stronger cough when they can use their vocal cords.
Read the detailed description
When a patient has recovered from the initial respiratory insult which precipitated respiratory failure, the patient may need a prolonged period of time to wean completely from mechanical ventilation.
One method of weaning from mechanical ventilation involves having the patient breath spontaneously without the assistance of the ventilator. This is referred to as a spontaneous breathing trial. Over time, the duration of spontaneous breathing is gradually increased until the patient is able to breathe entirely on their own. Traditionally, the tracheostomy cuff has been kept inflated until the patient can breathe entirely on their own (2,3).
A recent study has assessed the effect of deflating the tracheostomy tube cuff on weaning from mechanical ventilation (4). Patients, who required prolonged mechanical ventilation and had a tracheostomy, were weaned using a T piece trial. They were randomized to two groups: the control group had the tracheostomy cuff kept inflated; the study group had the tracheostomy cuff deflated. The study group, with the cuff deflated, had a shorter time to weaning from the ventilator, fewer respiratory infections and improved swallowing. This was attributed to an increase in the effective airway diameter, which would decrease the resistive work of breathing. The authors did not comment on the effect cuff deflation may have on coughing and clearance of secretions.
It is postulated that patients can cough more effectively when he/she can use their vocal cords to generate a cough as opposed to coughing through a tracheostomy tube where the vocal cords are bypassed. It has been previously demonstrated that patients have a stronger cough after the tracheostomy tube has been removed as compared to when the tracheostomy tube is in place (5).
Patient population
The study group will include all adult patients in the IICU, on prolonged mechanical ventilation who are having spontaneous breathing trials as part of their weaning protocol.
Patients will be required to give written, informed consent.
Exclusion criteria
Any patient who has a leak around their tracheostomy tube when the tracheostomy cuff is inflated.
Inability to understand English or cognitive impairment which impairs the patient's ability to follow directions.
Protocol
Baseline demographic information will be collected from each patient. This will include age, sex, height, weight, BMI, diagnosis, initial date of intubation and ICU admission, date of tracheostomy, date of admission to IICU, type and size of tracheostomy tube.
Baseline measurements of respiratory strength will be made in all patients. These will include vital capacity (VC), maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP). These are standard measurements, routinely done in the IICU. All measurements will be done with the patient in a head up or sitting position with the tracheostomy cuff inflated.
Measurement of cough strength will be done using an Air Zone Peak Expiratory Flow meter. This will be done with the patient in a head up or sitting position.
With the tracheostomy cuff inflated, the peak expiratory flow meter will be attached directly to the tracheostomy tube. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times. The first measurement will be discarded (learning curve). The peak expiratory flow will be recorded for the next three measurements. The three measurements should not deviate by more than 10%, and the best result will be recorded.
With the tracheostomy cuff deflated, a one-way valve will be attached to the tracheostomy tube. The patient will use a mouthpiece to connect to the peak expiratory flow meter. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times. The first measurement will be discarded (learning curve). The peak expiratory flow will be recorded for the next three measurements. The three measurements should not deviate by more than 10 %, and the best result will be recorded.
The patients will be randomized to start with either the tracheostomy cuff inflated or deflated.
At the end of the measurements, the patient will be returned to their usual care.
The entire study should take approximately ten minutes.
The investigators propose to study 20 consecutive adult patients in the IICU.
Data analysis
The best expiratory flow measurements will be averaged together with the tracheostomy cuff inflated and with the tracheostomy cuff deflated. The values will be compared using Student's T test. A p value < 0.05 will be considered significant.
- Conditions
- Mechanical Ventilator Weaning
- Being tested
- Tracheostomy cuff inflation., Tracheostomy cuff deflation
- Keywords
- Tracheostomy, weaning, respiratory failure, cough strength
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheostomy cuff inflation.Other
With the tracheostomy cuff inflated, the peak expiratory flow meter will be attached directly to the tracheostomy tube. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times.
Tracheostomy cuff deflationOther
With the tracheostomy cuff deflated, a one-way valve will be attached to the tracheostomy tube. The patient will use a mouthpiece to connect to the peak expiratory flow meter. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times
| Study group | Role | What they receive |
|---|---|---|
| Tracheostomy cuff inflated | Other | The tracheostomy cuff will be inflated. Receives: Other: Tracheostomy cuff inflation. |
| Tracheostomy cuff deflated | Other | The tracheostomy cuff will be deflated. Receives: Other: Tracheostomy cuff deflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak expiratory flow rate
peak flow rate during a cough
Measured: Twenty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Jacobsohn, MD, Study chair, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566512
- Sponsor's protocol ID
- B2015:068
- Status last verified
- Oct 2018
- First submitted
- 23 Jun 2015
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Daniel Martin A, Smith BK, Gabrielli A. Mechanical ventilation, diaphragm weakness and weaning: a rehabilitation perspective. Respir Physiol Neurobiol. 2013 Nov 1;189(2):377-83. doi: 10.1016/j.resp.2013.05.012. Epub 2013 May 18.
PubMed 23692928Frutos-Vivar F, Esteban A. Our paper 20 years later: how has withdrawal from mechanical ventilation changed? Intensive Care Med. 2014 Oct;40(10):1449-59. doi: 10.1007/s00134-014-3362-0. Epub 2014 Jul 23.
PubMed 25053247Hernandez G, Pedrosa A, Ortiz R, Cruz Accuaroni Mdel M, Cuena R, Vaquero Collado C, Garcia Plaza S, Gonzalez Arenas P, Fernandez R. The effects of increasing effective airway diameter on weaning from mechanical ventilation in tracheostomized patients: a randomized controlled trial. Intensive Care Med. 2013 Jun;39(6):1063-70. doi: 10.1007/s00134-013-2870-7. Epub 2013 Mar 8.
PubMed 23471512McKim DA, Hendin A, LeBlanc C, King J, Brown CR, Woolnough A. Tracheostomy decannulation and cough peak flows in patients with neuromuscular weakness. Am J Phys Med Rehabil. 2012 Aug;91(8):666-70. doi: 10.1097/PHM.0b013e31825597b8.
PubMed 22561386Heffner JE, Martin-Harris B. (2006) Care of the Mechanically Ventilated Patient with a Tracheostomy in Tobin MJ (Ed) Principles and Practice of Mechanical Ventilation 2nd edition (pp 847 - 875) McGraw-Hill
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cough Strength in Patients With Tracheostomies
- ClinicalTrials.gov ID
- NCT02566512
- Acronym / sponsor ID
- B2015:068
- Conditions
- Mechanical Ventilator Weaning
- Keywords
- Tracheostomy, weaning, respiratory failure, cough strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 2 Oct 2015 (estimated)
- 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 investigators propose to assess cough strength in patients undergoing spontaneous breathing trials in the Intermediate Intensive Care Unit (IICU) and compare their cough strength under two conditions,
- Tracheostomy cuff inflated: cough strength will be measured with the tracheostomy cuff inflated and the patient coughing through the tracheostomy tube.
- Tracheostomy cuff deflated: cough strength will be measured with the tracheostomy cuff deflated and the patient coughing around the tracheostomy tube, through their mouth..
The investigators hypothesize that patients will have a stronger cough when they can use their vocal cords.
Detailed description
When a patient has recovered from the initial respiratory insult which precipitated respiratory failure, the patient may need a prolonged period of time to wean completely from mechanical ventilation.
One method of weaning from mechanical ventilation involves having the patient breath spontaneously without the assistance of the ventilator. This is referred to as a spontaneous breathing trial. Over time, the duration of spontaneous breathing is gradually increased until the patient is able to breathe entirely on their own. Traditionally, the tracheostomy cuff has been kept inflated until the patient can breathe entirely on their own (2,3).
A recent study has assessed the effect of deflating the tracheostomy tube cuff on weaning from mechanical ventilation (4). Patients, who required prolonged mechanical ventilation and had a tracheostomy, were weaned using a T piece trial. They were randomized to two groups: the control group had the tracheostomy cuff kept inflated; the study group had the tracheostomy cuff deflated. The study group, with the cuff deflated, had a shorter time to weaning from the ventilator, fewer respiratory infections and improved swallowing. This was attributed to an increase in the effective airway diameter, which would decrease the resistive work of breathing. The authors did not comment on the effect cuff deflation may have on coughing and clearance of secretions.
It is postulated that patients can cough more effectively when he/she can use their vocal cords to generate a cough as opposed to coughing through a tracheostomy tube where the vocal cords are bypassed. It has been previously demonstrated that patients have a stronger cough after the tracheostomy tube has been removed as compared to when the tracheostomy tube is in place (5).
Patient population
The study group will include all adult patients in the IICU, on prolonged mechanical ventilation who are having spontaneous breathing trials as part of their weaning protocol.
Patients will be required to give written, informed consent.
Exclusion criteria
Any patient who has a leak around their tracheostomy tube when the tracheostomy cuff is inflated.
Inability to understand English or cognitive impairment which impairs the patient's ability to follow directions.
Protocol
Baseline demographic information will be collected from each patient. This will include age, sex, height, weight, BMI, diagnosis, initial date of intubation and ICU admission, date of tracheostomy, date of admission to IICU, type and size of tracheostomy tube.
Baseline measurements of respiratory strength will be made in all patients. These will include vital capacity (VC), maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP). These are standard measurements, routinely done in the IICU. All measurements will be done with the patient in a head up or sitting position with the tracheostomy cuff inflated.
Measurement of cough strength will be done using an Air Zone Peak Expiratory Flow meter. This will be done with the patient in a head up or sitting position.
With the tracheostomy cuff inflated, the peak expiratory flow meter will be attached directly to the tracheostomy tube. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times. The first measurement will be discarded (learning curve). The peak expiratory flow will be recorded for the next three measurements. The three measurements should not deviate by more than 10%, and the best result will be recorded.
With the tracheostomy cuff deflated, a one-way valve will be attached to the tracheostomy tube. The patient will use a mouthpiece to connect to the peak expiratory flow meter. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times. The first measurement will be discarded (learning curve). The peak expiratory flow will be recorded for the next three measurements. The three measurements should not deviate by more than 10 %, and the best result will be recorded.
The patients will be randomized to start with either the tracheostomy cuff inflated or deflated.
At the end of the measurements, the patient will be returned to their usual care.
The entire study should take approximately ten minutes.
The investigators propose to study 20 consecutive adult patients in the IICU.
Data analysis
The best expiratory flow measurements will be averaged together with the tracheostomy cuff inflated and with the tracheostomy cuff deflated. The values will be compared using Student's T test. A p value < 0.05 will be considered significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracheostomy cuff inflated | Other | Other: Tracheostomy cuff inflation.The tracheostomy cuff will be inflated. |
| Tracheostomy cuff deflated | Other | Other: Tracheostomy cuff deflationThe tracheostomy cuff will be deflated. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study group will include all adult patients in the IICU, on prolonged mechanical ventilation who are having spontaneous breathing trials as part of their weaning protocol.
Key exclusion criteria (2 listed)
- Any patient who has a leak around their tracheostomy tube when the tracheostomy cuff is inflated.
- Inability to understand English or cognitive impairment which impairs the patient's ability to follow directions.
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 |
|---|---|---|
| Tracheostomy cuff inflation.With the tracheostomy cuff inflated, the peak expiratory flow meter will be attached directly to the tracheostomy tube. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times. | Other | Tracheostomy cuff inflated |
| Tracheostomy cuff deflationWith the tracheostomy cuff deflated, a one-way valve will be attached to the tracheostomy tube. The patient will use a mouthpiece to connect to the peak expiratory flow meter. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times | Other | Tracheostomy cuff deflated |
Primary outcome
Peak expiratory flow rate
Time frame: Twenty minutes
peak flow rate during a cough
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Results publication: PubMed 23692928Daniel Martin A, Smith BK, Gabrielli A. Mechanical ventilation, diaphragm weakness and weaning: a rehabilitation perspective. Respir Physiol Neurobiol. 2013 Nov 1;189(2):377-83. doi: 10.1016/j.resp.2013.05.012. Epub 2013 May 18.
- Results publication: PubMed 25053247Frutos-Vivar F, Esteban A. Our paper 20 years later: how has withdrawal from mechanical ventilation changed? Intensive Care Med. 2014 Oct;40(10):1449-59. doi: 10.1007/s00134-014-3362-0. Epub 2014 Jul 23.
- Results publication: PubMed 23471512Hernandez G, Pedrosa A, Ortiz R, Cruz Accuaroni Mdel M, Cuena R, Vaquero Collado C, Garcia Plaza S, Gonzalez Arenas P, Fernandez R. The effects of increasing effective airway diameter on weaning from mechanical ventilation in tracheostomized patients: a randomized controlled trial. Intensive Care Med. 2013 Jun;39(6):1063-70. doi: 10.1007/s00134-013-2870-7. Epub 2013 Mar 8.
- Results publication: PubMed 22561386McKim DA, Hendin A, LeBlanc C, King J, Brown CR, Woolnough A. Tracheostomy decannulation and cough peak flows in patients with neuromuscular weakness. Am J Phys Med Rehabil. 2012 Aug;91(8):666-70. doi: 10.1097/PHM.0b013e31825597b8.
- Results publicationHeffner JE, Martin-Harris B. (2006) Care of the Mechanically Ventilated Patient with a Tracheostomy in Tobin MJ (Ed) Principles and Practice of Mechanical Ventilation 2nd edition (pp 847 - 875) McGraw-Hill
Related trials for Mechanical Ventilator Weaning
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruitingObservational study
Diaphragm Ultrasound and Rapid Shallow Breathing Index for Predicting Extubation Success
Ventilator Weaning, Respiratory Insufficiency
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Recruiting
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
Enrolling by invitation
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
Ventilated Patient in Intensive Care
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.
Eric Jacobsohn, MD study chair
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheostomy cuff inflation. and Tracheostomy cuff deflation in people with Mechanical Ventilator Weaning, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 17 Oct 2018. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak expiratory flow rate (time frame: Twenty minutes). 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 NCT02566512, which also lists 5 linked publications.
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 17 Oct 2018.