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Assessment of Cough Strength in Patients With Tracheostomies

Primary Purpose

Mechanical Ventilator Weaning

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tracheostomy cuff inflation.
Tracheostomy cuff deflation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mechanical Ventilator Weaning focused on measuring Tracheostomy, weaning, respiratory failure, cough strength

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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.

Sites / Locations

  • Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Tracheostomy cuff inflated

Tracheostomy cuff deflated

Arm Description

The tracheostomy cuff will be inflated.

The tracheostomy cuff will be deflated.

Outcomes

Primary Outcome Measures

Peak expiratory flow rate
peak flow rate during a cough

Secondary Outcome Measures

Full Information

First Posted
June 23, 2015
Last Updated
October 15, 2018
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02566512
Brief Title
Assessment of Cough Strength in Patients With Tracheostomies
Official Title
Assessment of Cough Strength in Patients With Tracheostomies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilator Weaning
Keywords
Tracheostomy, weaning, respiratory failure, cough strength

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tracheostomy cuff inflated
Arm Type
Other
Arm Description
The tracheostomy cuff will be inflated.
Arm Title
Tracheostomy cuff deflated
Arm Type
Other
Arm Description
The tracheostomy cuff will be deflated.
Intervention Type
Other
Intervention Name(s)
Tracheostomy cuff inflation.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tracheostomy cuff deflation
Intervention Description
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
Primary Outcome Measure Information:
Title
Peak expiratory flow rate
Description
peak flow rate during a cough
Time Frame
Twenty minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Jacobsohn, MD
Organizational Affiliation
University of Manitoba
Official's Role
Study Chair
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0Z2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23692928
Citation
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.
Results Reference
result
PubMed Identifier
25053247
Citation
Frutos-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 Reference
result
PubMed Identifier
23471512
Citation
Hernandez 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 Reference
result
PubMed Identifier
22561386
Citation
McKim 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 Reference
result
Citation
Heffner 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
Results Reference
result

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Assessment of Cough Strength in Patients With Tracheostomies

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