Assessment of Cough Strength in Patients With Tracheostomies

NCT02566512 | Completed

• 1 other identifier: B2015:068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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,

1. 1.Tracheostomy cuff inflated: cough strength will be measured with the tracheostomy cuff inflated and the patient coughing through the tracheostomy tube.
2. 2.Tracheostomy cuff deflated: cough strength will be measured with the tracheostomy cuff deflated and the patient coughing around the tracheostomy tube, through their mouth..

Conditions

Mechanical Ventilator Weaning

Keywords

Tracheostomy; weaning; respiratory failure; cough strength

Outcome Measures

Primary Outcomes (1)

• Peak expiratory flow rate

  peak flow rate during a cough

  Twenty minutes

Study Arms (2)

Tracheostomy cuff inflated

OTHER

The tracheostomy cuff will be inflated.

Other: Tracheostomy cuff inflation.

Tracheostomy cuff deflated

OTHER

The tracheostomy cuff will be deflated.

Other: Tracheostomy cuff deflation

Interventions

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 inflated

Tracheostomy cuff deflation OTHER

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

Tracheostomy cuff deflated

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3E 0Z2, Canada

Location

Related Publications (5)

• 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.

  PMID: 23692928 RESULT

• 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.

  PMID: 25053247 RESULT

• 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.

  PMID: 23471512 RESULT

• 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.

  PMID: 22561386 RESULT

• 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

  RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Eric Jacobsohn, MD

  University of Manitoba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: October 2, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

CA (1)