Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000917639
Ethics application status
Approved
Date submitted
30/07/2014
Date registered
27/08/2014
Date last updated
27/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cough Reflex after Intubation (CRAIn)
Scientific title
Recovery of Cough Following Extubation after Coronary Artery Bypass Grafting: A Prospective Study.
Secondary ID [1] 285081 0
Nil
Universal Trial Number (UTN)
Trial acronym
CRAIn
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intubation 292610 0
Dysphagia 292611 0
Coronary Artery Bypass Grafting 292612 0
Condition category
Condition code
Surgery 292926 292926 0 0
Other surgery
Cardiovascular 293103 293103 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants underwent cough reflex testing (CRT) before intubation and after extubation for coronary artery bypass grafting. This study was observational.
CRT is performed by asking the participant to inhale nebulised citric acid. The citric acid is presented via face mask. The participant is instructed to "try not to cough". If the participant produced a cough on 2 out of 3 trials their cough was considered present. Three concentrations of citric acid, 0.4, 0.8 and 1.2 mol/L, were interspersed with normal saline trials to establish each participant's baseline.
Baseline CRT was performed before surgery and follow-up CRT was performed within two hours of extubation and then every morning and evening until the participant had a present cough at baseline level, withdrew or was discharged from hospital.
Intervention code [1] 289920 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292789 0
Return of reflexive cough as measured by a cough present at baseline CRT level.
Timepoint [1] 292789 0
Within two hours after extubation and approximately every 12 hours after until cough returned
Secondary outcome [1] 309690 0
Nil
Timepoint [1] 309690 0
Nil

Eligibility
Key inclusion criteria
Adults undergoing coronary artery bypass grafting
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients having valve replacement, history of dysphagia, head and neck cancer or neurological condition, abnormal cough reflex at baseline

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study population is patients undergoing elective cardiothoracic surgery at Wellington Hospital. This is a single cohort observational study. With 100 participants the study will have 90% power to estimate the proportion of patients whose cough reflex has diminished with a measurement error of +/- 10% (Stata/IC 11.2, StataCorp LP, Texas, USA).
The average time post-extubation of each follow-up and the
percentage of participants with cough response present at baseline level at each follow-up will be calculated.Time to cough response present for each participant will be plotted using the Kaplan-Meier survival curve and log rank tests performed to evaluate for significance between groups with an a priori significance level set at .05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/01/2013
Actual
22/01/2013
Date of last participant enrolment
Anticipated
3/06/2013
Actual
8/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6260 0
New Zealand
State/province [1] 6260 0
Wellington

Funding & Sponsors
Funding source category [1] 289686 0
University
Name [1] 289686 0
University of Canterbury
Country [1] 289686 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Department of Communication Disorders
University of Canterbury
Private Bag 4800
CHRISTCHURCH 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 288381 0
Hospital
Name [1] 288381 0
Capital & Coast District Health Board
Address [1] 288381 0
Private Bag 7902
Riddiford Street
Newtown
Wellington 6242
Country [1] 288381 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291427 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 291427 0
1 The Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 291427 0
New Zealand
Date submitted for ethics approval [1] 291427 0
Approval date [1] 291427 0
10/12/2012
Ethics approval number [1] 291427 0
12/CEN/50

Summary
Brief summary
Participants undergoing CABG had a baseline cough reflex test (CRT) before surgery/intubation. The CRT was repeated within two hours of extubation. Participants with no change for their baseline had no further testing as cough was considered unchanged. Participants with absent cough were retested every morning and evening until baseline cough returned or the participant withdrew, was discharged or died. The cough reflex is an important airway clearance mechanism that protects the airway from aspiration. The researchers wanted to determine how long patients' cough is absent after intubation and if any variables are predictive of recovery.
Trial website
Trial related presentations / publications
Kallesen, M., Psirides, A. & Huckabee, ML. (2014, March). A Prospective Study of Cough Response to Nebulised Citric Acid following Ventilation for Elective Cardiac Surgery. Poster presented at the annual meeting of the Dysphagia Research Society, Nashville, TN.
Public notes

Contacts
Principal investigator
Name 50318 0
Ms Molly Kallesen
Address 50318 0
Level 10, Grace Neil Block
Wellington Hospital
Private Bag 7902
Wellington 6242
Country 50318 0
New Zealand
Phone 50318 0
6448062345
Fax 50318 0
Email 50318 0
[email protected]
Contact person for public queries
Name 50319 0
Ms Molly Kallesen
Address 50319 0
Level 10, Grace Neil Block
Wellington Hospital
Private Bag 7902
Wellington 6242
Country 50319 0
New Zealand
Phone 50319 0
6448062345
Fax 50319 0
Email 50319 0
[email protected]
Contact person for scientific queries
Name 50320 0
Ms Molly Kallesen
Address 50320 0
Level 10, Grace Neil Block
Wellington Hospital
Private Bag 7902
Wellington 6242
Country 50320 0
New Zealand
Phone 50320 0
6448062345
Fax 50320 0
Email 50320 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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