The aim of this study is to evaluate the effect of humidifier therapy on postextubation complications in older people after coronary artery bypass surgery.
Design
Samples will be chosen from the patients admitted to Shaheed Rajaei hospital affiliated with Iran University of Medical Sciences. In this randomized controlled clinical trial, 80 patients will be randomly assigned to the experiment and control groups. The outcome assessor will be blinded to assigned the patients to groups.
Settings and conduct
This study will be done in intensive care unit of Shaheed Rajaei hospital affiliated with Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: age above of 60 years؛ the absence of any cognitive impairment؛ patients with first undergoing surgery coronary artery bypass؛ history of having respiratory disease or sore throat during the preceding week؛ lack of drug addiction؛ conscious patients؛ anesthesia duration between 4 and 6 hours؛ four to five hours operation time، having endotracheal tube between 6 to 8 hours after the end surgery.
Exclusion criteria included: patient with no cooperation ؛ physician disagreement؛ re-intubation tracheal tube after extubation؛ intubation more than 30 seconds؛ attempt for intubation more than once، traumatizing trachea، report of difficult intubation، death of patient during the study، daley of extubation process.
Intervention groups
The intervening group, receive ward routine care and also cool mist using nebulizer . The intervention group receive cool mist for 45 minutes before extubation and 45 minutes after extubation (90 min. overall).In control group, the 45 elderly patients receive only ward routine care .
Main outcome variables
Nausea, hoarseness, sore throat, and cough are measured immediately, 6,12,18, and 24 hrs. after extubation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110912007529N18
Registration date:2018-10-19, 1397/07/27
Registration timing:registered_while_recruiting
Last update:2018-10-19, 1397/07/27
Update count:0
Registration date
2018-10-19, 1397/07/27
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of humidifier therapy on postextubation complications in older people after coronary artery bypass surgery
Public title
The effect of humidifier therapy on postextubation complications in older people
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age above of 60 years،
the absence of any cognitive impairment،
patients with first undergoing surgery coronary artery bypass،
history of having respiratory disease or sore throat during the preceding week،
lack of drug addiction،
conscious patients،
Anesthesia duration between 4 to 6 hours،
four to five hours operation time،
having endotracheal tube between 6 to 8 hours after the end surgery،
Exclusion criteria:
Patient with no cooperation to end of study،
physician disagreement،
Re-intubation tracheal tube after extubation for any reason،
intubation more than 30 seconds،
attempt for intubation more than once،
traumatizing trachea (during intubation)،
report of difficult intubation (mallampati intubation score of higher than class ii )،
Death of patient during the study،
Daley of extubation process
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly assigned into two groups using permuted block randomization , Random numbers table will be used, Random allocation sequence will be determined using a computerized program.Opaque sealed sequentially numbered envelopes from number 1 to 80 will be used for allocation concealment
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor, staff nurses in the ICU and the statistical analyzer will be blind to patients’allocation of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Eligible patients will be selected through convenience sampling and will be randomly assigned into 2 groups using permuted block randomization with allocation ratio of 1:1. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 80 will be used for allocation concealment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shad University
Street address
Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2018-09-03, 1397/06/12
Ethics committee reference number
IR.SHAHED.REC.1397.043
Health conditions studied
1
Description of health condition studied
Nausea
ICD-10 code
R11.0
ICD-10 code description
Nausea
2
Description of health condition studied
Hoarseness
ICD-10 code
R49.0
ICD-10 code description
Dysphonia
3
Description of health condition studied
Cough
ICD-10 code
R05
ICD-10 code description
psychogenic cough
4
Description of health condition studied
Sore Throat
ICD-10 code
J02
ICD-10 code description
acute sore throat
Primary outcomes
1
Description
hoarseness
Timepoint
immediately after , 6,12,18, and 24 hrs. after extubation
Method of measurement
four-point scale
2
Description
nausea
Timepoint
immediately after , 6,12,18, and 24 hrs. after extubation
Method of measurement
four-point scale
3
Description
Cough
Timepoint
immediately after , 6,12,18, and 24 hrs. after extubation
Method of measurement
four-point scale
4
Description
sore throat
Timepoint
immediately after , 6,12,18, and 24 hrs. after extubation
Method of measurement
four-point scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The 45 elderly patients receive ward routine care and also cool mist using nebulizer. The intervention group receive cool mist for 45 minutes before extubation and 45 minutes after extubation (90 min. overall).
Category
Prevention
2
Description
Control group: The 45 elderly patients in control group receive only ward routine care.