The aim of this study was to compare effects of nebulized Budesonide and intravenous dexamethasone on tracheal tube cuff leak in intubated patients admitted to intensive care unit. The study included 270 patients admitted to ICU, aged between 18-65 years with the history of 48 hours intubation, not receiving any corticosteroid or non-steroid painkillers and absence of respiratory diseases such as asthma or chronic lung disease. These patients were randomly assigned to three groups through permuted block randomization and underwent the treatment with nebulized Budesonide, intravenous dexamethasone and normal saline according to the group they were assigned to. Interventions included: Intervention group 1: receiving a dosage of 1mg in 4cc of nebulized budesonide every 12 hours (for 48 hours), each time for 20 minutes and 2 ml intravenous normal saline every 8 hours as well. Intervention group 2: receiving a dosage of 8 mg intravenous dexamethasone per 8 hours for 48 hours and receiving 4ml normal saline every 12 hours through nebulizer as well. Control group: receiving 2 ml intravenous normal saline per 8 hours as well 4 ml normal saline per 12 hours through nebulizer. Finally, pulse oximetry and cardiac signs were monitored in these subjects at the start of the study (zero hours) and 12, 24, 36 and 48 hours after intubation and parameters such as Oxygen saturation, Mean Arterial Pressure, Heart Rate, and Cuff Leak Rate were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061734598N1
Registration date:2017-09-15, 1396/06/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-15, 1396/06/24
Registrant information
Name
Mehdi Heidari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 1605
Email address
jam@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator.
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-12-31, 1391/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nebulized Budesonide and Intravenous Dexamethasone on Tracheal Tube Cuff Leak in Intubated Patients Admitted to Intensive Care Unit
Public title
The Effects of Nebulized Budesonide and Dexamethasone on Patients Using Tube for Ventilation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the age range of 65-18 years; at least 48 hours of intubation; admission to intensive care unit and patient or his family’s consent to participate in the study.
Exclusion criteria: receiving corticosteroids; respiratory disease such as asthma or chronic lung disease; chronic consumption of NSAIDs.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
270
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences.
Street address
Isfahan University of Medical Sciences, Hezar jerib St., Isfahan, Iran.
City
Isfahan
Postal code
81746-73461
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUI.REC.1395.3.291
Health conditions studied
1
Description of health condition studied
Head trauma.
ICD-10 code
S07.9
ICD-10 code description
Crushing injury of head, part unspecified
2
Description of health condition studied
Loss of Consciousness.
ICD-10 code
R40.2
ICD-10 code description
Coma, unspecified
3
Description of health condition studied
Surgery.
ICD-10 code
T88.9
ICD-10 code description
Complication of surgical and medical care, unspecified
4
Description of health condition studied
Poisoning
ICD-10 code
T50.4
ICD-10 code description
Drugs affecting uric acid metabolism
Primary outcomes
1
Description
Oxygen saturation.
Timepoint
At the beginning of the study (zero hour) and 12, 24, 36 and 48 hours after intubation.
Method of measurement
Pulse oximetry device.
2
Description
Mean Arterial Pressure.
Timepoint
At the beginning of the study (zero hour) and 12, 24, 36 and 48 hours after intubation.
Method of measurement
Cardiac monitoring.
3
Description
Heart Rate.
Timepoint
At the beginning of the study (zero hour) and 12, 24, 36 and 48 hours after intubation.
Method of measurement
Cardiac monitoring.
4
Description
Cuff Leak Rate
Timepoint
At the beginning of the study (zero hour) and 12, 24, 36 and 48 hours after intubation.
Method of measurement
(Average volume of exhaust flow at 3 breaths with low current volume - Current volume of the device)/Current volume of the device =CLR
Secondary outcomes
empty
Intervention groups
1
Description
Control group: receiving 2 ml intravenous normal saline per 8 hours as well 4 ml normal saline per 12 hours through nebulizer.
Category
Treatment - Other
2
Description
Intervention group 2: receiving a dosage of 8 mg intravenous dexamethasone per 8 hours for 48 hours and receiving 4ml normal saline every 12 hours through nebulizer as well.
Category
Treatment - Other
3
Description
Intervention group 1: receiving a dosage of 1mg in 4cc of nebulized budesonide every 12 hours (for 48 hours), each time for 20 minutes and 2 ml intravenous normal saline every 8 hours as well.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive Care Unit in Alzahra hospital
Full name of responsible person
Dr. Saeed Abbasi
Street address
Anesthesiology department, University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Abbas Emami nejaad
Position
Resident in Anesthesia
Other areas of specialty/work
Street address
Anesthesiology department, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3668 0048
Fax
Email
abbas_emaminejad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Abbas Emami nejaad
Position
Resident in Anesthesia
Other areas of specialty/work
Street address
Anesthesiology department, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3668 0048
Fax
Email
abbas_emaminejad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Abbas Emami nejaad
Position
Resident in Anesthesia
Other areas of specialty/work
Street address
Anesthesiology department, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3668 0048
Fax
Email
abbas_emaminejad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)