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Determining and comparing the effect of two airway humidification systems on respiratory parameters and arterial blood gases among head-trauma patients under the aggressive mechanical ventilation

Protocol summary

Study aim
Analyzing the effect of two airway humidification systems on respiratory parameters and arterial blood gases
Design
Cross over clinical trial
Settings and conduct
First, after identifying the patients that met the inclusion criteria, the head nurse of the department used numbers’ random tables (randomization) to divide the patients into two intervention groups of one and two. Then, the experienced nursing staff in the department, they were unaware of the objectives and results of the study (blinded study), used one of the airway humidifiers in the intervention group one for 30 minutes, and another airway humidifier for the intervention group two for 30 minutes. At the end of 30 minutes and having recorded the results (respiratory parameters and sending arterial blood gas samples and obtaining the result) in case of the lack of the risk factors for the patient, such as, dramatic and abnormal changes in results of arterial blood gases and in hemodynamic changes and in the absence of critical medical condition, the two humidification devices were interchanged in the intervention groups one and two, and they were used for 30 again, then the results were recorded as the first stage.
Participants/Inclusion and exclusion criteria
The patients with decreased level of consciousness after a trauma were admitted to the intensive care unit and were required invasive mechanical ventilation
Intervention groups
1. Based on the random number table, the eligible patients are assigned to the first group and one of the airway humidification devices is applied to the group, randomly. 2. The eligible patients are assigned to the second group randomly; one of the airway humidification devices is applied to the group, randomly
Main outcome variables
Respiratory parameters and parameters of arterial blood gas

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20180906040961N1
Registration date: 2018-10-17, 1397/07/25
Registration timing: na

Last update: 2018-10-17, 1397/07/25
Update count: 0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Ahmad Shahvandary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 8258
Email address
afgoudarzi@kums.ac.ir
Recruitment status
Not enough for processing
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2018-09-13, 1397/06/22
Trial completion date
2018-12-22, 1397/10/01
Scientific title
Determining and comparing the effect of two airway humidification systems on respiratory parameters and arterial blood gases among head-trauma patients under the aggressive mechanical ventilation
Public title
Analyzing the effect of two airway humidification systems on respiratory parameters and arterial blood gases
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with head trauma Patients with decreased level of consciousness Patients with mechanical ventilation Patients with no chest trauma Patients with no acute or chronic lung disease Patients with no history of acute or chronic kidney failure Not to be a brain death Not to be an organ transplant candidate The normality of the analysis of arterial blood gas results No hypothermia No bleeding in the airway
Exclusion criteria:
The patient’s parents’ unwillingness to participate in the study Patient with critical medical condition To be in a dying condition Brain death confirmation Organ transplant candidate Patient’s death
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 53
More than 1 sample in each individual
Number of samples in each individual: 4
Respiratory parameters and arterial blood gases after using each airway humidifiers
Randomization (investigator's opinion)
Randomized
Randomization description
12- After identifying the research samples, because of 8 beds in the unit, the patient are categorized into two groups by the chief nurse.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Determining and comparing the effect of two airway humidification systems on respiratory parameters and arterial blood gases among head-trauma patients under the aggressive mechanical ventilation

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Kermanshah University of Medical Sciences, Faculty of Nursing and Midwifery
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2018-07-23, 1397/05/01
Ethics committee reference number
IR.KUMS.RES.1397.235

Health conditions studied

1

Description of health condition studied
Effect of airway humidifiers on the respiratory parameters and arterial blood gases
ICD-10 code
X
ICD-10 code description
Diseases of the respiratory system

Primary outcomes

1

Description
The amount to respiratory parameters and parameters of arterial blood gases before using airway humidifiers
Timepoint
Immediately after starting intervention
Method of measurement
Using respiratory data of patient by ventilator and analysis of arterial blood gases

Secondary outcomes

1

Description
The amount to respiratory parameters and parameters of arterial blood gases after using airway humidifiers
Timepoint
30 minutes after using each airway humidifier
Method of measurement
Using respiratory data of patient by ventilator and analysis of arterial blood gases

Intervention groups

1

Description
Intervention group: The eligible patients of the study are divided into two groups – namely; the first and the second group- according to the random number table; one of the airway humidification devices is used randomly as an intervention for the first group, for 30 minutes, then the results are recorded and the second airway humidification software is used for 30 minutes and its results are recorded as well
Category
Treatment - Devices

2

Description
Intervention group: One of the airway humidification devices is used randomly for 30 minutes as an intervention for the eligible patients of the study who are placed in the second group according to the random number table, then the results are recorded and the second airway humidification software is used for 30 minutes and its results are recorded as well. In fact, we have an intervention group that is randomly divided into two groups, and both airway humidification devices are used randomly in a crossover manner, each for 30 minutes
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Ali Kosari
Street address
Farvardin Street, Neurosurgery ICU of Ahvaz Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6814674259
Phone
+98 83 3835 8258
Email
Ahmad.shahvandary@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
50- Dr. Fardi Najafi
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3835 8258
Email
Ahmad.shahvandary@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
54- Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ahmad Shahvandary
Position
M.Sc. Student in Nursing – ICU
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3835 8258
Email
Ahmad.shahvandary@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ahmad Khoshay
Position
Member of Nursing and Midwifery Faculty
Latest degree
Specialist
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3835 8258
Email
Ahmad.shahvandary@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ahmad Shahvandary
Position
M.Sc. Student in Nursing – ICU
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3835 8258
Email
akhoshay@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
All Right Reserved to Kermanshah University of Medical Sciences
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data will be shared after making the participants’ information unidentifiable
When the data will become available and for how long
It will be accessible six months after publishing results
To whom data/document is available
All researchers
Under which criteria data/document could be used
To use in the systematic review studies
From where data/document is obtainable
Kermanshah University of Medical Sciences
What processes are involved for a request to access data/document
Presenting request and receiving confirmation letter from university
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