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Comparing the Effects of Oral Caffeine and Medroxyprogesterone on Improving Respiratory Function in Traumatic Brain Injury Patients Under Mechanical Ventilation

Protocol summary

Study aim
Comparing the Effects of Oral Caffeine and Medroxyprogesterone on Improving Respiratory Function in Traumatic Brain Injury Patients Under Mechanical Ventilation
Design
A clinical trial with three parallel groups of control and intervention, triple-blind, randomized, is performed on 105 patients with traumatic brain injury. Patients are selected using a convenience sampling method. Then, using colored cards, they are assigned to three intervention and control groups.
Settings and conduct
Patients with traumatic brain injuries hospitalized in Khatam Anbia Hospital Zahedan are divided into three groups using a lottery. Basic information on respiratory function and arterial blood gas analysis is measured and recorded in the data collection form. Then, in the first intervention group, tablet caffeine 200 mg BD, in the second intervention group, tablet medroxyprogesterone 5 mg BD, and in the control group, placebo is gavage through a nasogastric tube. The gavage solutions are prepared by one of the researchers and then given to a nurse who is unaware of the type of solution and patient grouping. If the patients are not extubated, the medication gavage will continue for up to 10 days.
Participants/Inclusion and exclusion criteria
18 years old, Mechanical ventilation for at least 4 days, Consciousness level based on GCS scale ≥5
Intervention groups
In the first intervention group, tablet caffeine 200 mg BD, in the second intervention group, tablet medroxyprogesterone 5 mg BD and in the control group placebo is gavage through the nasogastric tube.
Main outcome variables
Number and volume of spontaneous breaths

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181028041484N2
Registration date: 2024-11-07, 1403/08/17
Registration timing: prospective

Last update: 2024-11-07, 1403/08/17
Update count: 0
Registration date
2024-11-07, 1403/08/17
Registrant information
Name
Aliakbar Keykha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2481
Email address
aliakbar.keykha@zaums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Oral Caffeine and Medroxyprogesterone on Improving Respiratory Function in Traumatic Brain Injury Patients Under Mechanical Ventilation
Public title
Investigation of the Effects of Oral Caffeine and Medroxyprogesterone on Improving Respiratory Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years old Mechanical ventilation through an endotracheal tube for at least 4 days Consciousness level based on GCS scale ≥5
Exclusion criteria:
Heart failure Renal failure Liver failure
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method is used to place patients in each control group and interventions one and two. First, based on the sample size, 105 cards are prepared in three different colors and placed in a box that cannot be seen inside. Then a lottery is drawn to allocate each of the cards to the three desired groups. Therefore, after each patient enters the study, a card is removed from the box, and based on the color of the card, intervention one or two is placed in the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
For blinding, prescription drugs and placebo with similar volume and appearance are prepared by the researcher and given to a nurse for gavage, who is unaware of the grouping of patients. The respiratory function data of the patients is also collected and recorded by the same nurse. To blind the statistician for data analysis, control, and intervention groups are also entered as code in spss software.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences ethical committee
Street address
Zahedan, Persian golf Blvd.,Doctor hesabi Square,Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
05431125000
Approval date
2024-09-15, 1403/06/25
Ethics committee reference number
IR.ZAUMS.REC.1403.247

Health conditions studied

1

Description of health condition studied
Traumatic brain injury
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Number of spontaneous breathing
Timepoint
Before the start of the intervention and after the intervention daily until the successful weaning from the ventilator or a maximum of 10 days.
Method of measurement
It is measured by the ventilator

2

Description
Volume of spontaneous breathing
Timepoint
Before the start of the intervention and after the intervention daily until the successful weaning from the ventilator or a maximum of 10 days
Method of measurement
It is measured by the ventilator

3

Description
Lung compliance
Timepoint
Before the start of the intervention and after the intervention daily until the successful weaning from the ventilator or a maximum of 10 days.
Method of measurement
Lung compliance is calculated by dividing volume by pressure. Its value is measured by the ventilator.

4

Description
Negative inspiratory force
Timepoint
Before the start of the intervention and after the intervention daily until the successful weaning from the ventilator or a maximum of 10 days
Method of measurement
It is measured by the ventilator.

5

Description
Rapid shallow breathing index (RSBI)
Timepoint
Before the start of the intervention and after the intervention daily until the successful weaning from the ventilator or a maximum of 10 days.
Method of measurement
It is calculated by dividing the tidal volume by the respiratory rate. Its value is measured by the ventilator.

6

Description
Duration of mechanical ventilation
Timepoint
Time to separate the patient from the ventilator and extubation of patients.
Method of measurement
Counting the number of days that patients were ventilated by a ventilator.

7

Description
Success of weaning from mechanical ventilation
Timepoint
From the time of endotracheal tube removal to 48 hours later.
Method of measurement
Patients who do not require re-intubation and mechanical ventilation until 48 hours after tracheal tube removal are considered successfully weaned from the ventilator.

8

Description
Level of consciousness
Timepoint
Before the start of the intervention and after the intervention daily until the successful weaning from the ventilator or a maximum of 10 days.
Method of measurement
The patient's level of consciousness is measured by the Glasgow Coma Scale (GCS).

9

Description
Arterial blood gas analysis
Timepoint
Before the start of the intervention and after the intervention daily until the successful weaning from the ventilator or a maximum of 10 days.
Method of measurement
A blood sample is taken from the patient's artery with a heparinized syringe and the gas values ​​are measured by a blood gas analyzer.

10

Description
The ratio of arterial oxygen pressure to inspiratory oxygen fraction
Timepoint
Before the start of the intervention and after the intervention daily until the successful weaning from the ventilator or a maximum of 10 days.
Method of measurement
It is calculated by dividing the pressure of arterial oxygen by the fraction of inspired oxygen.

11

Description
Hemodynamic variables
Timepoint
Before the start of the intervention and after the intervention daily until the successful weaning from the ventilator or a maximum of 10 days.
Method of measurement
Patient's hemodynamic variables are measured by Sadat company's bedside monitoring.

Secondary outcomes

1

Description
Duration of hospitalization in the intensive care unit
Timepoint
At the end of the study (when the patient was discharged from the intensive care unit)
Method of measurement
Counting the number of days from the time of admission to the time of discharge of the patient from the intensive care unit

Intervention groups

1

Description
Intervention group: In the first intervention group, after the physical conditions were stable and the necessary surgeries were performed, on the fourth day of hospitalization in the intensive care unit, 200 mg caffeine tablets with 20 cc of water were administered through a nasogastric tube. Caffeine gavage continues until the patient is weaned from the ventilator or up to 10 days. Respiratory function variables measured by the ventilator, arterial blood gas analysis, and patient hemodynamic variables are measured and recorded daily.
Category
Treatment - Drugs

2

Description
Intervention group: In the second intervention group, after the physical conditions were stable and the necessary surgeries were performed, on the fourth day of hospitalization in the intensive care unit, 5 mg Medroxyprogesterone tablets with 20 cc of water were administered through a nasogastric tube. Medroxyprogesterone gavage continues until the patient is weaned from the ventilator or up to 10 days. Respiratory function variables measured by the ventilator, arterial blood gas analysis, and patient hemodynamic variables are measured and recorded daily.
Category
Treatment - Drugs

3

Description
Control group: In this group, at the same time as intervention groups 1 and 2, only 20 cc of water is gavage. Then, changes in respiratory function measured by the ventilator, arterial blood gas analysis, and hemodynamic variables of the patient are measured and recorded daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital, Zahedan University of Medical Sciences
Full name of responsible person
Aliakbar Keykha
Street address
Faculty of Nursing and Midwifery, Mashahir Square, Health Blvd., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
aliakbar.keykha@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ebrahim Kord
Street address
Zahedan, Persian Gulf Blvd., Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2116
Email
zaums.research@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Aliakbar Keykha
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zahedan behdasht Ave., mashahir Square, Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
Email
aliakbar.keykha@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Aliakbar Keykha
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zahedan behdasht Ave., mashahir Square, Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
Email
aliakbar.keykha@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Aliakbar Keykha
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zahedan behdasht Ave., mashahir Square, Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
Email
aliakbar.keykha@zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All respiratory function data of patients are collected without personal information and sent to other researchers by email upon request.
When the data will become available and for how long
It is possible to send patients' information after the publication of the article of this project (end of 2025).
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of data for research and therapeutic purposes is permitted.
From where data/document is obtainable
Faculty of Nursing and Midwifery, Behdash Blv, Zahedan aliakbar.keykha@zaums.ac.ir or aliakbar.keykha@gmail.com
What processes are involved for a request to access data/document
To access the information, you must first send your request to me via email. After receiving the request, I will make the necessary arrangements with the Vice President of Research and Technology of Zahedan University of Medical Sciences and if there is no legal prohibition, I will send the data to you via email.
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