Comparing the clinical outcomes of the T-piece and pressure support ventilation among patients with head trauma: a randomized controlled clinical trial
Compare the clinical outcomes of T-piece and pressure support ventilation among patients with traumatic brain injury.
Design
The present study was a randomized clinical trial with control group on 60 patients
Settings and conduct
This study is performed in the intensive care unit of Shahid Rajaee hospital in Qazvin. There was no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: at least 18 years old of age; Patients undergoing mechanical ventilation for more than 48 hours and less than 2 weeks; Glasgow coma scale (GCS) equal to or greater than 9; Normal electrolytes; Hemoglobin greater than 8; Body temperature less than 38.5. Non-inclusion criteria: Chronic cardiopulmonary problems; Use of vasoactive drugs; Spinal cord injury; Seizure; Decreased consciousness due to toxicity.
Intervention groups
Intervention group: T-piece group. Patients are weaned from the mechanical ventilation device and will be placed under ventilation with T-piece for 2 hours. If they tolerate spontaneous breathing, successful weaning will be occurred and otherwise it will be failure in weaning.
Control group: Pressure support ventilation group. Patients will be placed on spontaneous ventilation mode with pressure support of less than 8 cm of water. If they tolerate spontaneous breathing, successful weaning will be occurred and otherwise it will be failure in weaning.
Main outcome variables
Weaning of mechanical ventilation, extubation, length of mechanical ventilation, length of hospital stay, mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171212037848N3
Registration date:2020-04-06, 1399/01/18
Registration timing:retrospective
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Sareh Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
s.mohammadi@qms.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the clinical outcomes of the T-piece and pressure support ventilation among patients with head trauma: a randomized controlled clinical trial
Public title
Investigating the Effect of Using the T-pieace Method among patients with head trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients hospitalized in intensive care units
Received mechanical ventilation for at least 48 hours and at most two weeks
Age of more than 18 years old
Glasgow Coma Scale (GCS) score of more than 9
Normal electrolyte levels
Hemoglobin greater than 8
Body temperature less than 38.5
Exclusion criteria:
chronic disease and cardiopulmonary problem
intake of vasoactive medications
spinal cord injury
history of convulsion
Poisoning-induced altered consciousness
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly allocated to the intervention and a control groups through block randomization method using blocks of size 4.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar boulevard
City
Qazvin
Province
Qazvin
Postal code
1531534199
Approval date
2020-03-19, 1398/12/29
Ethics committee reference number
IR.QUMS.REC.1398.388
Health conditions studied
1
Description of health condition studied
Head trauma patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Weaning of mechanical ventilation
Timepoint
During the hospital stay
Method of measurement
Examine the vital signs of the patient
2
Description
Extubation
Timepoint
During the hospital stay
Method of measurement
Examine the vital signs of the patient
3
Description
Duration of mechanical ventilation
Timepoint
After the weaning of mechanical ventilation
Method of measurement
Number of days the patient is under mechanical ventilation
4
Description
Length of hospital stay
Timepoint
Weaning time until hospital discharge
Method of measurement
Number of days of hospitalization
5
Description
Death rate
Timepoint
Time of death
Method of measurement
Number of deaths in two groups
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients in the intervention group were placed on the T-piece for two hours. Patients who did not tolerate spontaneous breathing were reconnected to MV , were considered as unsuccessful weaning, and were subjected to another weaning attempt 24 hours after the first attempt. Spontaneous breathing toleration criteria were respiratory rate of less than 35 per minutes, heart rate of less than 140 beats per minute, arterial oxygen saturation of more than 90%, arterial partial oxygen pressure of more than 60 mm Hg, and no symptom of increased respiration workload such as sweating, dyspnea, and use of accessory respiratory muscles . Patients who fulfilled the criteria of spontaneous breathing for two hours were considered as successful weaning and were subjected to extubation. After extubation, patients who did not need re-intubation for 48 hours were considered as successful extubation
Category
Treatment - Other
2
Description
Control group: In the control group, patients who fulfilled weaning criteria were placed on pressure support ventilation (PSV) with a pressure support of less than 8 mm Hg. If patients tolerated spontaneous breathing for two hours were considered as successful weaning and were subjected to extubation; otherwise, they were considered as unsuccessful weaning and placed on synchronized intermittent mandatory ventilation (SIMV). Patients with successful weaning and extubation were considered as successful extubation if they did not need re-intubation during the first 48 hours after extubation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Sareh Mohammadi
Street address
Shahid Bahonar boulevard
City
Qazvin
Province
Qazvin
Postal code
3441734313
Phone
+98 28 3289 9470
Email
sareh_mohammadi@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Emamjomeh
Street address
Bahonar boulevard
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Sareh Mohammadi
Position
MSc in Nursing and Intensive Care
Latest degree
Master
Other areas of specialty/work
Others
Street address
Bahonar boulevard
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
sareh_mohammadi@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sareh Mohammadi
Position
Master's degree nursing specialist
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar boulevard
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
Email
s.mohammadi@qms.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sareh Mohammadi
Position
Master's degree nursing specialist
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar boulevard
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
Email
s.mohammadi@qms.ac.ir
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