Compilation, implementation and evaluation of a care program on the outcomes after endotracheal tube removal in patients hospitalized in the special care department of selected hospitals of Isfahan University of Medical Sciences in 1403
Design
Two group in randomized trial with control group in 60 patient
Settings and conduct
Before the rextubation , the patient will be seen at the bedside for 48 hours, 1, 6, 12, 24, 48 hours, and the degree of complications will be measured.
Participants/Inclusion and exclusion criteria
1-Patients aged 18 and above. 2-Patients who have been under mechanical ventilation for at least 48 hours.
Intervention groups
Investigating the patient's ability to cough and release secretions, dysphagia and stridor in patients after tracheal tube removal
Main outcome variables
out come: stridor, dysphagia, reintubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241222064129N1
Registration date:2025-01-19, 1403/10/30
Registration timing:registered_while_recruiting
Last update:2025-01-19, 1403/10/30
Update count:0
Registration date
2025-01-19, 1403/10/30
Registrant information
Name
Fatemeh sadat احمدی
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 990 8835
Email address
fat.sdt.ahmadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-04, 1403/10/15
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Implementation and Evaluation of a care program on outcomes of post extubation in patients admitted to the critical care unit.
Public title
Design, Implementation and Evaluation of a care program on outcomes of post extubation in patients admitted to the critical care unit.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1-Patients are 18 years old or older. 2-Patients who have been under mechanical ventilation for at least 48 hours.3.Patient that intubated due to each reason expect respiratory problem.
Exclusion criteria:
1.Dont like to continue the study2.The patient died3.unplanned extubation4.sever complications such as cardiorespiratory arrest, shock.
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
The random allocation of samples between two test and control groups will be done by minimization software, In this software you enter intervening variables on the results, samples will be assigned to the control and test groups. It means that the least significant difference in terms of intervening changes is between the two test and control groups.
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
Isfahan university of medical science
Street address
Hezar Jerib Ave, isfahan university of medical science
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-12-03, 1403/09/13
Ethics committee reference number
IR.MUI.NUREMA.REC.1403.142
Health conditions studied
1
Description of health condition studied
Extubation, post extubation stridor and dysphagia, reintubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
and Evaluation of a care program on outcomes of post extubation