Design, implementation and evaluation of the respiratory intensive care nurse training program
Design
Randomized with controlled, parallel-group, triple-blind, , phase 2 clinical trial on 100 patients. RAS software was used for randomization.
Settings and conduct
A randomized controlled clinical superiority trial with triple blinding and a two-arm parallel group design will be conducted at Baqiyatallah University of Medical Sciences in Tehran, Iran The participants will consist of critically ill patients who will be randomly allocated in a 1:1 ratio into two groups: Patients, respiratory intensive care nurses, and the statistician will be blinded to ensure impartiality and minimize allocation bias.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of at least 18 years; Admitted to the intensive care unit; suffering one of the types of respiratory problems; willingness to participate in the study.
Exclusion criteria: final stages of life; unwillingness to continue participation; history of neuromuscular diseases or cardiorespiratory arrest.
Intervention groups
Patients will be divided into two intervention or control groups based on random assignment according to the inclusion criteria. The intervention group will receive specialized respiratory care from respiratory care nurses from the time of admission to the intensive care unit until discharge from the intensive care unit, and the control group will receive only routine hospital care.
Main outcome variables
The primary outcome of this study will be a comparison of ICU-mortality rates between the two study groups. The secondary outcome will be the proportion of treatment failures, defined as a composite endpoint consisting of the need for non-invasive ventilation (NIV), intubation, or death at the time of ICU discharge.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241216064077N1
Registration date:2025-07-18, 1404/04/27
Registration timing:registered_while_recruiting
Last update:2025-07-18, 1404/04/27
Update count:0
Registration date
2025-07-18, 1404/04/27
Registrant information
Name
Malihe Salimi bani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 9001
Email address
malihsalimi93@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-19, 1404/02/29
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing, implementing and evaluating the Respiratory Critical Care Nurse Training Program: Multimethod Study
Public title
Designing, implementing and evaluating the Respiratory Critical Care Nurse Training Program
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are critically ill and require admission to the ICU will be eligible for enrollment if they meet the following criteria:
Age of at least 18 years old
Critical care requirement due to their illness
No history of heart disease, stroke, autoimmune disease, neuromuscular diseases, cancer, or cardiorespiratory arrest
Willingness to participate in the study
Exclusion criteria:
Patients who are pregnant and breastfeeding
Patients at end-stage medical condition, or patients with planned withdrawal of treatment
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience sampling will be used to enroll participants in the study. Randomization will be performed using blocks of four using SAS software by a statistician not involved in the study. Blocked randomization is used to balance the number of samples allocated to each study group to ensure that exactly equal numbers of participants are assigned to the intervention and control groups at successive time intervals. Four people will be assigned to the intervention group and then four people will be assigned to the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The allocation consignment will be carried out by the hospital clinical supervisor, who is not involved in the participant recruitment. Patients, RCCNs, and data analysts will be blinded to the allocation to ensure impartiality and minimize bias.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Mulla Sadra Ave
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2024-10-20, 1403/07/29
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.161
Health conditions studied
1
Description of health condition studied
Unstable vital condition
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ICU-mortality rates
Timepoint
Before the study, during the study, one month after the intervention
Method of measurement
Electronic health system, intensive care unit documentation, death certificate
Secondary outcomes
1
Description
Need for invasive or non-invasive ventilation
Timepoint
72 hours after the intervention
Method of measurement
observation/Yes or No
2
Description
Readmission
Timepoint
72 hours after discharge from the intensive care unit
Method of measurement
Yes or NO
Intervention groups
1
Description
Intervention group: All critically ill patients who meet the inclusion criteria (as mentioned in the trial population section) and referred to the Baqiyatallah Hospital ED will receive routine medical care. However, they will be assigned to either the intervention or control group based on random allocation. Patients in the intervention group will receive RCCNs support from admission to the ED until discharge from the hospital. Critical care nurses, whose job descriptions were determined after completing the research stages of a scoping study, contractual content analysis, and three Delphi rounds, manage all of the patient's respiratory needs and problems, including oxygen therapy, intubation if necessary, suction and respiratory physiotherapy, lung function testing, and ventilator settings. The RCCNs will manage all respiratory needs and problems, accompany patients during transfers from the ED to the ICU and general wards, and provide ongoing support.
Category
Treatment - Other
2
Description
Control group: Patients in the control group will only receive routine medical care and will not receive RCCNs support.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Malihe salimi
Street address
Baqiyatallah hospital, Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
malihsalimi93@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Abbas Ali Emani Folladi
Street address
Baqiyatallah University of Medical Sciences ,Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
malihsalimi93@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Malihe Salimi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Baqiyatallah University of Medical Sciences, Mulla Sadra Ave
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
malihsalimi93@ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Amir Vahedian Azimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Baqiyatallah University of Medical Sciences, Mulla Sadra Ave
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
malihsalimi93@ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Malihe Salimi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Baqiyatallah University of Medical Sciences, Mulla Sadra Ave
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
malihsalimi93@ajaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available