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IRCT20241216064077N1 IRCT 2025-07-18 Bagheiat-allah University of Medical Sciences Designing, implementing and evaluating the Respiratory Critical Care Nurse Training Program Designing, implementing and evaluating the Respiratory Critical Care Nurse Training Program: Multimethod Study 2025-05-19 anticipated 100 Complete https://irct.ir/trial/80967 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, 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 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. N/A Unstable vital condition. Intervention 1: 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. Intervention 2: Control group: Patients in the control group will only receive routine medical care and will not receive RCCNs support. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available.
public Malihe Salimi
Baqiyatallah University of Medical Sciences, Mulla Sadra Ave
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 malihsalimi93@ajaums.ac.ir Bagheiat-allah University of Medical Sciences scientific Amir Vahedian Azimi
Baqiyatallah University of Medical Sciences, Mulla Sadra Ave
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 malihsalimi93@ajaums.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both Patients who are pregnant and breastfeeding Patients at end-stage medical condition, or patients with planned withdrawal of treatment Treatment - Other Treatment - Other 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. Control group: Patients in the control group will only receive routine medical care and will not receive RCCNs support. 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. Need for invasive or non-invasive ventilation. Timepoint: 72 hours after the intervention. Method of measurement: observation/Yes or No. Readmission. Timepoint: 72 hours after discharge from the intensive care unit. Method of measurement: Yes or NO. Bagheiat-allah University of Medical Sciences Approved 2024-10-20 Ethics committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Mulla Sadra Ave Tehran Tehran Iran (Islamic Republic of)