Respiratory Critical Care Nurse Training Program

Not Applicable

Not yet recruiting

• Conditions: Treatment Compliance; Morality
• Interventions: Other: respiratory critical care support

• Registration Number: NCT05941923
• Lead Sponsor: Baqiyatallah Medical Sciences University

Brief Summary

The goal of this clinical trial study is to evaluate the clinical effectiveness of respiratory critical care nurses (RCCN) in improving outcomes for critically ill patients who require admission to the intensive care units (ICUs). The main question it aims to answer is: What is the effect of the respiratory critical care nurse in improving outcomes for critically ill patients? Participants will consist of critically ill patients who will be randomly allocated in a 1:1 ratio into two groups: the intervention group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital, and the control group, who will receive only routine care.

Detailed Description

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 between November 22, 2023, and November 10, 2024. The aim of this study will to evaluate the clinical effectiveness of respiratory critical care nurses (RCCN) in improving outcomes for critically ill patients who require admission to the intensive care units (ICUs). Participants will consist of critically ill patients who will be randomly allocated in a 1:1 ratio into two groups: the intervention group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital, and the control group, who will receive only routine care

Study Timeline

• Study First Submitted: 2023-06-22
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-04
• Last Update Submitted: 2023-07-04
• Study First Posted: 2023-07-12
• Last Update Posted: 2023-07-12
• Study Start: 2023-11
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• They are at least 18 years old,
• Critically ill patients who need critical care,
• They have no history of heart disease, stroke, autoimmune disease, neuromuscular diseases, cancer, or cardio-respiratory arrest,
• They are willing to participate in the study.

Exclusion Criteria

• Patients with pregnancy and breastfeeding women
• Patients at end-stage medical condition
• Patients with planned withdrawal of treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	respiratory critical care support	The experimental group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital

Primary Outcome Measures

Name	Time	Method
Mortality rate	through study completion, an average of 3 months	The primary outcome of this study will be to compare mortality rates between two study groups.

Secondary Outcome Measures

Name	Time	Method
Treatment failures	through study completion, an average of 3 months	The secondary outcome will be the proportion of treatment failures, which is defined by a composite endpoint consisting of the need for non-invasive ventilation (NIV), intubation, or death