Respiratory Critical Care Nurse Training Program (RCCN Training)

A Respiratory Critical Care Nurse Training Program for Countries Without Registered Respiratory Therapist: A Randomize Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Morality; Treatment Compliance
• Intervention / Treatment: Other: respiratory critical care support

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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	Other: respiratory critical care support; Patients in the intervention group will be received respiratory critical care support
No Intervention: Control group; No intervention group, who will receive only routine care without any intervention.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failures	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	through study completion, an average of 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of endotracheal intubation	Rate of endotracheal intubation will be compare between two study groups	through study completion, an average of 3 months
Rate of non-invasive ventilation (NIV)	Rate of non-invasive ventilation (NIV) will be compare between two study groups	through study completion, an average of 3 months
Rate of ventilator-associated pneumonia (VAP)	Rate of ventilator-associated pneumonia (VAP) will be compare between two study groups	through study completion, an average of 3 months
Rate of a two-point decrease based on the clinical World Health Organization (WHO) scale	These changes will be measured from randomization to ICU discharge, which is defined as continuous and uneventful improvement without requiring additional respiratory support, from the date of inclusion until a two-point decrease in the clinical WHO scale. The clinical WHO measures the severity of a patient's hospitalization status on a seven-point ordinal scale as follows: (a) not hospitalized, capable of resuming normal activities, (b) not hospitalized but unable to resume normal activities, (c) hospitalized, no oxygen therapy, (d) hospitalized and requiring oxygen therapy, (e) hospitalized and requiring NIV or nasal high-flow oxygen, (f) hospitalized and requiring mechanical ventilation, (g) hospitalized and requiring mechanical ventilation (MV) with other organ support (vasopressors, renal replacement therapy, extracorporeal life support), and (h) dead.	through study completion, an average of 3 months
Pre-ICU length of stay	Pre-ICU length of stay in days will be compare between two study groups	through study completion, an average of 3 months
ICU length of stay	ICU length of stay in days will be compare between two study groups	through study completion, an average of 3 months
Post-ICU length of stay	Post-ICU length of stay in days will be compare between two study groups	through study completion, an average of 3 months
Functional oxygen saturation (SaO2)	SaO2 will be measured through an arterial blood gas (ABG) analysis and compare between two study groups	through study completion, an average of 3 months
partial pressure of oxygen (PaO2)	PaO2 will be measured through an arterial blood gas (ABG) analysis and compare between two study groups	through study completion, an average of 3 months
Oxygen saturation SpO2	SpO2 will be measured noninvasive using a pulse oximeter and compare between two study groups	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Baqiyatallah Medical Sciences University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Respiratory Nurse

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No