Respiratory Critical Care Nurse Training Program

Morality Clinical Trial

— RCCN Training  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941923
• Other study ID #: Respiratory Nurse
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: November 2024

Study information

• Verified date: July 2023
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Morality
• Treatment Compliance

Intervention

Other:
• respiratory critical care support
Patients in the intervention group will be received respiratory critical care support

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of endotracheal intubation	Rate of endotracheal intubation will be compare between two study groups	through study completion, an average of 3 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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