Clinical trial NCT05941923: Respiratory Critical Care Nurse Training Program
Official title: A Respiratory Critical Care Nurse Training Program for Countries Without Registered Respiratory Therapist: A Randomize Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Morality
Treatment Compliance
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical superiority trial with two-arm parallel group design
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Mortality rate
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Treatment failures
timeFrame: through study completion, an average of 3 months
Other outcomes:
measure: Rate of endotracheal intubation
timeFrame: through study completion, an average of 3 months
measure: Rate of non-invasive ventilation (NIV)
timeFrame: through study completion, an average of 3 months
measure: Rate of ventilator-associated pneumonia (VAP)
timeFrame: through study completion, an average of 3 months
measure: Rate of a two-point decrease based on the clinical World Health Organization (WHO) scale
timeFrame: through study completion, an average of 3 months
measure: Pre-ICU length of stay
timeFrame: through study completion, an average of 3 months
measure: ICU length of stay
timeFrame: through study completion, an average of 3 months
measure: Post-ICU length of stay
timeFrame: through study completion, an average of 3 months
measure: Functional oxygen saturation (SaO2)
timeFrame: through study completion, an average of 3 months
measure: partial pressure of oxygen (PaO2)
timeFrame: through study completion, an average of 3 months
measure: Oxygen saturation SpO2
timeFrame: through study completion, an average of 3 months
Locations:
Study officials:
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