Morality, Treatment Compliance
Conditions
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
Interventions
OTHERrespiratory critical care support
Patients in the intervention group will be received respiratory critical care support
Sponsors
Baqiyatallah Medical Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Triple blinding : Patients, respiratory critical care nurses, and data analyzers will be blinded to the allocation
Intervention model description
A randomized controlled clinical superiority trial with two-arm parallel group design
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of ventilator-associated pneumonia (VAP) | through study completion, an average of 3 months | Rate of ventilator-associated pneumonia (VAP) will be compare between two study groups |
| Rate of a two-point decrease based on the clinical World Health Organization (WHO) scale | through study completion, an average of 3 months | 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. |
| Pre-ICU length of stay | through study completion, an average of 3 months | Pre-ICU length of stay in days will be compare between two study groups |
| ICU length of stay | through study completion, an average of 3 months | ICU length of stay in days will be compare between two study groups |
| Rate of endotracheal intubation | through study completion, an average of 3 months | Rate of endotracheal intubation will be compare between two study groups |
| Functional oxygen saturation (SaO2) | through study completion, an average of 3 months | SaO2 will be measured through an arterial blood gas (ABG) analysis and compare between two study groups |
| partial pressure of oxygen (PaO2) | through study completion, an average of 3 months | PaO2 will be measured through an arterial blood gas (ABG) analysis and compare between two study groups |
| Oxygen saturation SpO2 | through study completion, an average of 3 months | SpO2 will be measured noninvasive using a pulse oximeter and compare between two study groups |
| Post-ICU length of stay | through study completion, an average of 3 months | Post-ICU length of stay in days will be compare between two study groups |
| Rate of non-invasive ventilation (NIV) | through study completion, an average of 3 months | Rate of non-invasive ventilation (NIV) will be compare between two study groups |
Outcome results
None listed