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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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 |
|
| Control group | No Intervention | No intervention group, who will receive only routine care without any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| respiratory critical care support | Other | Patients in the intervention group will be received respiratory critical care support |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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A randomized controlled clinical superiority trial with two-arm parallel group design
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Triple blinding : Patients, respiratory critical care nurses, and data analyzers will be blinded to the allocation
| 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 |