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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05941923
Other study ID # Respiratory Nurse
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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