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临床试验/NCT05941923
NCT05941923尚未招募不适用

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

Baqiyatallah Medical Sciences University0 个研究点目标入组 100 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Mortality rate

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Triple blinding : Patients, respiratory critical care nurses, and data analyzers will be blinded to the allocation

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients with pregnancy and breastfeeding women
  • Patients at end-stage medical condition
  • Patients with planned withdrawal of treatment

结局指标

主要结局

Mortality rate

时间窗: through study completion, an average of 3 months

The primary outcome of this study will be to compare mortality rates between two study groups.

次要结局

  • Treatment failures(through study completion, an average of 3 months)

研究者

发起方
Baqiyatallah Medical Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir Vahedian-Azimi

Principal Investigator

Baqiyatallah Medical Sciences University

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