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临床试验/NCT05688189
NCT05688189已完成不适用

Initial Temperature Setting of High Flow Nasal Cannula in Critically Ill Patients: a Pragmatic Randomized Trial

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Patient comfort

研究概览

简要总结

In the literature there are no indication on which is the best setting of the humidification temperature at the start of treatment with high flow nasal cannula (HFNC) in intensive care unit (ICU). The primary objective of this study is to understand whether there is a difference between the approaches to the humidification temperature for initiating HFNC treatment based on the perceived comfort of ICU patients.

We hypothesize that a gradual increase in temperature (31-34-37°C or 34-37°C) could lead to a different comfort as compared to 37°C as initial starting setting.

The secondary aim is to assess the patient's dryness and humidity level of the nose.

详细描述

This is a single-center, parallel arm (1:1:1) interventional, non-pharmacological, pragmatic randomized trial. Adult patients who need HFNC treatment for clinical indication will be enrolled and receive a different initial temperature of humidification.

The treatment with HFNC will be carried out as it normally happens for clinical practice, that is the doctor will decide the oxygen concentration, from 21 to 100%, and the flow, from 30 to 60 liters / minute (usually 40-60 liters / minute), according to the patient's level of hypoxia. For the specific purpose of this study, the humidification temperature will be set by the nurse based on the enrollment arm (37°C vs 34-37°C vs 31-34-37°C) rather than by clinical decision. The 37°C arm implies the setting of the temperature immediately at 37°C. The 34-37°C arm implies the setting of the temperature at 34°C and after 15 minutes at 37°C. The 31-34-37°C arm implies setting the temperature initially at 31°C, after 15 minutes at 34°C and after another 15 minutes at 37°C. After 30 minutes at 37°C (target temperature), the patient will be asked to indicate his comfort level, using 5 score visual numerical scale (VNS) ranging from 1 (extreme discomfort) to 5 (best comfort) and the dyspnea level, using Borg scale ranging from 1 (no dyspnea) to 10 (extreme dyspnea). The level of dryness of the nose, HFNC settings and vital signs will also be recorded for each step.

The treatment with HFNC will be provided with the AIRVO 2 (trade mark) system (Fisher & Paykel Healthcare, New Zealand).

All study procedures will be performed at the ICU of the Fondazione IRCCS (Scientific Institute for Research, Hospitalization and Healthcare) Ca' Granda Ospedale Maggiore Policlinico.

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
Single (Investigator)

盲法说明

The principal investigator and the research nurse will be blinded to block size and number. The person responsible for data analysis will be provided an anonymized dataset, thus rendering him/her blinded to the type of treatment the patients received.

入排标准

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

入选标准

  • •Patients need HFNC as per clinical indication
  • •Patients without ICU delirium (CAM ICU negative)

排除标准

  • •Patients unable to express informed consent

研究组 & 干预措施

37 degree centigrade

Experimental

The 37°C arm implies the setting of the temperature immediately at 37°C.

干预措施: different starting temperature setting of HFNC (Device)

34-37 degree centigrade

Experimental

The 34-37°C arm implies the setting of the temperature at 34°C and after 15 minutes at 37°C.

干预措施: different starting temperature setting of HFNC (Device)

31-34-37 degree centigrade

Experimental

The 31-34-37°C arm implies setting the temperature initially at 31°C, after 15 minutes at 34°C and after another 15 minutes at 37°C.

干预措施: different starting temperature setting of HFNC (Device)

结局指标

主要结局

Patient comfort

时间窗: 30 minutes

Difference in comfort score among study arms at 37°C using visual numerical scale (VNS) ranging from 1 to 5

次要结局

  • Patient nose dryness(30 minutes)
  • Patient nose humidity(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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