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Completed

NCT Number: NCT05688189

Initial Temperature of High Flow Nasal Cannula

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients unable to express informed consent

Treatment and study plan

different starting temperature setting of HFNC

Device

The humidification temperature will be set based on the enrollment arm (37°C vs 34-37°C vs 31-34-37°C)

Primary outcomes

  1. Patient comfort

    Time frame: 30 minutes

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

Secondary outcomes

  1. Patient nose dryness

    Time frame: 30 minutes

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

  2. Patient nose humidity

    Time frame: 30 minutes

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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Acronym: BEST/2022

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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