Initial Temperature of High Flow Nasal Cannula (BEST/2022)

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

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.

Study Overview

• Status: Completed
• Conditions: Oxygen Therapy
• Intervention / Treatment: Device: different starting temperature setting of HFNC

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients unable to express informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 37 degree centigrade; The 37°C arm implies the setting of the temperature immediately at 37°C.	Device: different starting temperature setting of HFNC; The humidification temperature will be set based on the enrollment arm (37°C vs 34-37°C vs 31-34-37°C)
Experimental: 34-37 degree centigrade; The 34-37°C arm implies the setting of the temperature at 34°C and after 15 minutes at 37°C.	Device: different starting temperature setting of HFNC; The humidification temperature will be set based on the enrollment arm (37°C vs 34-37°C vs 31-34-37°C)
Experimental: 31-34-37 degree centigrade; 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.	Device: different starting temperature setting of HFNC; The humidification temperature will be set based on the enrollment arm (37°C vs 34-37°C vs 31-34-37°C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient comfort	Difference in comfort score among study arms at 37°C using visual numerical scale (VNS) ranging from 1 to 5	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient nose dryness	Difference in dryness score among study arms at 37°C using visual numerical scale (VNS) ranging from 1 to 5	30 minutes
Patient nose humidity	Difference in humidity score among study arms at 37°C using visual numerical scale (VNS) ranging from 1 to 5	30 minutes

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

General Publications

• Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, Goligher EC, Jaber S, Ricard JD, Rittayamai N, Roca O, Antonelli M, Maggiore SM, Demoule A, Hodgson CL, Mercat A, Wilcox ME, Granton D, Wang D, Azoulay E, Ouanes-Besbes L, Cinnella G, Rauseo M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17.
• Mauri T, Galazzi A, Binda F, Masciopinto L, Corcione N, Carlesso E, Lazzeri M, Spinelli E, Tubiolo D, Volta CA, Adamini I, Pesenti A, Grasselli G. Impact of flow and temperature on patient comfort during respiratory support by high-flow nasal cannula. Crit Care. 2018 May 9;22(1):120. doi: 10.1186/s13054-018-2039-4.
• Chikata Y, Izawa M, Okuda N, Itagaki T, Nakataki E, Onodera M, Imanaka H, Nishimura M. Humidification performance of two high-flow nasal cannula devices: a bench study. Respir Care. 2014 Aug;59(8):1186-90. doi: 10.4187/respcare.02932.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: HFNC, Patient Comfort, Temperature
• Other Study ID Numbers: 6385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No