Initial Temperature of High Flow Nasal Cannula

NCT05688189 | Completed

• 1 other identifier: 6385
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oxygen Therapy

Keywords

HFNC, Patient Comfort, Temperature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient nose dryness

  30 minutes

• Patient nose humidity

  30 minutes

Study Arms (3)

37 degree centigrade

EXPERIMENTAL

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

Device: different starting temperature setting of HFNC

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.

Device: different starting temperature setting of HFNC

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.

Device: different starting temperature setting of HFNC

Interventions

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)

31-34-37 degree centigrade; 34-37 degree centigrade; 37 degree centigrade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients unable to express informed consent

Sponsors & Collaborators

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

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (4)

• 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.

  PMID: 29743098 BACKGROUND

• 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.

  PMID: 33201321 BACKGROUND

• 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.

  PMID: 24368861 BACKGROUND

• Galazzi A, Gambazza S, Binda F, Dossena C, Cislaghi A, Adamini I, Palese A, Grasselli G, Laquintana D. The starting temperature of high-flow nasal cannula and perceived comfort in critically ill patients: A pragmatic randomized controlled trial. Nurs Crit Care. 2024 Nov;29(6):1601-1609. doi: 10.1111/nicc.13159. Epub 2024 Sep 18.

  PMID: 39293494 DERIVED

Study Officials

• Alessandro Galazzi, PhD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 18, 2023
• Study Start: January 18, 2023
• Primary Completion: February 6, 2023
• Study Completion: February 15, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)