Study Results
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Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2023-01-18
2023-02-15
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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37 degree centigrade
The 37°C arm implies the setting of the temperature immediately at 37°C.
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)
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.
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)
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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Patients without ICU delirium (CAM ICU negative)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Principal Investigators
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Alessandro Galazzi, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Locations
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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6385
Identifier Type: -
Identifier Source: org_study_id
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