Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05688189
Other study ID # 6385
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2023
Est. completion date February 15, 2023

Study information

Verified date January 2023
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date February 15, 2023
Est. primary completion date February 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT02943863 - Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia N/A
Recruiting NCT05029167 - REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study) N/A
Completed NCT05112172 - Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m N/A
Recruiting NCT06110390 - High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients N/A
Completed NCT05677009 - Sustainable Preservation of Essential Oxygen Resources: A Phase 4 Crossover Study of the BUFEO System: SAVE O2 N/A
Recruiting NCT06037915 - Airway Interventions During Intravenous Anesthesia in Children Undergoing Direct Laryngoscopy for Surgical Procedures Using High Flow Nasal Versus Low Flow Oxygen. A Pilot Study.(Flowkid) Phase 4
Recruiting NCT04866342 - Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor N/A
Completed NCT02599246 - FiO2 in Chronic Obstructive Pulmonary Disease (COPD) Patient Normobaric O2 Versus NIV N/A
Completed NCT03607357 - High Flow Nasal Oxygen and Acute Left Heart Failure N/A
Recruiting NCT05401474 - Individualization Flow in Patients Treated With High Flow Nasal Therapy (iFLOW) N/A
Completed NCT01575327 - Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease N/A
Recruiting NCT04842253 - HFNC vs LFNC in Patients With AF Undergoing RFCA Under Deep Sedation. N/A
Completed NCT04177992 - Servo Controlled Oxygen Targeting Study N/A
Recruiting NCT05511636 - Comparing The Outcome Of High Flow Oxygen Versus Conventional Oxygen In Extubated Patients After Lung Resection. N/A
Completed NCT04363463 - Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress N/A
Terminated NCT04546568 - SCO2T (Servo vs. Servo) N/A
Completed NCT04824703 - Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients N/A
Completed NCT03431818 - Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants
Completed NCT04965844 - Closed-loop Oxygen Control for High Flow Nasal Therapy N/A