Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05688189
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2022-12-28
Brief Title:
Initial Temperature of High Flow Nasal Cannula
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Initial Temperature Setting of High Flow Nasal Cannula in Critically Ill Patients a Pragmatic Randomized Trial
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEST2022
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 31-34-37C or 34-37C could lead to a different comfort as compared to 37C as initial starting setting
The secondary aim is to assess the patients dryness and humidity level of the nose
We hypothesize that a gradual increase in temperature 31-34-37C or 34-37C could lead to a different comfort as compared to 37C as initial starting setting
The secondary aim is to assess the patients dryness and humidity level of the nose
Detailed Description:
This is a single-center parallel arm 111 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 patients level of hypoxia For the specific purpose of this study the humidification temperature will be set by the nurse based on the enrollment arm 37C vs 34-37C vs 31-34-37C rather than by clinical decision The 37C arm implies the setting of the temperature immediately at 37C The 34-37C arm implies the setting of the temperature at 34C and after 15 minutes at 37C The 31-34-37C arm implies setting the temperature initially at 31C after 15 minutes at 34C and after another 15 minutes at 37C After 30 minutes at 37C 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
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 patients level of hypoxia For the specific purpose of this study the humidification temperature will be set by the nurse based on the enrollment arm 37C vs 34-37C vs 31-34-37C rather than by clinical decision The 37C arm implies the setting of the temperature immediately at 37C The 34-37C arm implies the setting of the temperature at 34C and after 15 minutes at 37C The 31-34-37C arm implies setting the temperature initially at 31C after 15 minutes at 34C and after another 15 minutes at 37C After 30 minutes at 37C 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None