Unique ID issued by UMIN | UMIN000019184 |
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Receipt number | R000021769 |
Scientific Title | Does High Flow Nasal Cannula placed before extubation with a fraction of inspired oxygen adjusted to a lower level prevent the formation of atelectasis after extubation: A prospective double-blinded randomized controlled trial. |
Date of disclosure of the study information | 2015/10/01 |
Last modified on | 2020/09/19 12:59:40 |
Does High Flow Nasal Cannula placed before extubation with a fraction of inspired oxygen adjusted to a lower level prevent the formation of atelectasis after extubation: A prospective double-blinded randomized controlled trial.
HFNC before extubation
Does High Flow Nasal Cannula placed before extubation with a fraction of inspired oxygen adjusted to a lower level prevent the formation of atelectasis after extubation: A prospective double-blinded randomized controlled trial.
HFNC before extubation
Japan |
Patients with mechanical ventilation in surgical intensive care unit.
Intensive care medicine |
Malignancy
NO
Study hypothesis
A placement of a High Flow Nasal Cannula before extubation with a fraction of inspired oxygen adjusted to a lower level can reduce the formation of atelectasis after extubation in surgical intensive care unit.
Efficacy
Exploratory
Pragmatic
Not applicable
Primary Outcome
The degree of atelectasis formation in one, three and five days after endtracheal extubation which are evaluated by blinded radiologists using the radiological atelectasis score.
Secondary Outcome
The incidence of the re-intubation and the initiation of of non-invasive positive airway ventilation within 5 days after extubation.
Duration of intensive care unit.
PaO2/FiO2 ratio in 15 minutes, 1 hour, 12 hours and 24 hours after extubation.
Degree of SpO2 just after extubation (one to 15 minutes).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Dose comparison
NO
NO
NO
Numbered container method
2
Treatment
Device,equipment |
High oxygen concentration Group
High Flow Nasal Cannula is placed just before extubation with a fraction of inspired oxygen of 100% and a current flow of 40L/minute. Patients are manually ventilated with bag using 100% oxygen before extubatioin.
High Flow Nasal Cannula is placed just before extubation with an adjusted fraction of inspired oxygen and a current flow of 40L/minute. The definition of adjusted oxygen concentration is as follows; PaO2/FiO2 ratio is measured at 15 minutes before extubation, and the value of adjusted oxygen concentration is calculated so that the PaO2 should become 100mmHg. The same fraction of inspired oxygen as the mechanical ventilator is used for manual ventilation with bag.
20 | years-old | <= |
Not applicable |
Male and Female
The adult patients in our surgical intensive care unit who are going to have endtrachal tubes extubated.
The patients who are not managed by anesthesiologists, those who undergo tracheotomy, those who use non-invasive positive ventilation after extubation and those who cannot use High Flow Nasal Cannula after extubation.
100
1st name | Kenzo |
Middle name | |
Last name | Ishii |
Fukuyama City Hospital
Department of Anesthesiology and Oncological Pain Medicine
721-8511
5-23-1, Zao-cho, Fukuyama city, Hiroshima, 721-8511 Japan
084-941-5151
keishii@city.fukuyama.hiroshima.jp
1st name | Kenzo |
Middle name | |
Last name | Ishii |
Fukuyama City Hospital
Department of Anesthesiology and Oncological Pain Medicine
721-8511
5-23-1, Zao-cho, Fukuyama city, Hiroshima, 721-8511 Japan
084-941-5151
keishii@city.fukuyama.hiroshima.jp
Fukuyama City Hospital
none
Self funding
Fukuyama city hospital, Ethics Committee
5-23-1, Zao-cho, Fukuyama city, Hiroshima, 721-8511 Japan
084-941-5151
shimin-byouin@city.fukuyama.hiroshima.jp
NO
福山市民病院(広島県)
2015 | Year | 10 | Month | 01 | Day |
Unpublished
Unpublished
Unpublished
51
The incidence of atelectasis formation that integrated 3 days data of RAS score (Group A:69.6%, H:81% p=0.38), RAS score of each day, and the rate of atelectasis formation at each day, had no significant difference. However, the P/F ratio measured 1 hour after extubation of Group A was significantly higher than that of Group H (360 vs. 265) in repeated measure ANOVA. The re-intubation ratio of Group A tended to be lower than that of Group H (0% vs. 14.3% p=0.06).
2019 | Year | 12 | Month | 03 | Day |
Delay expected |
Delay of analysis
Out of the 51 cases with consent, we analyzed 23 cases in Group A(Adjusted Oxygen Group), and 21 cases in Group H(High Oxygen Group).
We enrolled patients with mechanical ventilation for more than 12 hours in our surgical ICU. After deciding to extubate, we allocated patients into the adjusted low oxygen concentration Group (Group A) and high oxygen concentration Group (Group H). We used high flow nasal cannula (HFNC) at extubation. We used the value of FiO2 of Group A, which was calculated from the PaO2/FiO2 ratio measured 15 minutes before extubation. FiO2 of HFNC in Group H was set to 100% until the first analysis of P/F ratio after extubation.
None
The primary outcome was the incidence of atelectasis formation evaluated based on three chest X-rays taken on Day1, 3 and five after extubation. A radiological physician assessed the atelectasis formation using the radiological atelectasis score (RAS).
No longer recruiting
2015 | Year | 09 | Month | 24 | Day |
2015 | Year | 09 | Month | 24 | Day |
2015 | Year | 10 | Month | 01 | Day |
2017 | Year | 10 | Month | 07 | Day |
2017 | Year | 11 | Month | 01 | Day |
2017 | Year | 11 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2015 | Year | 09 | Month | 30 | Day |
2020 | Year | 09 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021769
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