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Japanese

Aug. 26, 2019

Sept. 06, 2023

jRCTs072190021

Study on prevention of hypercapnia by Nasal High Flow in patients undergoing endoscopic retrograde cholangiopancreatography during intravenous anesthesia

Study on prevention of hypercapnia by Nasal High Flow in patients undergoing endoscopic retrograde cholangiopancreatography during intravenous anesthesia

Mar. 31, 2023

80

patients who scheduled ERCP

completed

none

The primary outcome was the incidence of marked hypercapnia during an ERCP procedure under sedation observed in 1 patient (2.7%) in the NHF group and in 7 patients (18.4%) in the LFO group; statistical significance was found in the risk difference (-15.7%, p = 0.021) but not in the risk ratio (0.15, p = 0.066). In secondary outcome analysis, the mean time-weighted total PtcCO2 was 47.2 mmHg in the NHF group and 48.2 mmHg in the LFO group, with no significant difference (-0.97, p = 0.421). The duration of hypercapnia did not differ markedly between the two groups either and the occurrence of hypoxemia during an ERCP procedure under sedation was observed in 3 patients (8.1%) in the NHF group and 2 patients (5.3%) in the LFO group, with no significant difference (p = 0.674).

CONCLUSIONS: Respiratory support by NHF with room air did not reduce marked hypercapnia during ERCP under sedation relative to LFO. There was no significant difference in the occurrence of hypoxemia between the groups that may indicate an improvement of gas exchanges by NHF.

Aug. 31, 2023

May. 20, 2023

https://doi.org/10.1186/s12871-023-02125-w

No

NA

https://jrct.niph.go.jp/latest-detail/jRCTs072190021

Ayuse Takao

Nagasaki University Hspital

1-7-1 Sakamoto nagasaki Japan

+81-95-819-7713

ayuse@nagasaki-u.ac.jp

Ayuse Takao

Nagasaki University Hospital

1-7-1 Sakamoto Nagasaki Japan

+81-95-819-7713

ayuse@nagasaki-u.ac.jp

Complete

Aug. 26, 2019

Jan. 14, 2020
80

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1) Age: Adult patients whose age is between 20 and 85 years old at the time of obtaining consent
2) Gender: Any question
3) Hospitalization / outpatient: hospitalization only
4) Patients who have received sufficient explanation for participation in this study, and who have received sufficient written consent from the patient himself / herself with sufficient understanding.

1) Continuous administration of oxygen by nasal cannula (home oxygen therapy)
2) Patients who cannot breathe nose
3) Patients who cannot reduce or discontinue antithrombotic drugs on the day before the endoscope
4) Patients with a history of pneumothorax
5) Other patients who are determined to be inappropriate as research subjects by the principal investigator
6) Patients who are positive for the new coronavirus (SARS-CoV-2) PCR test

20age old over
85age old not

Both

Biliary disease

NHF intervention

1) Occurrence of marked hypercarbonemia showing maximum value of percutaneous carbon dioxide concentration over 60 mmHg (equivalent to PaCO2> 55 mmHg) during intravenous anesthesia
2) Area under curve (AUC) of percutaneous carbon dioxide concentration per unit time at intravenous anesthesia
3) Duration of moderate hypercarbonemia showing maximum value of 50mmHg or more (equivalent to PaCO2> 45mmHg) during percutaneous anesthesia with intravenous anesthesia
4) Occurrence of hypoxemia showing 90% or less of the value of percutaneous oxygen saturation during intravenous anesthesia

1) Anesthesia depth assessment (Ramsay scale)
2) Anesthesia dose

Fisher & Paykel Healthcare Limited
Not applicable
nagasaki University Clinical Research Committee
1-7-1 Sakamoto Nagasaki Japan, Nagasaki

+81-95-819-7229

gaibushikin@ml.nagasaki-u.ac.jp
Approval

none

History of Changes

No Publication date
7 Sept. 06, 2023 (this page) Changes
6 May. 14, 2021 Detail Changes
5 Nov. 24, 2020 Detail Changes
4 Oct. 30, 2020 Detail Changes
3 July. 14, 2020 Detail Changes
2 Oct. 25, 2019 Detail Changes
1 Aug. 26, 2019 Detail