UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037265
Receipt number R000042488
Scientific Title Effectiveness of combination of high flow nasal cannula therapy and body position on sleep disordered breathing after surgery; randomised cross-over trial
Date of disclosure of the study information 2019/07/08
Last modified on 2022/07/07 11:34:08

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Basic information

Public title

Effectiveness of combination of high flow nasal cannula therapy and body position on sleep disordered breathing after surgery; randomised cross-over trial

Acronym

Association between high flow nasal cannula therapy and body position in postoperative patients with obstructive sleep apnea

Scientific Title

Effectiveness of combination of high flow nasal cannula therapy and body position on sleep disordered breathing after surgery; randomised cross-over trial

Scientific Title:Acronym

Association between high flow nasal cannula therapy and body position in postoperative patients with obstructive sleep apnea

Region

Japan


Condition

Condition

Obstructive sleep apnea

Classification by specialty

Pneumology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare effectiveness of high flow nasal cannula therapy between supine and sitting postures on postoperative sleep disordered breathing

Basic objectives2

Others

Basic objectives -Others

To explore mechanisms of improvement of sleep disordered breathing with high flow nasal cannula therapy

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The difference between the Apnea-Hypopnea Index(AHI) in supine position and in sitting position

Key secondary outcomes

Changes of the pharyngeal area


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

supine

Interventions/Control_2

sitting

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Obstructive sleep apnea patients who have elective surgery under general anesthesia

Key exclusion criteria

1) patients with past history of head or neck surgery
2) patients with nasogastric tube
3) patients already using CPAP for obstructive sleep apnea
4) patients who have disorder of neck mobility
5) patients considered as high risk of aspiration
6) patients inappropriate for this research protocol

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Shiro
Middle name
Last name Isono

Organization

Graduate school of medicine school of medicine, Chiba university

Division name

Department of Anesthesiology

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN

TEL

043-222-7171

Email

ahna4624@chiba-u.jp


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Sakaguchi

Organization

Graduate school of medicine school of medicine, Chiba university

Division name

Department of Anesthesiology

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN

TEL

043-222-7171

Homepage URL


Email

ahna4624@chiba-u.jp


Sponsor or person

Institute

Chiba university

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate school of medicine school of medicine, Chiba university

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN

Tel

043-222-7171

Email

igaku-rinri@office.chiba-u.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 07 Month 08 Day


Related information

URL releasing protocol

https://pubs.asahq.org/anesthesiology/article/137/1/15/136244/Combination-Therapy-of-High-flow-Nasal

Publication of results

Published


Result

URL related to results and publications

https://pubs.asahq.org/anesthesiology/article/137/1/15/136244/Combination-Therapy-of-High-flow-Nasal

Number of participants that the trial has enrolled

23

Results

Compared to sole HFNC, additional intervention with upper body elevation significantly decreased AHI-flow by 11.5
events.hour-1 (1.7 to 21.4, 95% CI) (p=0.022).

Results date posted

2022 Year 07 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Background anthropometric and surgical characteristics did not differ between the groups. Preoperative apnea hypopnea index determined by both flow signal and Spo2 criteria was significantly greater in the flatbed/HOB30 group compared to the HOB30/flatbed group.

Participant flow

All participants underwent two preoperative sleep studies. First, at home on a flatbed and second, in the hospital on a HOB30 bed. Furthermore, two postoperative sleep studies were planned on N1 and N2 on the bed with different head-of-bed positions.

Adverse events

none

Outcome measures

The primary outcome of this study was the modified apnea hypopnea index measured by the sleep study based exclusively on the air flow signal without Spo2 criteria (AHI-flow). The secondary outcomes included all sleep study variables described above characterizing severity and nature of OSA.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 02 Month 18 Day

Date of IRB

2019 Year 02 Month 19 Day

Anticipated trial start date

2019 Year 07 Month 08 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 07 Month 04 Day

Last modified on

2022 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042488


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name