UMIN-CTR Clinical Trial

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
Institute	Chiba university
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042488