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
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
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
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
