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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000016810 |
Receipt No. | R000019509 |
Scientific Title | Comparison of Pentax-AWS Airway Scope and Airtraq for tracheal intubation in patients with obstructive sleep apnoea |
Date of disclosure of the study information | 2015/03/16 |
Last modified on | 2015/03/16 |
Basic information | ||
Public title | Comparison of Pentax-AWS Airway Scope and Airtraq for tracheal intubation in patients with obstructive sleep apnoea | |
Acronym | AWS vs Airtraq for OSA | |
Scientific Title | Comparison of Pentax-AWS Airway Scope and Airtraq for tracheal intubation in patients with obstructive sleep apnoea | |
Scientific Title:Acronym | AWS vs Airtraq for OSA | |
Region |
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Condition | ||
Condition | patients, who were diagnosed as having OSA, which was confirmed by polysomnography, but otherwise healthy were recruited into the study | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the efficacy of AWS and Airtraq in a single group of patients with OSA. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | intubation difficulty scale score |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -investigator(s) and assessor(s) are blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | in AWS group, the patient
was placed in the sniffing position, and then laryngoscopy and tracheal intubation were performed with Pentax-AWS Airway Scope. |
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Interventions/Control_2 | in Airtraq group, the patient
was placed in the sniffing position, and then laryngoscopy and tracheal intubation were performed with Airtraq optic laryngoscope. |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | adult patients (ASA physical status I or II) scheduled for elective uvulopalatopharyngoplasty (UPPP)
under general anaesthesia were included in this study. |
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Key exclusion criteria | 1, Patients who had loosened
teeth; 2, Patients who had a mouth opening of < 18mm, which is a minimum clearance for the disposable transparent blade; 3, Patients with any pathology in the neck, pharynx or larynx, a risk factor for aspiration of gastric contents; 4, Patients with a history of hypersensitivity to an anaesthetic drug; |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Third Military Medical University | ||||||
Division name | Department of Anaesthesiology, Southwest Hospital, | ||||||
Zip code | |||||||
Address | Gaotanyan road, Shapingba, Chongqing, China | ||||||
TEL | +81-086-23-68754197 | ||||||
cjandsh@tmmu.edu.cn |
Public contact | |||||||
Name of contact person |
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Organization | Third Military Medical University | ||||||
Division name | Department of Anaesthesiology, Southwest Hospital, | ||||||
Zip code | |||||||
Address | Gaotanyan road, Shapingba, Chongqing, China | ||||||
TEL | +81-086-23-68754197 | ||||||
Homepage URL | |||||||
cjandsh@tmmu.edu..cn |
Sponsor | |
Institute | Department of Anaesthesiology, Southwest Hospital, |
Institute | |
Department |
Funding Source | |
Organization | Department of Anaesthesiology, Southwest Hospital, |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019509 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |