WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

NCT ID: NCT02436018

Last Updated: 2015-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-11-30

Brief Summary

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Low pulse oximetry is the most common adverse events during sedation for upper gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be evaluated.

Detailed Description

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Conditions

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Peptic Ulcer Gastric Cancer Esophagus Cancer Oesophagitis Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Oxygen(2L/min) supplied with nasal catheter

Group Type NO_INTERVENTION

No interventions assigned to this group

Nasopharyngeal airway group

Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator

Group Type EXPERIMENTAL

Nasopharyngeal airway without jet ventilator

Intervention Type DEVICE

Oxygen is supplied directly through WEI NASAL JET without jet ventilator

WEI NASAL JET group

Oxygen supplied through WEI NASAL JET with a manual jet ventilator

Group Type EXPERIMENTAL

WEI NASAL JET

Intervention Type DEVICE

Oxygen is supplied through WEI NASAL JET by a manual jet ventilator

Interventions

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WEI NASAL JET

Oxygen is supplied through WEI NASAL JET by a manual jet ventilator

Intervention Type DEVICE

Nasopharyngeal airway without jet ventilator

Oxygen is supplied directly through WEI NASAL JET without jet ventilator

Intervention Type DEVICE

Other Intervention Names

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Nasopharyngeal airway embedded with jet ventilation catheter

Eligibility Criteria

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Inclusion Criteria

* patients undergoing upper gastrointestinal endoscopy
* age over 18 years old
* Signed informed consent form

Exclusion Criteria

* a blood coagulation dysfunction or have a tendency of nose bleeding
* a clear diagnosis of heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
* a clear diagnosis of lung disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer)
* pregnant
* liver disease
* kidney disease
* increase in intracranial pressure
* emergency operation
* multiple trauma
* American Society of Anesthesiologists (ASA) Physical Status classification above IV
* with mouth, nose and throat infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pudong New Area People's Hospital

OTHER

Sponsor Role collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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diansan su

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diansan Su, Dr.

Role: STUDY_CHAIR

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Locations

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Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Diansan Su, Dr.

Role: CONTACT

+862168383702

Facility Contacts

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Xiaoqing Zhang, M.S.

Role: primary

Yi Qin, Master

Role: primary

+862168383702

Lizhi Li, M.S.

Role: primary

References

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Qin Y, Li LZ, Zhang XQ, Wei Y, Wang YL, Wei HF, Wang XR, Yu WF, Su DS. Supraglottic jet oxygenation and ventilation enhances oxygenation during upper gastrointestinal endoscopy in patients sedated with propofol: a randomized multicentre clinical trial. Br J Anaesth. 2017 Jul 1;119(1):158-166. doi: 10.1093/bja/aex091.

Reference Type DERIVED
PMID: 28974061 (View on PubMed)

Other Identifiers

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RenJiH-20150308

Identifier Type: -

Identifier Source: org_study_id

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