NCT02436018

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

April 26, 2015

Last Update Submit

May 1, 2015

Conditions

Peptic UlcerGastric CancerEsophagus CancerOesophagitisHypoxia

Keywords

SedationLow pulse oximetryUpper gastrointestinal endoscopyWEI NASAL JET

Outcome Measures

Primary Outcomes (1)

  • Low pulse oximetry incidence

    Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary Outcomes (1)

  • Other adverse events

    Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Study Arms (3)

Control group

NO INTERVENTION

Oxygen(2L/min) supplied with nasal catheter

Nasopharyngeal airway group

EXPERIMENTAL

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

Device: Nasopharyngeal airway without jet ventilator

WEI NASAL JET group

EXPERIMENTAL

Oxygen supplied through WEI NASAL JET with a manual jet ventilator

Device: WEI NASAL JET

Interventions

WEI NASAL JETDEVICE

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

Also known as: Nasopharyngeal airway embedded with jet ventilation catheter
WEI NASAL JET group
Nasopharyngeal airway without jet ventilatorDEVICE

Oxygen is supplied directly through WEI NASAL JET without jet ventilator

Nasopharyngeal airway group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

NOT YET RECRUITING

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 28974061DERIVED

MeSH Terms

Conditions

Peptic UlcerStomach NeoplasmsEsophageal NeoplasmsEsophagitisHypoxia

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEsophageal DiseasesGastroenteritisSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Diansan Su, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    STUDY CHAIR

Central Study Contacts

Diansan Su, Dr.

CONTACT

+862168383702diansansu@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 26, 2015

First Posted

May 6, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

November 1, 2016

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

CN(3)