Peptic UlcerNCT02436018
WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy
A study testing WEI NASAL JET and Nasopharyngeal airway without jet ventilator in people with Peptic Ulcer and Gastric Cancer, run by RenJi Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer, Gastric Cancer, Esophagus Cancer
- What is being tested?
- WEI NASAL JET and Nasopharyngeal airway without jet ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing upper gastrointestinal endoscopy
- age over 18 years old
- Signed informed consent form
Who cannot join
- 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
Show all 11Show fewer
- increase in intracranial pressure
- emergency operation
- multiple trauma
- American Society of Anesthesiologists (ASA) Physical Status classification above IV
- with mouth, nose and throat infection
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Xiaoqing Zhang, M.S., xq_820175@163.com
- Recruiting
Renji hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Yi Qin, Master, +862168383702, 15921180801@163.com
Diansan Su, Dr.
- Not yet recruiting
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality
Lizhi Li, M.S., Fmlilizhi@sina.com.cn
About this study
Official title: Safety and Efficacy Evaluation of The Nasopharyngeal Airway Embedded With Jet Ventilation Catheter(WEI NASAL JET) Applied for The Sedation of Outpatient Upper Gastrointestinal Endoscopy
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.
- Conditions
- Peptic Ulcer, Gastric Cancer, Esophagus Cancer, Oesophagitis, Hypoxia
- Being tested
- WEI NASAL JET, Nasopharyngeal airway without jet ventilator
- Keywords
- Sedation, Low pulse oximetry, Upper gastrointestinal endoscopy, WEI NASAL JET
- Medical subject headings
- Peptic Ulcer, Stomach Neoplasms, Esophageal Neoplasms, Esophagitis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEI NASAL JETDevice
Also called Nasopharyngeal airway embedded with jet ventilation catheter
Oxygen is supplied through WEI NASAL JET by a manual jet ventilator
Nasopharyngeal airway without jet ventilatorDevice
Oxygen is supplied directly through WEI NASAL JET without jet ventilator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Nasopharyngeal airway without jet ventilator |
| WEI NASAL JET group | Experimental | Oxygen supplied through WEI NASAL JET with a manual jet ventilator Receives: Device: WEI NASAL JET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low pulse oximetry incidence
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes (1)
Other adverse events
The adverse events according to the Adverse event reporting tool of the world SIVA International Sedation Task Force during upper gastrointestinal endoscopy will be recorded. Adverse events associated with jet ventilation also be recorded.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
- Investigators
- Diansan Su, Dr., Study chair, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436018
- Sponsor's protocol ID
- RenJiH-20150308
- Status last verified
- May 2015
- First submitted
- 26 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28974061
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of The Nasopharyngeal Airway Embedded With Jet Ventilation Catheter(WEI NASAL JET) Applied for The Sedation of Outpatient Upper Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT02436018
- Acronym / sponsor ID
- RenJiH-20150308
- Conditions
- Peptic Ulcer, Gastric Cancer, Esophagus Cancer, Oesophagitis, Hypoxia
- Keywords
- Sedation, Low pulse oximetry, Upper gastrointestinal endoscopy, WEI NASAL JET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Oxygen(2L/min) supplied with nasal catheter |
| Nasopharyngeal airway group | Experimental | Device: Nasopharyngeal airway without jet ventilatorOxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator |
| WEI NASAL JET group | Experimental | Device: WEI NASAL JETOxygen supplied through WEI NASAL JET with a manual jet ventilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing upper gastrointestinal endoscopy
- age over 18 years old
- Signed informed consent form
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WEI NASAL JETAlso: Nasopharyngeal airway embedded with jet ventilation catheterOxygen is supplied through WEI NASAL JET by a manual jet ventilator | Device | WEI NASAL JET group |
| Nasopharyngeal airway without jet ventilatorOxygen is supplied directly through WEI NASAL JET without jet ventilator | Device | Nasopharyngeal airway group |
Primary outcome
Low pulse oximetry incidence
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
1 secondary outcome
Other adverse events
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Derived from this study: PubMed 28974061Qin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diansan Su, Dr. study chair
Renji Hospital, School of Medicine, Shanghai Jiaotong University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WEI NASAL JET and Nasopharyngeal airway without jet ventilator in people with Peptic Ulcer and Gastric Cancer, run by RenJi Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Dr. (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low pulse oximetry incidence (time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02436018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.