Endoscopic UltrasonographyNCT04549623
End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography
A study testing Novel end-tidal CO2 monitoring device and SpO2 and respiratory motion monitoring in people with Endoscopic Ultrasonography and Sedation, run by Changhai Hospital at 1 site in China.
Trial summary
To meet the needs of both operators and patients, moderate and deep sedation has been widely used in digestive endoscopy, which is invasive and painful. With its pleasant effects, sedation has complications nevertheless. And respiratory depression is the most common one, which makes respiratory monitoring significant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Endoscopic Ultrasonography, Sedation, Monitoring
- What is being tested?
- Novel end-tidal CO2 monitoring device and SpO2 and respiratory motion monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2020to Feb 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for ultrasonography-guided fine needle aspiration
- Adult patients aged 18 to 65 years
- American Society of Anesthesiologists (ASA) Physical Status Classification I-III
- Subjects provide informed consent
Who cannot join
- Full stomach or upper gastrointestinal tract obstruction
- Baseline pulse oximetric saturation (SpO2) <95% while breathing room air
- Obesity （BMI≥28kg/m2）or anticipated difficult airway
- Cardiovascular or cerebrovascular events within 3 months
- Pregnancy
- Chronic opioid user
- Allergic to anesthetics
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Faculty of Anesthesiology, Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Jia-feng Wang, M.D., +86-21-31161853, jfwang@smmu.edu.cn
Jia-feng Wang, M.D.
About this study
Official title: The Effect of A Novel End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography-Guided Fine Needle Aspiration
To meet the needs of both operators and patients, moderate and deep sedation has been widely used in digestive endoscopy, which is invasive and painful. With its pleasant effects, sedation has complications nevertheless. And respiratory depression is the most common one, which makes respiratory monitoring significant. SpO2 and respiratory motion are regularly monitored without satisfying timeliness or sensitivity. Capnography with current device is only able to detect either oral or nasal breathing. The present study was designed to test the effect of the investigator's modified End-Tidal Carbon Dioxide (ETCO2) monitoring device for sedation during endoscopic ultrasonography-guided fine needle aspiration.
- Conditions
- Endoscopic Ultrasonography, Sedation, Monitoring
- Being tested
- Novel end-tidal CO2 monitoring device, SpO2 and respiratory motion monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel end-tidal CO2 monitoring deviceDevice
Apart from SpO2 and respiratory motion monitoring, the EtCO2 monitoring device is used to detect CO2 from nose and mouth simultaneously.
SpO2 and respiratory motion monitoringDevice
Finger SpO2 and ECG-based respiratory motion monitoring are used during operation.
| Study group | Role | What they receive |
|---|---|---|
| Group ETCO2 | Experimental | Novel end-tidal carbon dioxide monitoring device is used for sedation. Receives: Device: Novel end-tidal CO2 monitoring device |
| Group Reg | Experimental | Peripheral oxygen saturation (SpO2) and respiratory motion are regularly monitored during sedation. Receives: Device: SpO2 and respiratory motion monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral oxygen saturation
Peripheral oxygen saturation is measured by pulse oximetry and hypoxemia is defined as SpO2≤91%
Measured: Across the sedation, assessed up to 2 hours
Secondary outcomes (6)
Arterial pO2 and pCO2
The results of arterial blood gas measurements including partial pressure of oxygen (pO₂) and carbon dioxide (pCO₂)
Measured: 30 minutes after initiation of the sedation
The numbers of the times of body movement
The numbers of the times of any body movement across the procedure
Measured: From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours
Incidence of hypertension and hypotension
Hypertension or hypotension is defined as an increase or decrease in systolic blood pressure ≥20% compared to baseline values
Measured: From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours
Recovery time
Duration of the recovery from sedation
Measured: After termination of the sedation medication, assessed up to 2 hours
Total dosage of propofol
The patients are induced with 1.5~2.5mg/kg and maintained with 6~10mg/(kg•h) propofol. A propofol bolus dose range 0.2~0.5 mg/kg will be administered when needed.
Measured: Across the sedation, assessed up to 2 hours
Satisfaction score of the patients and endosonographers
Satisfaction score of the patients and endosonographers regarding to the sedation quality measured by a 0-100 visual analogue scale (VAS). 100 refers to the highest satisfaction degree while 0 refers to the worst satisfaction degree.
Measured: Across the procedure, assessed up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start27 Sep 2020
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic UltrasonographyStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-feng Wang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549623
- Sponsor's protocol ID
- ETCO2-MDS
- Status last verified
- Oct 2020
- First submitted
- 31 Aug 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of A Novel End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography-Guided Fine Needle Aspiration
- ClinicalTrials.gov ID
- NCT04549623
- Acronym / sponsor ID
- ETCO2-MDS
- Conditions
- Endoscopic Ultrasonography, Sedation, Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 16 Sep 2020 (actual)
- 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.
To meet the needs of both operators and patients, moderate and deep sedation has been widely used in digestive endoscopy, which is invasive and painful. With its pleasant effects, sedation has complications nevertheless. And respiratory depression is the most common one, which makes respiratory monitoring significant. SpO2 and respiratory motion are regularly monitored without satisfying timeliness or sensitivity. Capnography with current device is only able to detect either oral or nasal breathing. The present study was designed to test the effect of the investigator's modified End-Tidal Carbon Dioxide (ETCO2) monitoring device for sedation during endoscopic ultrasonography-guided fine needle aspiration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ETCO2 | Experimental | Device: Novel end-tidal CO2 monitoring deviceNovel end-tidal carbon dioxide monitoring device is used for sedation. |
| Group Reg | Experimental | Device: SpO2 and respiratory motion monitoringPeripheral oxygen saturation (SpO2) and respiratory motion are regularly monitored during sedation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for ultrasonography-guided fine needle aspiration
- Adult patients aged 18 to 65 years
- American Society of Anesthesiologists (ASA) Physical Status Classification I-III
- Subjects provide informed consent
Key exclusion criteria (7 listed)
- Full stomach or upper gastrointestinal tract obstruction
- Baseline pulse oximetric saturation (SpO2) <95% while breathing room air
- Obesity （BMI≥28kg/m2）or anticipated difficult airway
- Cardiovascular or cerebrovascular events within 3 months
- Pregnancy
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 |
|---|---|---|
| Novel end-tidal CO2 monitoring deviceApart from SpO2 and respiratory motion monitoring, the EtCO2 monitoring device is used to detect CO2 from nose and mouth simultaneously. | Device | Group ETCO2 |
| SpO2 and respiratory motion monitoringFinger SpO2 and ECG-based respiratory motion monitoring are used during operation. | Device | Group Reg |
Primary outcome
Peripheral oxygen saturation
Time frame: Across the sedation, assessed up to 2 hours
Peripheral oxygen saturation is measured by pulse oximetry and hypoxemia is defined as SpO2≤91%
6 secondary outcomes
Arterial pO2 and pCO2
Time frame: 30 minutes after initiation of the sedation
The numbers of the times of body movement
Time frame: From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours
Incidence of hypertension and hypotension
Time frame: From the completion of sedation to the completion of endosonography procedure, assessed up to 2 hours
Recovery time
Time frame: After termination of the sedation medication, assessed up to 2 hours
Total dosage of propofol
Time frame: Across the sedation, assessed up to 2 hours
Satisfaction score of the patients and endosonographers
Time frame: Across the procedure, assessed up to 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Endoscopic Ultrasonography
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Active, not recruiting
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Lung Cancer, Lung; Node
Not yet recruitingObservational study
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Pancreatic Mucinous Cystic Neoplasm, Pancreatic Serous Cystic Neoplasm
RecruitingObservational study
An Artificial Intelligence System for Multimodal, Multi-class Diagnosis of Pancreatic Cystic Lesions Based on Endoscopic Ultrasonography
Pancreatic Cystic Lesion (PCL)
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel end-tidal CO2 monitoring device and SpO2 and respiratory motion monitoring in people with Endoscopic Ultrasonography and Sedation, run by Changhai Hospital at 1 site 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 4 inclusion and 7 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jia-feng Wang, MD (+862131161869, jfwang@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral oxygen saturation (time frame: Across the sedation, assessed up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2020.