Respiratory DepressionNCT03775122
TAES Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure
A study testing TAES in people with Respiratory Depression, run by RenJi Hospital at 1 site in China.
Trial summary
To explore the effectiveness of transcutaneous acupuncture electrical stimulation (TAES), a non-invasive modality in improvement of the function of respiration and circulation on elder patient during colonoscopy. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Depression
- What is being tested?
- TAES
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2019to 30 Apr 2019
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- patients aged 65 or older
- American Society of Anesthesiologists (ASA) grade I~II
- consent and voluntary participation in this experiment
- patients under colonoscopy
- none allergic to propofol and fentanyl
- airway assessment for none difficult airway
Who cannot join
- Allergic to propofol, fentanyl.
- ASA is greater than or equal to grade 3
- Abnormal respiratory tract may cause severe respiratory obstruction
- unsatisfactory control of hypertension, systolic pressure over 160 millimeter of mercury (mmHg) or diastolic pressure over 100 mmHg
- Hypotension, systolic pressure below 90 mmHg, heart rate (HR) <50bpm or >100bpm
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Diansan Su
Shanghai, Shanghai Municipality, 200127
diansan su, Dr., +862168383702, diansansu@yahoo.com
About this study
Official title: Transcutaneous Acupoint Electrical Stimulation Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure：A Randomized-controlled Trial
To explore the effectiveness of transcutaneous acupuncture electrical stimulation (TAES), a non-invasive modality in improvement of the function of respiration and circulation on elder patient during colonoscopy.
Read the detailed description
To assess the function of respiratory and circulation before precondition, during colonoscopy and end of the procedure, blood cortisol and catecholamine levels were measured also.The incidence of airway support, application of vasoactive drug or atropine during procedure were recorded in the meantime.
- Conditions
- Respiratory Depression
- Being tested
- TAES
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAESDevice
TAES over acupuncture point neiguan (pericardium 6) for 20min, placebo group only stick the stimulate electrode but no frequency and intensity
| Study group | Role | What they receive |
|---|---|---|
| Group 1 sedation group | Placebo comparator | Elderly patients under colonoscopy with sedation, but no real TAES neiguan(pc6)
sedation is using the typical protocol for the following: Slowly peripheral intravenous injection(0.5ml/s) of fentanyl 50μg, then followed with 1.5-2.5mg/kg propofol until loss of eyelash reflex, the Observer's Assessment of Alertness/Sedation Scale (OAAS) score Level3-5. Receives: Device: TAES |
| Group 2 sedation+TAES group | Experimental | Elderly patients under colonoscopy both have TAES neiguan(pc6) and sedation.
sedation is begun followed TAES. sedation is same as group2 do. TAES is same as group3 do. Receives: Device: TAES |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of oxygen saturation
The percentage of oxygen saturation between the sedation alone and sedation+TAES have at least 2 difference
Measured: from 20min before lay down to 24hours after performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start15 Feb 2019 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (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 Respiratory DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Weifeng, Dr, Study director, Renji Hospital,School of Medicine,Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775122
- Sponsor's protocol ID
- renji-2018-074
- Status last verified
- Feb 2019
- First submitted
- 10 Dec 2018
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Gong Y, Huai X, Gu X, Su D, Yu W, Xie H. Effects of transcutaneous electrical acupuncture point stimulation on peripheral capillary oxygen saturation in elderly patients undergoing colonoscopy with sedation: a prospective randomized controlled trial. Acupunct Med. 2021 Aug;39(4):292-298. doi: 10.1177/0964528420960479. Epub 2020 Nov 30.
PubMed 33256456
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Acupoint Electrical Stimulation Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure：A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT03775122
- Acronym / sponsor ID
- renji-2018-074
- Conditions
- Respiratory Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 13 Dec 2018 (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 explore the effectiveness of transcutaneous acupuncture electrical stimulation (TAES), a non-invasive modality in improvement of the function of respiration and circulation on elder patient during colonoscopy.
Detailed description
To assess the function of respiratory and circulation before precondition, during colonoscopy and end of the procedure, blood cortisol and catecholamine levels were measured also.The incidence of airway support, application of vasoactive drug or atropine during procedure were recorded in the meantime.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 sedation group | Placebo comparator | Device: TAESElderly patients under colonoscopy with sedation, but no real TAES neiguan(pc6) sedation is using the typical protocol for the following: Slowly peripheral intravenous injection(0.5ml/s) of fentanyl 50μg, then followed with 1.5-2.5mg/kg propofol until loss of eyelash reflex, the Observer's Assessment of Alertness/Sedation Scale (OAAS) score Level3-5. |
| Group 2 sedation+TAES group | Experimental | Device: TAESElderly patients under colonoscopy both have TAES neiguan(pc6) and sedation. sedation is begun followed TAES. sedation is same as group2 do. TAES is same as group3 do. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- patients aged 65 or older
- American Society of Anesthesiologists (ASA) grade I~II
- consent and voluntary participation in this experiment
- patients under colonoscopy
- none allergic to propofol and fentanyl
Key exclusion criteria (5 listed)
- Allergic to propofol, fentanyl.
- ASA is greater than or equal to grade 3
- Abnormal respiratory tract may cause severe respiratory obstruction
- unsatisfactory control of hypertension, systolic pressure over 160 millimeter of mercury (mmHg) or diastolic pressure over 100 mmHg
- Hypotension, systolic pressure below 90 mmHg, heart rate (HR) <50bpm or >100bpm
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 |
|---|---|---|
| TAESTAES over acupuncture point neiguan (pericardium 6) for 20min, placebo group only stick the stimulate electrode but no frequency and intensity | Device | Group 1 sedation group, Group 2 sedation+TAES group |
Primary outcome
The percentage of oxygen saturation
Time frame: from 20min before lay down to 24hours after performance
The percentage of oxygen saturation between the sedation alone and sedation+TAES have at least 2 difference
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Derived from this study: PubMed 33256456Chen Y, Gong Y, Huai X, Gu X, Su D, Yu W, Xie H. Effects of transcutaneous electrical acupuncture point stimulation on peripheral capillary oxygen saturation in elderly patients undergoing colonoscopy with sedation: a prospective randomized controlled trial. Acupunct Med. 2021 Aug;39(4):292-298. doi: 10.1177/0964528420960479. Epub 2020 Nov 30.
- Individual participant dataSharing planned: No
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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.
Yu Weifeng, Dr study director
Renji Hospital,School of Medicine,Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAES in people with Respiratory Depression, run by RenJi 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 6 inclusion and 5 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 18 Feb 2019. 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. Some participants in this study may receive a placebo. 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 chen yongming (13564932181, drchelman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of oxygen saturation (time frame: from 20min before lay down to 24hours after performance). 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 NCT03775122, 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 18 Feb 2019.