Choledocholithiasis With Cholecystitis With ObstructionNCT07637721
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
A study testing The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group and The Regular Nasal Cannula in people with Choledocholithiasis With Cholecystitis With Obstruction and Obstructive Jaundice, run by Zhejiang University at 3 sites in China.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used for the diagnosis and treatment of pancreatobiliary diseases. While Monitored Anesthesia Care (MAC) enhances the efficiency of ERCP, deep sedation introduces significant airway risks, particularly hypoxemia resulting from sedative-induced upper… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice, Pancreatitis
- What is being tested?
- The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group and The Regular Nasal Cannula
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 3 sitesChina
- Study dates
- 12 Nov 2026to 31 Dec 2027
- Phase
- Interventional
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
- Age≥18years
- The ASA classification ranges from I to III
- Patients have signed the informed consent form
- Patients scheduled to undergo sedated ERCP examination procedure
Who cannot join
- Severe cardiac dysfunction (<4 METs);
- Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
- Upper respiratory tract infections including oral, nasal or pharyngeal infections;
- Fever (core temperature >37.5°C);
- Confirmed pregnancy or current breastfeeding;
- Hypersensitivity to sedative drugs such as propofol;
- Current participation in other clinical trials;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Diansan Su, PhD, MD, +8618616514088 ext. +861861651408, diansansu@yahoo.com
Lianjuan Sun, Master, +8618257152767, sunlianjuan26@163.com
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, 310011
Tianjin Nankai Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, 300100
About this study
Official title: Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation：a Randomized Controlled Trial
Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used for the diagnosis and treatment of pancreatobiliary diseases. While Monitored Anesthesia Care (MAC) enhances the efficiency of ERCP, deep sedation introduces significant airway risks, particularly hypoxemia resulting from sedative-induced upper airway collapse. With reported hypoxemia rates ranging from 10% to 69%, and the potential for severe complications such as myocardial ischemia and neurological damage, effective airway management is paramount. Supraglottic oxygenation via oral transtracheal catheter provides a viable method for relieving obstruction and enabling positive pressure ventilation, serving as a less invasive alternative to tracheal intubation. Despite its proven utility in other settings, this technique has not yet been evaluated in the context of deeply sedated ERCP.
- Conditions
- Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice, Pancreatitis, Cholelithiasis
- Being tested
- The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group, The Regular Nasal Cannula
- Keywords
- ERCP, Monitored Anesthesia Care, deep sedation, hypoxemia, The Supraglottic Oxygenation Via Oral Transtracheal Catheter
- Medical subject headings
- Jaundice, Obstructive, Pancreatitis, Cholelithiasis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Supraglottic Oxygenation Via Oral Transtracheal Catheter GroupDevice
Patients received supraglottic oxygenation via an oral transtracheal catheter
The Regular Nasal CannulaDevice
Patients received oxygenation via the regular nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group | Experimental | In this group, patients received supraglottic oxygenation via an oral transtracheal catheter Receives: Device: The Supraglottic Oxygenation Via Oral Transtracheal Catheter Group |
| The Regular Nasal Cannula Group | Active comparator | In this group, patients received oxygenation via the regular nasal cannula Receives: Device: The Regular Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia
75%≤SpO2<90%for<60s
Measured: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)
Secondary outcomes (2)
The incidence of sub-clinical respiratory depression
90%</=SpO2<95%
Measured: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)
The incidence of severe hypoxia
SpO2<75%or75%≤SpO2< 90%for≥60s
Measured: Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start12 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choledocholithiasis With Cholecystitis With ObstructionStudies of the same condition, open and under way.
- 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
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637721
- Sponsor's protocol ID
- ZJU2025C221
- Status last verified
- Sep 2026
- First submitted
- 19 May 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided