ObesityNCT06590922
Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy
A study testing Group using new oropharyngeal airway (experimental group) in people with Obesity and Gastrointestinal Endoscopy, run by Qianfoshan Hospital.
Trial summary
Painless endoscopy is a popular method of endoscopic diagnosis and treatment. Propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has a significant respiratory center inhibition effect, resulting… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Gastrointestinal Endoscopy, Airway Management
- What is being tested?
- Group using new oropharyngeal airway (experimental group)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- 30≤BMI≤40
- Written informed consent of patient or family
- painless stomach + colonoscopy
- ASA grade I-II
Who cannot join
- Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation;
- Severe cardiac insufficiency (≤4mets);
- Patients with severe renal insufficiency;
- diagnosed severe hepatic insufficiency;
- Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy;
- Increased intracranial pressure;
Show all 18Show fewer
- Upper respiratory tract infections such as mouth, nose or throat;
- Fever (core body temperature ≥37.5℃);
- A confirmed diagnosis of pregnancy or breastfeeding;
- Allergic to sedatives such as propofol or equipment such as tape;
- Emergency surgery;
- Multiple trauma;
- SpO2 < 95% before operation;
- A history of drug and/or alcohol abuse within 2 years prior to the start of the screening period;(Drinking more than three times standard alcoholic beverages per day, equivalent to about 10g of alcohol or equivalent to 50g of Chinese liquor);
- Patients with previous psychiatric and neurological diseases, such as depression, severe central nervous depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis;
- Currently participating in other clinical trials;
- Patients who are deemed unfit by the investigator to participate in the trial;
- Patients with a history of smoking were excluded
Trial locations and contacts
No sites are listed yet.
About this study
Painless endoscopy is a popular method of endoscopic diagnosis and treatment. Propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has a significant respiratory center inhibition effect, resulting in a decrease in blood oxygen saturation of patients, especially obese patients, who are more likely to suffer from a sudden drop in blood oxygen and even threaten their lives .Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypopnea may occur during painless colonoscopy due to the influence of sedative and analgesic drugs, resulting in hypoxia in patients. In addition, the anatomical and pathological changes of obese patients themselves make hypoxia tolerance poor and airway establishment difficult, which may endanger the safety of patients .Currently, there is no special oropharyngeal ventilation device used during gastroenteroscopy. Recently, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the conventional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the air tightness inside the nose mask and maximize the oxygen supply efficiency. The carbon dioxide outlet connected to the oropharyngeal airway body can not only collect the patient's exhaled gas, but also reduce the backflow of carbon dioxide gas.It can also access carbon dioxide detection equipment to monitor the patient's PCO2 at the end of breath in real time .In order to evaluate whether the new oropharyngeal airway can reduce the incidence of hypoxia in ordinary patients during painless gastroenteroscopy, the investigators prepared this study and explored the safety and effectiveness of the new oropharyngeal airway .
Read the detailed description
- The study population was recruited by the investigator participating in the clinical trial under the control of the principal investigator. 226 obese patients (30≤BMI≤40) who had undergone painless gastroenteroscopy since the same day were selected and informed and consented to the clinical trial.2. Sample size calculation:According to the pre-test results of obese people, the incidence of hypoxia in the test group and the control group was 0.08 and 0.26, respectively. The sample size was calculated using PASS software, and the bilateral test level α=0.05 was set, and the test efficacy power=0.9 was set. According to the incidence of hypoxia, 90 cases were required in each group, and 113 cases in each group were calculated after considering 20% shedding rate.A total of 226 cases.3. Specific study contents: Study participants entered the examination room to establish venous access, and used 2% lidocaine gel 5ml containing mouthwash and pharynx.Heart rate (HR), pulse oxygen saturation (SpO2), end-expiratory carbon dioxide, ECG monitoring, and non-invasive blood pressure (measured every 2.5 minutes) were routinely monitored before anesthesia induction.Ask patient to lie on left side.In this study, the investigators participating in this clinical trial plan to implement simple randomization using SAS: (1) The group using the new oropharyngeal airway (trial group) : Oxygen is continuously supplied through a catheter partially attached to the endoscopic bite before induction of anesthesia until the end of gastroenteroscopy.(2) In the conventional endoscopic bite group (control group), oxygen was continuously supplied through a common nasal catheter before induction of anesthesia until the end of gastroenteroscopy.The entire trial operation process was completed by the investigators participating in the clinical study.Before induction of anesthesia, study participants in the experimental group received 5-6L/min of oxygen for about 1 minute through an endoscopic biting oxygen supply device, and participants in the control group inhaled 5-6L/min of oxygen for about 1 minute through a nasal catheter.Propofol 3mg/kg and sufentanil 7μg were used to induce anesthesia in both groups.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1 minute later. When participants achieved sufficient sedation (BIS40 left and 12 right), the new oropharyngeal airway group was placed into the oropharyngeal airway through the endoscopic bite and then gastroscopy was performed.The ordinary endoscopic bite group began to perform endoscopic operation after sufficient sedation was achieved.In both groups, 5mg/kg·h propofol was injected continuously to maintain anesthesia until the examination was completed.If participants showed frowning or slight body movement during diagnosis and treatment, 40 to 50mg of propofol was added intravenously.If HR < 50 times/intravenous injection of atropine 0.5mg;MAP < 60mmHg intravenous hydroxyamine 1mg;When SpO2 < 92%, artificial airway intervention such as jaw support, assisted breathing or mask was given.After the examination, study participants were not allowed to leave the examination room until they had a MOAA/S score of 3-4.If the sedation/anaesthesia Discharge rating scale scores more than 9 points, patients can be accompanied by relatives and friends.The incidence of hypoxia (75%≤SpO2 < 90%, ≤60s) and severe hypoxia (SpO2 < 75% or 75%≤SpO2 < 90%, ≥60s) during anesthesia were recorded.The incidence of choking, reflux aspiration and laryngeal spasm were recorded.The time of intervention was half or disappearance of end-expiratory carbon dioxide and/or disappearance of thoracic fluctuation and/or SpO2 < 95%, that is, opening the airway successively until SpO2≥95%, and recording the last means of opening the airway.The means of opening the airway of the two groups were the same, including: 1) adjusting the oxygen flow;2) Lift the lower jaw;3) Mask ventilation (pull out the gastroscope if necessary);4) Tracheal intubation or laryngeal mask for ventilator assisted ventilation.
- Conditions
- Obesity, Gastrointestinal Endoscopy, Airway Management
- Being tested
- Group using new oropharyngeal airway (experimental group), The conventional endoscopic biting group (control group)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group using new oropharyngeal airway (experimental group)Device
Before anesthesia induction, study participants in the experimental group received 5-6L/min oxygen for about 1min through an endoscopic bite oxygen supply device, and anesthesia induction was administered with propofol 3mg/kg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. When participants achieved sufficient sedation (about BIS40), they were placed into the oropharyngeal airway through the endoscopic bite and began gastroscopy.Anesthetic maintenance was administered with a continuous pump of 5mg/kg·h propofol until completion of the examination.
The conventional endoscopic biting group (control group)Device
Prior to induction of anesthesia, control study participants inhaled 5 to 6L/min of oxygen through a nasal catheter for approximately 1 minute.Anesthesia was induced by propofol 3mg/kg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. The endoscopic procedure began when the study participants reached sufficient sedation (about BIS40) and the ordinary endoscopic bite group reached sufficient sedation.Anesthetic maintenance was administered with a continuous pump of 5mg/kg·h propofol until completion of the examination.
| Study group | Role | What they receive |
|---|---|---|
| Using a new oropharyngeal airway set | Experimental | Prior to induction of anesthesia and until the end of the gastroenteroscopy, oxygen was continuously supplied through a catheter partially attached to the endoscopic bite. Receives: Device: Group using new oropharyngeal airway (experimental group) |
| The conventional endoscopic bite group | Active comparator | Oxygen was administered continuously through a common nasal catheter until the end of the gastroenteroscopy prior to induction of anesthesia Receives: Device: The conventional endoscopic biting group (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxia
To investigate the incidence of new oropharyngeal airway hypoxia (75%≤SpO2 < 90%, ≤60s) during anesthesia in patients undergoing painless gastroenteroscopy
Measured: 1 minute after anesthesia induction
Secondary outcomes (5)
The incidence of severe hypoxia
The incidence of severe hypoxia (SpO2 < 75% or 75% ≤SpO2 < 90%, ≥60s)
Measured: 1 minute after anesthesia induction
The incidence of requiring airway intervention
Serious adverse events such as tracheal intubation, non-invasive ventilation are required
Measured: 1 minute after anesthesia induction
The dosage of additional drugs was recorded during the operation
The dosage of additional drugs was recorded during the operation
Measured: 1 minute after anesthesia induction
The satisfaction of endoscopists was recorded
The doctor satisfaction rating scale also uses a 0-10 rating scale, where 0 represents very dissatisfied and 10 represents very satisfied. Endoscopes need to select a corresponding number on the scoring table based on their actual experience to indicate whether the patient is satisfied with the patient's cooperation and response to the operation process.
Measured: Within 30 minutes after anesthesia awakening
Recorded adverse events
The incidence of choking, laryngeal spasm and reflux aspiration were observed.Apnea or slow breathing episodes (defined as respiratory rate ≤6 beats/min);Bradycardia is defined as a heart rate ≤50 beats/min.Serious adverse events such as tracheal intubation, non-invasive ventilation, use of vasopressors, and hospitalization are required.
Measured: 1 minute after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianbo Wu, Qianfoshan Hospital
- Investigators
- Jianbo Wu, Principal investigator, Department director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590922
- Sponsor's protocol ID
- YXLL-KY-2024 (082)
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy
- ClinicalTrials.gov ID
- NCT06590922
- Acronym / sponsor ID
- YXLL-KY-2024 (082)
- Conditions
- Obesity, Gastrointestinal Endoscopy, Airway Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Painless endoscopy is a popular method of endoscopic diagnosis and treatment. Propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has a significant respiratory center inhibition effect, resulting in a decrease in blood oxygen saturation of patients, especially obese patients, who are more likely to suffer from a sudden drop in blood oxygen and even threaten their lives .Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypopnea may occur during painless colonoscopy due to the influence of sedative and analgesic drugs, resulting in hypoxia in patients. In addition, the anatomical and pathological changes of obese patients themselves make hypoxia tolerance poor and airway establishment difficult, which may endanger the safety of patients .Currently, there is no special oropharyngeal ventilation device used during gastroenteroscopy. Recently, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the conventional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the air tightness inside the nose mask and maximize the oxygen supply efficiency. The carbon dioxide outlet connected to the oropharyngeal airway body can not only collect the patient's exhaled gas, but also reduce the backflow of carbon dioxide gas.It can also access carbon dioxide detection equipment to monitor the patient's PCO2 at the end of breath in real time .In order to evaluate whether the new oropharyngeal airway can reduce the incidence of hypoxia in ordinary patients during painless gastroenteroscopy, the investigators prepared this study and explored the safety and effectiveness of the new oropharyngeal airway .
Detailed description
- The study population was recruited by the investigator participating in the clinical trial under the control of the principal investigator. 226 obese patients (30≤BMI≤40) who had undergone painless gastroenteroscopy since the same day were selected and informed and consented to the clinical trial.2. Sample size calculation:According to the pre-test results of obese people, the incidence of hypoxia in the test group and the control group was 0.08 and 0.26, respectively. The sample size was calculated using PASS software, and the bilateral test level α=0.05 was set, and the test efficacy power=0.9 was set. According to the incidence of hypoxia, 90 cases were required in each group, and 113 cases in each group were calculated after considering 20% shedding rate.A total of 226 cases.3. Specific study contents: Study participants entered the examination room to establish venous access, and used 2% lidocaine gel 5ml containing mouthwash and pharynx.Heart rate (HR), pulse oxygen saturation (SpO2), end-expiratory carbon dioxide, ECG monitoring, and non-invasive blood pressure (measured every 2.5 minutes) were routinely monitored before anesthesia induction.Ask patient to lie on left side.In this study, the investigators participating in this clinical trial plan to implement simple randomization using SAS: (1) The group using the new oropharyngeal airway (trial group) : Oxygen is continuously supplied through a catheter partially attached to the endoscopic bite before induction of anesthesia until the end of gastroenteroscopy.(2) In the conventional endoscopic bite group (control group), oxygen was continuously supplied through a common nasal catheter before induction of anesthesia until the end of gastroenteroscopy.The entire trial operation process was completed by the investigators participating in the clinical study.Before induction of anesthesia, study participants in the experimental group received 5-6L/min of oxygen for about 1 minute through an endoscopic biting oxygen supply device, and participants in the control group inhaled 5-6L/min of oxygen for about 1 minute through a nasal catheter.Propofol 3mg/kg and sufentanil 7μg were used to induce anesthesia in both groups.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1 minute later. When participants achieved sufficient sedation (BIS40 left and 12 right), the new oropharyngeal airway group was placed into the oropharyngeal airway through the endoscopic bite and then gastroscopy was performed.The ordinary endoscopic bite group began to perform endoscopic operation after sufficient sedation was achieved.In both groups, 5mg/kg·h propofol was injected continuously to maintain anesthesia until the examination was completed.If participants showed frowning or slight body movement during diagnosis and treatment, 40 to 50mg of propofol was added intravenously.If HR < 50 times/intravenous injection of atropine 0.5mg;MAP < 60mmHg intravenous hydroxyamine 1mg;When SpO2 < 92%, artificial airway intervention such as jaw support, assisted breathing or mask was given.After the examination, study participants were not allowed to leave the examination room until they had a MOAA/S score of 3-4.If the sedation/anaesthesia Discharge rating scale scores more than 9 points, patients can be accompanied by relatives and friends.The incidence of hypoxia (75%≤SpO2 < 90%, ≤60s) and severe hypoxia (SpO2 < 75% or 75%≤SpO2 < 90%, ≥60s) during anesthesia were recorded.The incidence of choking, reflux aspiration and laryngeal spasm were recorded.The time of intervention was half or disappearance of end-expiratory carbon dioxide and/or disappearance of thoracic fluctuation and/or SpO2 < 95%, that is, opening the airway successively until SpO2≥95%, and recording the last means of opening the airway.The means of opening the airway of the two groups were the same, including: 1) adjusting the oxygen flow;2) Lift the lower jaw;3) Mask ventilation (pull out the gastroscope if necessary);4) Tracheal intubation or laryngeal mask for ventilator assisted ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using a new oropharyngeal airway set | Experimental | Device: Group using new oropharyngeal airway (experimental group)Prior to induction of anesthesia and until the end of the gastroenteroscopy, oxygen was continuously supplied through a catheter partially attached to the endoscopic bite. |
| The conventional endoscopic bite group | Active comparator | Device: The conventional endoscopic biting group (control group)Oxygen was administered continuously through a common nasal catheter until the end of the gastroenteroscopy prior to induction of anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years
- 30≤BMI≤40
- Written informed consent of patient or family
- painless stomach + colonoscopy
- ASA grade I-II
Key exclusion criteria (18 listed)
- Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation;
- Severe cardiac insufficiency (≤4mets);
- Patients with severe renal insufficiency;
- diagnosed severe hepatic insufficiency;
- Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy;
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 |
|---|---|---|
| Group using new oropharyngeal airway (experimental group)Before anesthesia induction, study participants in the experimental group received 5-6L/min oxygen for about 1min through an endoscopic bite oxygen supply device, and anesthesia induction was administered with propofol 3mg/kg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. When participants achieved sufficient sedation (about BIS40), they were placed into the oropharyngeal airway through the endoscopic bite and began gastroscopy.Anesthetic maintenance was administered with a continuous pump of 5mg/kg·h propofol until completion of the examination. | Device | Using a new oropharyngeal airway set |
| The conventional endoscopic biting group (control group)Prior to induction of anesthesia, control study participants inhaled 5 to 6L/min of oxygen through a nasal catheter for approximately 1 minute.Anesthesia was induced by propofol 3mg/kg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. The endoscopic procedure began when the study participants reached sufficient sedation (about BIS40) and the ordinary endoscopic bite group reached sufficient sedation.Anesthetic maintenance was administered with a continuous pump of 5mg/kg·h propofol until completion of the examination. | Device | The conventional endoscopic bite group |
Primary outcome
Incidence of hypoxia
Time frame: 1 minute after anesthesia induction
To investigate the incidence of new oropharyngeal airway hypoxia (75%≤SpO2 < 90%, ≤60s) during anesthesia in patients undergoing painless gastroenteroscopy
5 secondary outcomes
The incidence of severe hypoxia
Time frame: 1 minute after anesthesia induction
The incidence of requiring airway intervention
Time frame: 1 minute after anesthesia induction
The dosage of additional drugs was recorded during the operation
Time frame: 1 minute after anesthesia induction
The satisfaction of endoscopists was recorded
Time frame: Within 30 minutes after anesthesia awakening
Recorded adverse events
Time frame: 1 minute after anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Jianbo Wu principal investigator
Department director
Questions about this trial
What is this clinical trial studying?
A study testing Group using new oropharyngeal airway (experimental group) in people with Obesity and Gastrointestinal Endoscopy, run by Qianfoshan Hospital.
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 5 inclusion and 18 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Jianbo Wu, Doctorate (18560083793, jianbowu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxia (time frame: 1 minute after anesthesia induction). 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 19 Sep 2024.