Airway ManagementNCT06304337
Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy
A study testing New oropharyngeal airway group in people with Airway Management, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2<90%, t>10s) and severe hypoxia (Spo2<85%) during… Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- New oropharyngeal airway group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 3 Mar 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
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 (requiring dialysis before surgery);
- Diagnosed severe liver 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 13Show fewer
- Upper respiratory tract infections such as mouth, nose or throat;
- Fever (core body temperature >37.5 degrees Celsius);
- a confirmed diagnosis of pregnancy or breastfeeding;
- Allergic to sedatives such as propofol or equipment such as tape;
- Emergency surgery;
- Multiple trauma;
- SpO2 < 95% in preoperative breathing air;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University（Qianfoshan Hospital, Shandong Province）
Jinan
Qi You, 19553100910, 312011097@qq.com
About this study
Official title: Randomized Controlled Clinical Study of the Incidence of Hypoxia in a Novel Oropharyngeal Airway During Painless Gastroenteroscopy
The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2<90%, t>10s) and severe hypoxia (Spo2<85%) during anesthesia and sedation, as well as the incidence of cough and laryngeal spasm, as well as the dose, endoscopist satisfaction, and the incidence of various adverse events were observed.To accumulate clinical experience and reference of anesthesia in obese patients.
Read the detailed description
Painless endoscopy is a popular method of endoscopic diagnosis and treatment.General intravenous anesthesia with propofol and fentanyl has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has an obvious respiratory central inhibitory effect, resulting in a decrease in blood oxygen saturation in patients, especially in obese and elderly patients, who are more prone to a sudden decrease in blood oxygen, and even life-threatening.Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypopnea may occur during painless colonoscopy due to sedative and analgesic drugs.Causing the patient to be starved of oxygen.At present, there is no special oropharyngeal ventilation device for gastroenteroscopy.In recent years, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the traditional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the internal air tightness of the nose mask, and maximize the oxygen supply efficiency.Connecting the carbon dioxide outlet of the oral pharyngeal airway body can not only collect the exhaled gas of the patient, but also reduce the backflow of carbon dioxide gas.It can also be connected to a carbon dioxide detection device to monitor the partial pressure of carbon dioxide at the end of a patient's breath in real time.To evaluate whether a new type of oropharyngeal airway can reduce the incidence of hypoxia during painless gastroenteroscopy in general patients, the investigators present this study and investigate the safety and efficacy of the new type of oropharyngeal airway.
- Conditions
- Airway Management
- Being tested
- New oropharyngeal airway group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New oropharyngeal airway groupDevice
Oropharyngeal airwayIt is composed of nasal plug, bite mouth, oropharyngeal passage, oxygen supply tube, rope and optional accessories carbon dioxide gas catheter and carbon dioxide collection tube.For patients undergoing endoscopic surgery/examination to prevent airway obstruction caused by backtongue fall, establish oropharyngeal airway for patients, and provide nasal oxygen at the same time, JK model can monitor oropharyngeal end-expiratory carbon dioxide collection.
| Study group | Role | What they receive |
|---|---|---|
| Ordinary oral cushion set | No intervention | Before anesthesia induction, patients in the experimental group received 5-6L/min of oxygen for about 1min through the endoscopic bite connecting oxygen supply device, and patients in the control group inhaled 5-6L/min of oxygen for about 1min through the nasal catheter.Both groups were anesthetised with propofol 3mg/Kg and sufentanil 7ug.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. After the subjects achieved sufficient sedation (about BIS40), The ordinary endoscopic bite group began to perform endoscopic operation after sufficient sedation was achieved,In both groups, 5mg/Kg/h propofol was continuously pumped to maintain anesthesia until completion of the examination. |
| New oropharyngeal airway group | Experimental | Before anesthesia induction, patients in the experimental group received 5-6L/min of oxygen for about 1min through the endoscopic bite connecting oxygen supply device, and patients in the control group inhaled 5-6L/min of oxygen for about 1min through the nasal catheter.Both groups were anesthetised with propofol 3mg/Kg and sufentanil 7ug.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. After the subjects achieved sufficient sedation (about BIS40), the new oropharyngeal airway group was placed into the oropharyngeal airway through the endoscopic bite and then began gastroscopy,In both groups, 5mg/Kg/h propofol was continuously pumped to maintain anesthesia until completion of the examination Receives: Device: New oropharyngeal airway group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxia (Spo2<90%,t>10s) and severe hypoxia (Spo2<85%) during anesthetic sedation
The incidence of hypoxia (75%≤SpO2 < 90%, < 60s) and severe hypoxia (SpO2 < 75% or 75%≤SpO2 < 90%, ≥60s) during anesthesia was 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, open airway manipulation was taken successively until SpO2≥95%, and the last means of opening the airway was recorded.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.
Measured: during surgery
Secondary outcomes (4)
The incidence of choking, reflux aspiration and laryngeal spasm were recorded
The incidence of choking, reflux aspiration and laryngeal spasm were recorded
Measured: during surgery
The dose of additional drugs during the operation
The total amount of propofol administered throughout the test was recorded
Measured: during surgery
Endoscopist satisfaction
The endoscopist was asked to score the satisfaction after the operation
Measured: within 30 minutes after surgery
Record adverse events that occur throughout the process
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: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024
- Primary completion10 Oct 2024 (estimated)
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianbo Wu, Study director, Department director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304337
- Sponsor's protocol ID
- YXLL-KY-2023(162)
- Status last verified
- Aug 2024
- First submitted
- 29 Jan 2024
- Last updated
- 27 Aug 2024
- Results posted
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study of the Incidence of Hypoxia in a Novel Oropharyngeal Airway During Painless Gastroenteroscopy
- ClinicalTrials.gov ID
- NCT06304337
- Acronym / sponsor ID
- YXLL-KY-2023(162)
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 12 Mar 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.
The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2<90%, t>10s) and severe hypoxia (Spo2<85%) during anesthesia and sedation, as well as the incidence of cough and laryngeal spasm, as well as the dose, endoscopist satisfaction, and the incidence of various adverse events were observed.To accumulate clinical experience and reference of anesthesia in obese patients.
Detailed description
Painless endoscopy is a popular method of endoscopic diagnosis and treatment.General intravenous anesthesia with propofol and fentanyl has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has an obvious respiratory central inhibitory effect, resulting in a decrease in blood oxygen saturation in patients, especially in obese and elderly patients, who are more prone to a sudden decrease in blood oxygen, and even life-threatening.Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypopnea may occur during painless colonoscopy due to sedative and analgesic drugs.Causing the patient to be starved of oxygen.At present, there is no special oropharyngeal ventilation device for gastroenteroscopy.In recent years, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the traditional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the internal air tightness of the nose mask, and maximize the oxygen supply efficiency.Connecting the carbon dioxide outlet of the oral pharyngeal airway body can not only collect the exhaled gas of the patient, but also reduce the backflow of carbon dioxide gas.It can also be connected to a carbon dioxide detection device to monitor the partial pressure of carbon dioxide at the end of a patient's breath in real time.To evaluate whether a new type of oropharyngeal airway can reduce the incidence of hypoxia during painless gastroenteroscopy in general patients, the investigators present this study and investigate the safety and efficacy of the new type of oropharyngeal airway.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ordinary oral cushion set | No intervention | –Before anesthesia induction, patients in the experimental group received 5-6L/min of oxygen for about 1min through the endoscopic bite connecting oxygen supply device, and patients in the control group inhaled 5-6L/min of oxygen for about 1min through the nasal catheter.Both groups were anesthetised with propofol 3mg/Kg and sufentanil 7ug.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. After the subjects achieved sufficient sedation (about BIS40), The ordinary endoscopic bite group began to perform endoscopic operation after sufficient sedation was achieved,In both groups, 5mg/Kg/h propofol was continuously pumped to maintain anesthesia until completion of the examination. |
| New oropharyngeal airway group | Experimental | Device: New oropharyngeal airway groupBefore anesthesia induction, patients in the experimental group received 5-6L/min of oxygen for about 1min through the endoscopic bite connecting oxygen supply device, and patients in the control group inhaled 5-6L/min of oxygen for about 1min through the nasal catheter.Both groups were anesthetised with propofol 3mg/Kg and sufentanil 7ug.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. After the subjects achieved sufficient sedation (about BIS40), the new oropharyngeal airway group was placed into the oropharyngeal airway through the endoscopic bite and then began gastroscopy,In both groups, 5mg/Kg/h propofol was continuously pumped to maintain anesthesia until completion of the examination |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 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 (requiring dialysis before surgery);
- Diagnosed severe liver 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 |
|---|---|---|
| New oropharyngeal airway groupOropharyngeal airwayIt is composed of nasal plug, bite mouth, oropharyngeal passage, oxygen supply tube, rope and optional accessories carbon dioxide gas catheter and carbon dioxide collection tube.For patients undergoing endoscopic surgery/examination to prevent airway obstruction caused by backtongue fall, establish oropharyngeal airway for patients, and provide nasal oxygen at the same time, JK model can monitor oropharyngeal end-expiratory carbon dioxide collection. | Device | New oropharyngeal airway group |
Primary outcome
Incidence of hypoxia (Spo2<90%,t>10s) and severe hypoxia (Spo2<85%) during anesthetic sedation
Time frame: during surgery
The incidence of hypoxia (75%≤SpO2 < 90%, < 60s) and severe hypoxia (SpO2 < 75% or 75%≤SpO2 < 90%, ≥60s) during anesthesia was 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, open airway manipulation was taken successively until SpO2≥95%, and the last means of opening the airway was recorded.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.
4 secondary outcomes
The incidence of choking, reflux aspiration and laryngeal spasm were recorded
Time frame: during surgery
The dose of additional drugs during the operation
Time frame: during surgery
Endoscopist satisfaction
Time frame: within 30 minutes after surgery
Record adverse events that occur throughout the process
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 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 study director
Department director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New oropharyngeal airway group in people with Airway Management, run by Qianfoshan 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 0 inclusion and 13 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 27 Aug 2024. 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 Jianbo Wu (jianbowu@126.com, 312011097@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxia (Spo2<90%,t>10s) and severe hypoxia (Spo2<85%) during anesthetic sedation (time frame: during surgery). 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 27 Aug 2024.