Airway Management Clinical Trial
Official title:
Randomized Controlled Clinical Study of the Incidence of Hypoxia in a Novel Oropharyngeal Airway During Painless Gastroenteroscopy
Verified date | March 2024 |
Source | Qianfoshan Hospital |
Contact | Jianbo Wu |
Phone | jianbowu@126.com |
312011097[@]qq.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 228 |
Est. completion date | March 3, 2025 |
Est. primary completion date | October 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | Inclusion Criteria:Voluntary acceptance;Asa1-2 level;Age 18-95y;Mallampati grades ? or ? Exclusion Criteria: 1. 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; 2. Severe cardiac insufficiency (<4mets); 3. Patients with severe renal insufficiency (requiring dialysis before surgery); 4. Diagnosed severe liver insufficiency; 5. Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy; 6. Increased intracranial pressure; 7. Upper respiratory tract infections such as mouth, nose or throat; 8. Fever (core body temperature >37.5 degrees Celsius); 9. a confirmed diagnosis of pregnancy or breastfeeding; 10. Allergic to sedatives such as propofol or equipment such as tape; 11. Emergency surgery; 12. Multiple trauma; 13. SpO2 < 95% in preoperative breathing air; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Qianfoshan Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | during surgery | |
Secondary | The incidence of choking, reflux aspiration and laryngeal spasm were recorded | The incidence of choking, reflux aspiration and laryngeal spasm were recorded | during surgery | |
Secondary | The dose of additional drugs during the operation | The total amount of propofol administered throughout the test was recorded | during surgery | |
Secondary | Endoscopist satisfaction | The endoscopist was asked to score the satisfaction after the operation | within 30 minutes after surgery | |
Secondary | 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. | during surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03908411 -
The Effect of Paratracheal Pressure on the Glottic View
|
N/A | |
Completed |
NCT04564105 -
Simulation Training and Teamwork Concerning Intubation on the Icu
|
N/A | |
Completed |
NCT02988336 -
TMHT - New Method of Difficult Intubation Prediction
|
N/A | |
Completed |
NCT03002857 -
Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery
|
N/A | |
Recruiting |
NCT06337006 -
Laryngeal Mask Airway Failure in Pediatric Patients
|
||
Completed |
NCT03443219 -
RCT- LMA Supremeā¢ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients
|
N/A | |
Completed |
NCT05044416 -
VieScope in Patients With an Expected Difficult Airway
|
N/A | |
Not yet recruiting |
NCT05534451 -
Comparison Among Three Different Video Scope Guided Nasotracheal Intubation.
|
N/A | |
Recruiting |
NCT06073977 -
Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
|
||
Not yet recruiting |
NCT03687385 -
The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients
|
N/A | |
Not yet recruiting |
NCT03687424 -
Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults?
|
N/A | |
Enrolling by invitation |
NCT05055401 -
Airway Management Skills Amongst Anesthesia Providers
|
||
Not yet recruiting |
NCT02920879 -
Airway Effects of PEEP During Anesthesia Induction.
|
N/A | |
Terminated |
NCT02644837 -
AuraGain and iGel Crossover Comparison
|
N/A | |
Completed |
NCT02263300 -
Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
|
||
Completed |
NCT01718561 -
The Difficult Airway Management Trial: "The DIFFICAIR-Trial"
|
N/A | |
Completed |
NCT01635660 -
Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation
|
N/A | |
Completed |
NCT00956592 -
Clinical Evaluation of the Storz CMAC Laryngoscope
|
N/A | |
Completed |
NCT00892671 -
Airway Management and Vascular Access Simulation
|
N/A | |
Completed |
NCT03848559 -
Airway Management With Simulated Microgravity Using a Submerged Model
|
N/A |