Hypoxemia
Conditions
Keywords
hypoxemia, sedation, gastrointestinal sedation procedure, non-invasive ventilation, endoscopy mask
Brief summary
To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy
Detailed description
This study aims to utilize a large sample, multicenter, prospective clinical trial using a new mask oxygen supply technology. If the study confirms that the new mask can improve the airway safety and effectiveness in patient examinations, while improving examination efficiency and reducing failure rates, it will provide safety assurance for the early diagnosis and treatment of upper gastrointestinal diseases in high-risk populations.
Interventions
DEVICERoutine nasal catheter group
The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter as described in the guide
DEVICEMask group
The study team applied the mask with a head strap to ensure a proper seal,simultaneously ensuring the same oxygen flow rate as the control group
Sponsors
Anhui Sanhong Medical Device Technology Co., Ltd
Sichuan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomly assign participants to the standard nasal catheter oxygenation group and the endoscopy mask oxygen inhalation group
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 18 years; 2. Upcoming upper gastrointestinal sedation procedure; 3. Classification under the American Association of Anesthesiologists (ASA) status I-III; 4. Baseline oxygen saturation (SpO2) ≥95% in ambient air conditions.
Exclusion criteria
1. Individuals with previously documented difficulties in mask ventilation (DMV); 2. Patients predisposed to aspiration risks or episodes of vomiting; 3. Facial or jaw injuries or congenital abnormalities that render conventional face mask application infeasible; 4. An inability or unwillingness to utilize the novel disposable anesthesia face mask.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxemia | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | Incidences of oxygen saturation falling below 92% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence necessitating sophisticated manual ventilatory support during pain-free gastroscopy | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | If SpO2 levels further descended to ≤70% or persistently hovered below 85% for a duration exceeding 60 seconds, it mandated an immediate cessation of the ongoing procedure. The endoscope would be retracted, followed by the insertion of a standard oropharyngeal mask for assisted ventilation. In dire circumstances, the anesthesiologist might opt for advanced airway interventions, such as laryngeal mask application or endotracheal intubation. |
| Juxtaposition of hypoxemia onset time in both ventilation techniques | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | The time span from the start of drug administration by the researcher to the first occurrence of blood oxygen saturation below 92%. |
| the temporal span from initial decline to recovery to 92% saturation in both ventilation techniques | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | The time span from oxygen saturation below 92% to recovery to 92% after manual ventilatory support. If multiple episodes of hypoxia occur, all times will be added up |
| the lowest oxygen saturation in both ventilation techniques | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | the lowest oxygen saturation from the start of medication administration to the participants's Aldrete score of 9. |
| Evaluation of procedural prolongation due to ventilation issues | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | The extension time for examination is defined as the total time from stopping the operation and exiting the endoscope until the endoscope re-enters the digestive tract, to the same anatomical position before stopping the operation, If multiple episodes of withdrawal of endoscopy occur, all times will be added up |
| Incidence of compromised ventilation mandating primary manual intervention | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | For the nasal catheter cohort, this entailed jaw elevation and deploying a standard mask to augment the oxygen concentration inhaled. Concurrently, for the mask cohort, primary intervention involved mandible lifting and secure fastening of the mask sleeve for inflation (while ensuring the operational aperture remains sealed). |
| Satisfaction scores1 from patients, endoscopists, and anesthesiologists | Immediately after the procedure. | The scores of satisfaction 1：Are you satisfied with this endoscopic diagnosis and treatment,a score of 0 represents very dissatisfied, while a score of 10 represents very satisfied. |
| Satisfaction scores2 from patients, endoscopists, and anesthesiologists | Immediately after the procedure. | The scores of satisfaction2：If there is a chance, are you willing to use this non-invasive oxygen device again,a score of 0 indicates a strong unwillingness, while a score of 10 indicates a strong willingness. |
| The incidence of upper respiratory tract discomfort manifestations such as oral, nasal, an pharyngeal dryness and hemorrhage in two groups of participants. | Immediately after the procedure. | — |
| Inaugural insertion success rates in two groups of participants | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | If the endoscopic operation fails to pass the pharynx after three attempts, recorded as the first insertion failure. |
| Apnea prevalence in both groups | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | The study here we define apnea as 10 second without obvious respiratory movements of mesothorax and abdomen or snoring with paradoxical breathing |
Countries
China
Outcome results
None listed