An interventional study of Routine nasal catheter group and Mask group in Hypoxemia, sponsored by Sichuan Provincial People's Hospital. Recruiting at 5 sites in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Sichuan Provincial People's Hospital · Not applicable, Interventional, and Treatment
To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy
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.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's planned enrollment of 1,208 is above the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Sichuan Provincial People's Hospital is the lead sponsor of 76 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter
Device: Mask 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
Device: Routine 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
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
Incidence of hypoxemia
Incidences of oxygen saturation falling below 92%
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Incidence of compromised ventilation mandating primary manual intervention
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).
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Incidence necessitating sophisticated manual ventilatory support during pain-free gastroscopy
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.
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Juxtaposition of hypoxemia onset time in both ventilation techniques
The time span from the start of drug administration by the researcher to the first occurrence of blood oxygen saturation below 92%.
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
the temporal span from initial decline to recovery to 92% saturation in both ventilation techniques
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
Time frame: 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 in both ventilation techniques
the lowest oxygen saturation from the start of medication administration to the participants's Aldrete score of 9.
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Evaluation of procedural prolongation due to ventilation issues
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
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Apnea prevalence in both groups
The study here we define apnea as 10 second without obvious respiratory movements of mesothorax and abdomen or snoring with paradoxical breathing
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Satisfaction scores1 from patients, endoscopists, and anesthesiologists
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.
Time frame: Immediately after the procedure.
Satisfaction scores2 from patients, endoscopists, and anesthesiologists
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.
Time frame: Immediately after the procedure.
The incidence of upper respiratory tract discomfort manifestations such as oral, nasal, an pharyngeal dryness and hemorrhage in two groups of participants.
Time frame: Immediately after the procedure.
Inaugural insertion success rates in two groups of participants
If the endoscopic operation fails to pass the pharynx after three attempts, recorded as the first insertion failure.
Time frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Plan to share: Yes — After December 2024, the original data can be obtained through the author's email address.
Supporting information: Study protocol, Sap, Icf, Csr
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Sichuan Provincial People's Hospital