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NCT Number: NCT06711328

Effect of New Oropharyngeal Airway on Incidence of Hypoxia During Painless Gastroenteroscopy in Elderly Patients

With the aging of Chinese population, the early screening of gastrointestinal diseases and the promotion and implementation of comfortable medical treatment, more and more elderly patients choose painless gastroenteroscopy for diagnosis and treatment.However, the incidence of anesthesia-related adverse reactions and complications is high in elderly patients.Hypoxemia caused by anesthetic-induced respiratory depression and airway obstruction is a serious complication in painless gastroenteroscopy.Severe hypoxemia not only requires emergency airway intervention, such as mask ventilation or even tracheal intubation, but also leads to the interruption of endoscopic diagnosis and treatment.Advanced age was an independent risk factor for hypoxemia during painless gastroenteroscopy,This study observed the effect of a new type of oropharyngeal ventilation in improving the elderly painless gastroenteroscopy anesthesia hypoxemia and reducing intraoperative airway intervention, so as to evaluate the safety and effectiveness of a new type of nasopharyngeal ventilation in the elderly painless gastrointestinal diagnosis and treatment, and provide clinical reference.

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The oropharyngeal airway is an important airway auxiliary device for short-term airway management during the perianesthetic period, which can provide patients with an unobstructed airway during autonomous ventilation .The oropharyngeal vent has been proven to be successfully used in infants, the elderly and MRI, and can be used in short outpatient surgery instead of laryngeal mask .The oropharyngeal airway has a low incidence of pharyngeal trauma and laryngeal pain immediately after surgery, requiring a shorter exposure time of inhaled anesthetic and a lower concentration of propofol to successfully place it .During the operation to preserve spontaneous breathing, the oropharyngeal airway is introduced as a ventilation device .The new oropharyngeal airway can accept the implantation of gastroscopy and provide oxygen to patients without affecting the operation at the same time. In order to explore whether the new oropharyngeal airway can provide better oxygen to patients undergoing painless gastroenteroscopy and reduce the incidence of hypoxia during the operation, we have drafted this study and explored the safety of the new oropharyngeal airway in painless gastroenteroscopy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65-80 years old
  • written informed consent of patient or family member
  • painless stomach + colonoscopy
  • ASA grade I-II

Exclusion criteria

  • Patients with clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who could not perform oropharyngeal airway ventilation;
  • 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 should not participate in this study.

Treatment and study plan

New oropharyngeal airway

Device

This product is produced and sold by Shanghai Elifu Medical Technology Co., LTD., and has been officially put into clinical use in March 2023.The product is named oropharyngeal airway for disposable endoscope, which is composed of nasal plug, bite, oropharyngeal channel, oxygen supply tube, lanyard and optional accessories carbon dioxide gas catheter and carbon dioxide collection tube.The model used in this study is JK (Oropharyngeal airway for endoscope with end-expiratory carbon dioxide Collection) with L/M/S three specifications, which is used to prevent airway obstruction caused by backward tongue fall during endoscopic surgery/examination, establish oropharyngeal airway for patients, and provide nasal oxygen at the same time

Primary outcomes

  1. The incidence of hypoxia

    Time frame: 1 minute after anesthesia induction

    The incidence of hypoxia (75% ≤ SpO2 < 90%, ≤ 60s)

Secondary outcomes

  1. The incidence of severe hypoxia

    Time frame: 1 minute after anesthesia induction

    The incidence of severe hypoxia (SpO2 < 75% or 75% ≤SpO2 < 90%, ≥60s)

  2. The incidence of requiring airway intervention

    Time frame: 1 minute after anesthesia induction

    Tracheal intubation and noninvasive ventilation are required

  3. Cyclic fluctuation

    Time frame: 1 minute after anesthesia induction

    Severe bradycardia (< 50 beats/min), MAP fluctuation greater than 30% of the baseline value or MAP < 60 mmHg

  4. The satisfaction of endoscopists was recorded

    Time frame: Within 30 minutes after anesthesia awakening

    Patient satisfaction scales usually use a 0-10 scale, where 0 is very dissatisfied and 10

  5. Recorded adverse events

    Time frame: 1 minute after anesthesia induction

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianbo Wu, Doctoral

CONTACT

[email protected]

18560083793

Qi You, Master

CONTACT

[email protected]

19553100910

Sponsors and collaborators

Lead sponsor

Jianbo Wu

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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