Nasopharyngeal Airway in Obese Patients Undergoing Painless Gastroenteroscopy Compared With Transnasopharyngeal Airway

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05835661
Collaborator
(none)
246
1
6
40.9

Study Details

Study Description

Brief Summary

Painless endoscopy is a popular endoscopic diagnosis and treatment method at present, and propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has an obvious respiratory center inhibition effect, leading to the decrease of blood oxygen saturation in patients, especially obese patients, more prone to blood oxygen plunge, even threatening life.Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypoventilation may occur during painless colonoscopy due to the influence of sedative and analgesic drugs, thus causing hypoxia in patients. In addition, the anatomical and pathological changes of obese patients themselves make hypoxia tolerance poor and airway establishment difficult, which may endanger the safety of patients.Currently, supracloglottic ventilation devices that have little impact on patients and are easy to accept are often used clinically to complete short daytime operations. The most common is the application of oropharyngeal ventilation to solve upper airway obstruction , however, oropharyngeal ventilation is inconvenient to use in gastroenteroscopy and treatment, while nasopharyngeal ventilation is suitable. However, based on the experience of observers,Although the nasopharyngeal airway can play a good role in the unobtrusived airway, the incidence of nasopharyngeal hemorrhage is high, and the comfort of patients is poor. Therefore, the researchers considered to directly insert the nasopharyngeal airway into the pharyngeal cavity next to the oral pad through the mouth, so as to achieve the effect of unobtrusived airway and increase the local oxygen concentration, and the idea of this experiment came from this.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this trial is to reduce complications, ensure safety during gastroenteroscopy and improve postoperative satisfaction of patients.According to the preliminary experimental results, the nasopharyngeal airway inserted by the oral pad is more convenient than the traditional operation, and the incidence of postoperative bleeding and pharyngeal pain is lower.The pros and cons of these two methods will be fully informed when the informed consent is signed with the patients at the early stage of the trial, so that the patients can voluntarily choose the implantation method.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    246 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Nasopharyngeal Airway in Obese Patients Undergoing Painless Gastroenteroscopy Compared With Transnasopharyngeal Airway
    Actual Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Observation on the application of nasopharyngeal airway

    Patients eligible for inclusion were selected, and after fully explaining the advantages and disadvantages of the two ways of nasopharyngeal airway, the patients were allowed to choose to be enrolled by themselves, and then subsequent observation was started

    Outcome Measures

    Primary Outcome Measures

    1. Operating duration [Intraoperative (From the insertion of nasopharyngeal airway to the adjustment of position under gastroscopy)]

      The period of time from the beginning of insertion of the nasopharyngeal airway until it is adjusted into place

    2. The incidence of nasopharyngeal hemorrhage and postoperative pharyngeal pain [The whole experiment process was completed from the beginning of anesthesia induction to Forty eight hours after surgery]

      The satisfaction survey was carried out in the resuscitation room after the recovery of the patients, and the adverse reactions such as bleeding and sore throat were asked

    Secondary Outcome Measures

    1. The lowest drop in SPO2 during anesthesia [Intraoperative (From the beginning to the end of anesthesia)]

      The lowest value of SPO2 drop during the whole operation

    2. Postoperative satisfaction of patients [The whole experiment process was completed from the beginning of anesthesia induction to Forty eight hours after surgery]

      The Minnesota satisfaction score was used for patient satisfaction. The short scale included three subscales of intrinsic satisfaction, extrinsic satisfaction and general satisfaction. The main items included: the 5-point scale was used, where 1= very dissatisfied with this aspect of my job, 2= dissatisfied with this aspect of my job;3= Not sure whether I am satisfied or dissatisfied with this aspect of my job;4= satisfied with this aspect of my job;5= Very satisfied with this aspect of my job.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria ASA1-2; BMI≥28; Age 18-65years old

    Exclusion Criteria

    Pregnancy; History of allergies to propofol; history of alcohol abuse; psychiatric or neurological disorders; speech and communication disorders; auditory or visual impairments that may affect quality assessment of recovery; prior memory or cognitive impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 YOU Qi Jinan China

    Sponsors and Collaborators

    • Qianfoshan Hospital

    Investigators

    • Principal Investigator: ChuanYu Sun, master, Department director

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qianfoshan Hospital
    ClinicalTrials.gov Identifier:
    NCT05835661
    Other Study ID Numbers:
    • YXLL-KY-2023(001)
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 28, 2023