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

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835661
• Other study ID #: YXLL-KY-2023(001)
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: October 2023

Study information

• Verified date: April 2023
• Source: Qianfoshan Hospital
• Contact: You Qi, master
• Phone: 19553100910
• Email: 312011097[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: October 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication
• Patient Satisfaction

Locations

Country	Name	City	State
China	YOU Qi	Jinan

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating duration	The period of time from the beginning of insertion of the nasopharyngeal airway until it is adjusted into place	Intraoperative (From the insertion of nasopharyngeal airway to the adjustment of position under gastroscopy)
Primary	The incidence of nasopharyngeal hemorrhage and postoperative pharyngeal pain	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	The whole experiment process was completed from the beginning of anesthesia induction to Forty eight hours after surgery
Secondary	The lowest drop in SPO2 during anesthesia	The lowest value of SPO2 drop during the whole operation	Intraoperative (From the beginning to the end of anesthesia)
Secondary	Postoperative satisfaction of patients	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.	The whole experiment process was completed from the beginning of anesthesia induction to Forty eight hours after surgery