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

NCT05835661 | Unknown

• 1 other identifier: YXLL-KY-2023(001)
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication; Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• The lowest drop in SPO2 during anesthesia

  Intraoperative (From the beginning to the end of anesthesia)

• Postoperative satisfaction of patients

  The whole experiment process was completed from the beginning of anesthesia induction to Forty eight hours after surgery

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients are more prone to sudden drop of blood oxygen, 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

YOU Qi

Jinan, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

According to the preliminary results, the rate of pharyngeal pain was 20% in the transoral group and 60% in the nasal group.Bilateral test α=0.05, power=0.80, considering the 20% shedding rate, the sample size was calculated by PASS software. According to the postoperative pharyngeal pain rate, the required sample size of each group was 29, and the total sample size was 58.According to the minimum oxygen saturation in the two groups, the required sample size for each group was 123, and the total sample size was 246 cases.Since both of the two research indicators are major research indicators, it is recommended to select a larger sample size of 246 cases, which can meet the research requirements.

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• ChuanYu Sun, master

  Department director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

You Qi, master

CONTACT

19553100910; 312011097@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 28, 2023
• Study Start: April 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)