Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 1:21 PM
Study NCT ID:
NCT06966934
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients
Sponsor:
Nanjing First Hospital, Nanjing Medical University
Organization:
Study Overview
Official Title:
The Application of Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Patients With Obesity
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastroscopy is a commonly used, direct, and reliable method for screening and diagnosing digestive tract diseases. However, as an invasive examination, it can cause adverse reactions such as pain, nausea, vomiting, and choking cough in patients. Compared with ordinary gastroscopy, painless gastroscopy offers higher comfort and satisfaction for patients and greater convenience for endoscopists during operation.
The most common complication of painless gastroscopy diagnosis and treatment is hypoxia. High-flow nasal cannulala (HFNC) provides a higher oxygen concentration and flow rate than an ordinary nasal catheter. It has the functions of heating and humidifying, which can relieve the pressure on the nasal mucosa cilia, keep the airway unobstructed and moist, and reduce the risk of epistaxis. Due to changes in airway anatomical structures such as fat accumulation in the head and neck and hyperplasia of oropharyngeal soft tissues, obese patients are more prone to hypoxia during gastroscopy under sedation. Therefore, HFNC is often used to reduce the occurrence of hypoxia.
The nasopharyngeal airway (NPA) is used to maintain the patency of the upper respiratory tract and is suitable for patients with spontaneous breathing but partial obstruction of the upper respiratory tract. It is worth exploring how effective the combination of HFNC and NPA is in improving hypoxemia in obese patients during sedation.
The most common complication of painless gastroscopy diagnosis and treatment is hypoxia. High-flow nasal cannulala (HFNC) provides a higher oxygen concentration and flow rate than an ordinary nasal catheter. It has the functions of heating and humidifying, which can relieve the pressure on the nasal mucosa cilia, keep the airway unobstructed and moist, and reduce the risk of epistaxis. Due to changes in airway anatomical structures such as fat accumulation in the head and neck and hyperplasia of oropharyngeal soft tissues, obese patients are more prone to hypoxia during gastroscopy under sedation. Therefore, HFNC is often used to reduce the occurrence of hypoxia.
The nasopharyngeal airway (NPA) is used to maintain the patency of the upper respiratory tract and is suitable for patients with spontaneous breathing but partial obstruction of the upper respiratory tract. It is worth exploring how effective the combination of HFNC and NPA is in improving hypoxemia in obese patients during sedation.
Detailed Description:
Gastroscopy is a commonly used, direct, and reliable method for screening and diagnosing digestive tract diseases. However, as an invasive examination, it can cause adverse reactions such as pain, nausea, vomiting, and choking cough in patients. With the promotion of comfortable medical technology, more patients choose painless gastroscopy. Compared with ordinary gastroscopy, patients have a higher level of comfort and satisfaction, and it is more convenient for endoscopists to operate. Obesity is a chronic and multisystemic disease, and its prevalence is on the rise worldwide. It is estimated that by 2035, the prevalence of obesity will increase from 14% of the world's population to 24% in 2035. Due to the relationship between obesity and obesity-related comorbidities (such as dyslipidemia, hypertension, diabetes, cardiovascular diseases, and even certain types of cancer), it is necessary and important to actively control and treat obesity. Therefore, it is strongly recommended that such people undergo gastroscopy, whether it is for preoperative examination of bariatric surgery or for the diagnosis and treatment of gastrointestinal diseases. With the increase in the number of obese patients, the proportion of the patient group undergoing sedated gastrointestinal endoscopy has also increased. During painless gastroscopy, respiratory depression has always been one of the common adverse reactions. The incidence of hypoxia in obese patients during sedated gastroscopy is higher than that in patients with normal body weight, and it increases with the increase of the body mass index. Therefore, high-flow nasal cannulala (HFNC) is often used clinically to reduce the occurrence of hypoxia in obese patients during painless gastroscopy.
HFNC is a new type of ventilation method. It can provide patients with a high flow rate (20-70L/min) of oxygen through a special nasal cannula, and the oxygen concentration can be adjusted (21%-100%). It has the functions of heating and humidifying, which can relieve the pressure on the nasal mucosa cilia, keep the airway unobstructed and moist, and reduce the risk of epistaxis. In addition, HFNC can generate positive airway pressure (3-7cmH2O), increase the end-expiratory volume, help with alveolar re-expansion, prevent atelectasis, and reduce shunt. Obese patients have fat accumulation in the head and neck, hyperplasia of oropharyngeal soft tissues, reduced lung compliance, reduced lung volume and functional residual capacity. Some obese patients also suffer from obstructive sleep apnea, which increases the risk of hypoxemia in obese patients .
The Nasopharyngeal Airway (NPA) is a commonly used ventilation assistance tool. It is a soft and curved tube that is inserted through the nasal cavity so that the front end of the tube is located in the pharynx, bypassing the parts where obstruction may occur (such as the backward displacement of the tongue root, etc.), thus establishing a gas passage to allow air to smoothly pass through the upper respiratory tract into the trachea and lungs, ensuring the normal ventilation of patients. It is suitable for patients with spontaneous breathing but partial obstruction of the upper respiratory tract. For obese patients, NPA has significant advantages in reducing airway obstruction, being easy to insert, having good tolerance, not affecting oral cavity operations, reducing respiratory resistance, and reducing complications. It is an effective tool for managing the airway of obese patients. Therefore, the investigators propose the hypothesis that the use of NPA combined with HFNC during painless gastroscopy in obese patients can further reduce the incidence of hypoxia in obese patients.
HFNC is a new type of ventilation method. It can provide patients with a high flow rate (20-70L/min) of oxygen through a special nasal cannula, and the oxygen concentration can be adjusted (21%-100%). It has the functions of heating and humidifying, which can relieve the pressure on the nasal mucosa cilia, keep the airway unobstructed and moist, and reduce the risk of epistaxis. In addition, HFNC can generate positive airway pressure (3-7cmH2O), increase the end-expiratory volume, help with alveolar re-expansion, prevent atelectasis, and reduce shunt. Obese patients have fat accumulation in the head and neck, hyperplasia of oropharyngeal soft tissues, reduced lung compliance, reduced lung volume and functional residual capacity. Some obese patients also suffer from obstructive sleep apnea, which increases the risk of hypoxemia in obese patients .
The Nasopharyngeal Airway (NPA) is a commonly used ventilation assistance tool. It is a soft and curved tube that is inserted through the nasal cavity so that the front end of the tube is located in the pharynx, bypassing the parts where obstruction may occur (such as the backward displacement of the tongue root, etc.), thus establishing a gas passage to allow air to smoothly pass through the upper respiratory tract into the trachea and lungs, ensuring the normal ventilation of patients. It is suitable for patients with spontaneous breathing but partial obstruction of the upper respiratory tract. For obese patients, NPA has significant advantages in reducing airway obstruction, being easy to insert, having good tolerance, not affecting oral cavity operations, reducing respiratory resistance, and reducing complications. It is an effective tool for managing the airway of obese patients. Therefore, the investigators propose the hypothesis that the use of NPA combined with HFNC during painless gastroscopy in obese patients can further reduce the incidence of hypoxia in obese patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: