Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585306
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-14
Brief Title:
High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Sedative Gastroscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Safety of High-flow Nasal Oxygen Therapy With Different Flow Rates in Obese Patients Undergoing Sedative Gastroscopy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obese patients often have fat accumulation in the head and neck increased soft tissue in the oropharynx decreased lung compliance decreased lung volume and residual volume and some obese patients also suffer from obstructive sleep apnea Therefore obese patients may experience hypoxemia during sedative gastroscopy High-flow nasal cannula oxygen therapy HFNC can provide patients with high-flow 20-70 Lmin and adjustable oxygen concentration 21-100 through a special nasal prong catheter It has the function of warming and humidifying the air relieving pressure on the nasal mucosa maintaining airway patency and moisture reducing the risk of nasal bleeding In addition HFNC can generate positive airway pressure 3-7 cmH2O increase end-expiratory volume help with alveolar recruitment prevent atelectasis and reduce shunts The flow rate of HFNC is positively correlated with the nasopharyngeal pressure At a flow rate of 50 Lmin the nasopharyngeal pressure can exceed 3 cmH2O Obese patients are prone to upper airway obstruction under sedation or anesthesia The use of HFNC at 70 Lmin perioperatively can reduce hypoxemia in patients but discomfort in the nasopharynx may occur at this flow rate The optimal flow rate for clinical use of HFNC has not been established Meta-analysis shows that when the oxygen flow rate during painless esophagogastroduodenoscopy is greater than 30 Lmin it can significantly reduce the incidence of hypoxemia in patients Therefore for obese patients undergoing painless esophagogastroduodenoscopy the investigators propose using HFNC at three different flow rates 30 Lmin 50 Lmin and 70 Lmin to provide guidance on the optimal flow rate for clinical use of HFNC
Detailed Description:
Gastroscopy is a common method for screening and diagnosing digestive diseases with approximately 23 million cases performed in China annually However this invasive procedure can cause patients to experience pain nausea vomiting and coughing With the advancement of comfortable medical technology more patients are opting for painless gastroscopy which offers higher comfort and satisfaction levels for patients and facilitates the operation for endoscopists
During sedative gastroscopy nasal cannula oxygen therapy is commonly used to maintain oxygen levels with oxygen flow rates typically ranging from 2-6Lmin The most common complication during the procedure is hypoxia For obese patients the risk of hypoxemia is increased due to fat accumulation in the head and neck increased soft tissue in the oropharynx decreased lung compliance and volumes and potential obstructive sleep apnea Therefore appropriate oxygen therapy is crucial in preventing complications in obese patients during gastroscopy
High-flow nasal cannula oxygen therapy HFNC is a new ventilation method that provides patients with high-flow oxygen 20-70Lmin through a special nasal cannula with adjustable oxygen concentration 21-100 and warming and humidifying functionalities HFNC can alleviate mucosal ciliary pressure maintain airway patency and moisture reduce the risk of nasal bleeding and generate positive airway pressure aiding in alveolar recruitment and preventing atelectasis
Studies have shown that HFNC can reduce the occurrence of hypoxia during painless gastroscopy compared to standard oxygen therapy The positive airway pressure provided by HFNC is crucial in reducing upper airway obstruction and improving ventilation The optimal flow rate for HFNC in obese patients undergoing gastroscopy remains unclear but starting at 30Lmin has shown benefits in reducing the risk of hypoxemia without significant discomfort
Therefore the investigators propose to investigate the effects of HFNC at flow rates of 30Lmin 50Lmin and 70Lmin during painless gastroscopy in obese patients to determine the optimal flow rate that minimizes the risk of hypoxemia without causing discomfort
During sedative gastroscopy nasal cannula oxygen therapy is commonly used to maintain oxygen levels with oxygen flow rates typically ranging from 2-6Lmin The most common complication during the procedure is hypoxia For obese patients the risk of hypoxemia is increased due to fat accumulation in the head and neck increased soft tissue in the oropharynx decreased lung compliance and volumes and potential obstructive sleep apnea Therefore appropriate oxygen therapy is crucial in preventing complications in obese patients during gastroscopy
High-flow nasal cannula oxygen therapy HFNC is a new ventilation method that provides patients with high-flow oxygen 20-70Lmin through a special nasal cannula with adjustable oxygen concentration 21-100 and warming and humidifying functionalities HFNC can alleviate mucosal ciliary pressure maintain airway patency and moisture reduce the risk of nasal bleeding and generate positive airway pressure aiding in alveolar recruitment and preventing atelectasis
Studies have shown that HFNC can reduce the occurrence of hypoxia during painless gastroscopy compared to standard oxygen therapy The positive airway pressure provided by HFNC is crucial in reducing upper airway obstruction and improving ventilation The optimal flow rate for HFNC in obese patients undergoing gastroscopy remains unclear but starting at 30Lmin has shown benefits in reducing the risk of hypoxemia without significant discomfort
Therefore the investigators propose to investigate the effects of HFNC at flow rates of 30Lmin 50Lmin and 70Lmin during painless gastroscopy in obese patients to determine the optimal flow rate that minimizes the risk of hypoxemia without causing discomfort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None