About this trial
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 L/min) 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 L/min, 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 L/min 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 L/min, 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 L/min, 50 L/min, and 70 L/min, to provide guidance on the optimal flow rate for clinical use of HFNC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing sedative gastroscopy
Aged over 18.
ASA classification I-III
Interincisal distance >6.5cm, no micrognathia, limited mouth opening and limited cervical spine movement
Disqualifiers
Contraindications for endoscopic procedures or patients refusing sedation/anesthesia.
Patients with allergies to propofol, eggs, soybeans, or milk.
Patients with gastrointestinal obstruction and gastric emptying disorders.
Patients with acute pharyngitis, tonsillitis, and upper respiratory tract infections.
Trial design
Parallel
Treatments tested in this trial
jaw lift, increasing oxygen flow, mask ventilation, intubation
BehavioralWhen patients develop hypoxemia, the above interventions are sequentially employed to improve their oxygenation status.
Treatment groups
Trial outcomes
Primary outcomes
incidence of hypoxia
75% ≤ SpO2 \< 90% for \<60 second
Secondary outcomes
incidences of subclinical respiratory depression and severe hypoxia
(90% ≤ SpO2 \< 95%) and (SpO2 \< 75% for any duration or 75% ≤ SpO2 \< 90% for ≥60 second)
adverse event
vomit
airway obstruction
Patients had glossoptosis, excessive oropharynx secretion, laryngeal spasm, or bronchospasm
paradoxical response
Patients displayed unpredictable movement, overexcitement, and delirium after sedation with propofol
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
XiaoLiang Wang
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Sponsor institution