High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Sedative Gastroscopy

NCT06585306 | Recruiting DMC

• 1 other identifier: KY20240419-07
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hypoxia; Obesity; Gastrostomy

Keywords

Obese patients; sedative gastroscopy; HFNC

Outcome Measures

Primary Outcomes (1)

• incidence of hypoxia

  75% ≤ SpO2 \< 90% for \<60 second

  6 mintues before gastroscopy completion

Secondary Outcomes (5)

• incidences of subclinical respiratory depression and severe hypoxia

  6 mintues before gastroscopy completion

• adverse event

  6 mintues before gastroscopy completion

• airway obstruction

  6 mintues before gastroscopy completion

• paradoxical response

  6 mintues before gastroscopy completion

• airway intervention

  6 mintues before gastroscopy completion

Study Arms (3)

HFNC30L/min

EXPERIMENTAL

patients pre-oxygenation with pure oxygen at 30L/min for 1 minute, followed by sedation with slightly slow but steady breathing, disappearance of eyelash reflex, and continued oxygen flow at 30 L/min

Behavioral: jaw lift, increasing oxygen flow, mask ventilation, intubation

HFNC50L/min

EXPERIMENTAL

patients pre-oxygenation with pure oxygen at 30L/min for 1 minute, followed by sedation with slightly slow but steady breathing, adjustment of oxygen flow to 50L/min after disappearance of eyelash reflex.

Behavioral: jaw lift, increasing oxygen flow, mask ventilation, intubation

HFNC70L/min

EXPERIMENTAL

patients pre-oxygenation with pure oxygen at 30L/min for 1 minute, followed by sedation with slightly slow but steady breathing, adjustment of oxygen flow to 70L/min after disappearance of eyelash reflex.

Behavioral: jaw lift, increasing oxygen flow, mask ventilation, intubation

Interventions

jaw lift, increasing oxygen flow, mask ventilation, intubation BEHAVIORAL

When patients develop hypoxemia, the above interventions are sequentially employed to improve their oxygenation status.

HFNC30L/min; HFNC50L/min; HFNC70L/min

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Compliance with ethics, patient willing to participate in the trial, signed informed consent form

You may not qualify if:

• 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.
• : Patients with acute exacerbations of respiratory diseases such as asthma, bronchitis, and COPD. 6. Patients with acute arrhythmias and severe heart disease (congenital, valvular disease). 7. Patients requiring replacement therapy for severe liver or kidney dysfunction.
• \. Patients with severe mental illnesses requiring medication to control symptoms.
• \. Patients with moderate to severe anemia, coagulation disorders, and hematological diseases. 10. Patients with severe nasal congestion caused by nasal cavity lesions. 11. Pregnant and lactating patients.

Sponsors & Collaborators

• XiaoLiang Wang: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Hypoxia; Obesity

Interventions

Intubation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Xiaoliang Wang

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Jing Hu

CONTACT

15366110201; hujingmz@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician of the Department of Anesthesiology, Perioperative and Pain Medicine, Nanjing First Hospital, Nanjing Medical University, Nanjing, China

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: September 5, 2024
• Study Start: October 23, 2024
• Primary Completion: September 20, 2025
• Study Completion: October 20, 2025
• Last Updated: April 1, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)