Nasopharyngeal Airway Combined With Nasal High-flow Oxygen Therapy During Painless Gastroscopy in Obesity Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing painless gastroscopy;

Patients with an age greater than 18 years old;

American Society of Anesthesiologists (ASA) physical status classification from Grade I to Grade III;

Body Mass Index (BMI) greater than 28 kg/m²

Disqualifiers

Patients with contraindications to endoscopic procedures or those who refuse sedation/anesthesia;

Patients allergic to propofol, eggs, soybeans, milk, etc.;

Patients with gastrointestinal tract obstruction and gastric emptying disorders;

Patients with acute pharyngitis, tonsillitis, and upper respiratory tract infections;

Trial design

Design model

Parallel

Treatments tested in this trial

  • NPA

    Device

    After sedation, the nasopharyngeal airway (NPA) is inserted when the patient's breathing becomes slightly slow but stable and the eyelash reflex disappears.

Treatment groups

364 Participants
are divided into 2 treatment groups
Group A: HFNC30L/minNo intervention 0 interventions
Group B: HFNC30L/min AND NPAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

incidence of hypoxia

75% ≤ SpO2 \< 90% for \<60 s

Time frame
6 mintues after gastroscopy completion

Secondary outcomes

1

incidence of subclinical respiratory depression

90% ≤ SpO2 \< 95%

Time frame
6 mintues after gastroscopy completion
2

incidence of severe hypoxia

SpO2 \< 75% for any duration or 75% ≤ SpO2 \< 90% for ≥60 s

Time frame
6 mintues after gastroscopy completion
3

periprocedural complications

vomit and nausea

Time frame
6 mintues after gastroscopy completion
4

airway associated complications

incidence of patients with glossoptosis, excessive oropharynx secretion, laryngeal spasm,bronchospam

Time frame
6 mintues after gastroscopy completion

Other outcomes

Sponsors and contacts

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