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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiaoLiang Wang

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

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

Treatment groups

864 Participants
are divided into 3 treatment groups
Group A: HFNC30L/minExperimental treatment 1 intervention
Group B: HFNC50L/minExperimental treatment 1 intervention
Group C: HFNC70L/minExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

incidence of hypoxia

75% ≤ SpO2 \< 90% for \<60 second

Time frame
6 mintues before gastroscopy completion

Secondary outcomes

1

incidences of subclinical respiratory depression and severe hypoxia

(90% ≤ SpO2 \< 95%) and (SpO2 \< 75% for any duration or 75% ≤ SpO2 \< 90% for ≥60 second)

Time frame
6 mintues before gastroscopy completion
2

adverse event

vomit

Time frame
6 mintues before gastroscopy completion
3

airway obstruction

Patients had glossoptosis, excessive oropharynx secretion, laryngeal spasm, or bronchospasm

Time frame
6 mintues before gastroscopy completion
4

paradoxical response

Patients displayed unpredictable movement, overexcitement, and delirium after sedation with propofol

Time frame
6 mintues before gastroscopy completion

Other outcomes

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