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High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy

ConditionsHigh Flow Nasal CannulaBody Roundness Index
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Zhongshan Hospital

About this trial

During sedated gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce respiratory depression, airway obstruction, and decreased chest wall compliance. Patients with obesity, especially visceral fat, have poor lung and chest wall compliance, lower lung capacity and functional residual capacity, and an unbalanced ventilation-to-perfusion ratio. Thus, obese patients are at a high risk of hypoxemia.

Increasing evidence supports the use of High-flow nasal cannula (HFNC) oxygenation in obese patients during sedated gastrointestinal endoscopy. Obesity, especially visceral obesity, is an established risk factor associated with all-cause mortality. Body roundness index (BRI) is a newer anthropometric measure associated with identification of high-risk individuals. Owing to the limited evidence, we designed this unblinded randomized controlled trial to assess whether HFNC, compared to standard mask oxygenation, improves oxygenation at the end of the procedure (primary endpoint) in patients with visceral obesity.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ASA class ≤Ⅲ

Visceral obesity（body mass index≥28 and BRI ≥5.46）

Patients who will undergo sedated gastroscopy

Disqualifiers

Life-threatening heart disease or acute myocardial infarction within 6 weeks

Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema

Upper respiratory tract infection

Presence of tracheostomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Flow Nasal Cannula Oxygenation

    Procedure/Surgery

    High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%

  • Face Mask Oxygenation

    Procedure/Surgery

    conventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: High Flow Nasal Cannula OxygenationExperimental treatment 1 intervention
Group B: Mask OxygenationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of hypoxia

SpO2\<90%

Time frame
From sedation with propofol to the end of the gastroscopy

Secondary outcomes

1

Incidence of subclinical respiratory depression

90%≤SpO2\<95%

Time frame
From sedation with propofol to the end of the gastroscopy
2

Severe hypoxia

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

Time frame
From sedation with propofol to the end of the gastroscopy
3

Serious cardiac events

Hypotension: Mean arterial pressure (MAP) \< 65 mmHg; hypertension: MAP \> 90 mmHg

Time frame
Through gastroscopy completion, an average of 10-15 minutes
4

Serious adverse respiratory events

Apnea, tracheospasm, larynx spasm

Time frame
Through gastroscopy completion, an average of 10-15 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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