Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06585306

Study on the Safety of High-flow Nasal Oxygen Therapy With Different Flow Rates in Obese Patients Undergoing Sedative Gastroscopy

Led by XiaoLiang Wang · Updated on 2025-04-01

864

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Obese patients undergoing sedative gastroscopy often face increased risks of hypoxemia due to fat accumulation in the head and neck, increased soft tissue in the oropharynx, reduced lung compliance and volumes, and sometimes obstructive sleep apnea. This research aims to evaluate the safety and optimal flow rate of high-flow nasal cannula oxygen therapy (HFNC) at 30 L/min, 50 L/min, and 70 L/min in obese patients during painless gastroscopy to reduce hypoxia risk without causing discomfort. The study compares three intervention groups where patients receive HFNC oxygen therapy starting with pre-oxygenation at 30 L/min for one minute, then sedation is administered. Oxygen flow is maintained at 30 L/min in one group, increased to 50 L/min in another, and to 70 L/min in the last group after sedation begins. If hypoxemia occurs, behavioral interventions such as jaw lift, increased oxygen flow, mask ventilation, and intubation may be used sequentially to improve oxygenation. Participants will undergo assessments during the procedure focusing on the incidence of hypoxia and related complications such as respiratory depression, airway obstruction, adverse events, paradoxical responses, and airway interventions within six minutes before gastroscopy completion. The study involves monitoring oxygen levels and patient safety throughout the procedure to determine the best HFNC flow rate. The total participation duration corresponds with the gastroscopy procedure and monitoring period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing sedative gastroscopy
  • Aged over 18
  • ASA classification I-III
  • Interincisal distance greater than 6.5 cm, no micrognathia, limited mouth opening or limited cervical spine movement
  • Willing to participate and signed informed consent form
Not Eligible

You will not qualify if you...

  • Contraindications for endoscopic procedures or refusal of sedation/anesthesia
  • Allergies to propofol, eggs, soybeans, or milk
  • Gastrointestinal obstruction or gastric emptying disorders
  • Acute pharyngitis, tonsillitis, or upper respiratory tract infections
  • Acute exacerbations of respiratory diseases like asthma, bronchitis, or COPD
  • Acute arrhythmias or severe heart disease including congenital or valvular conditions
  • Severe liver or kidney dysfunction requiring replacement therapy
  • Severe mental illnesses requiring medication
  • Moderate to severe anemia, coagulation disorders, or hematological diseases
  • Severe nasal congestion caused by nasal cavity lesions
  • Pregnant or lactating patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single session during gastroscopy procedure

Participants receive high-flow nasal oxygen therapy at different flow rates during sedative gastroscopy to prevent hypoxemia.

1 procedure visit (in-person)

Follow-up

Duration - Up to 6 minutes after gastroscopy completion

Participants are monitored for adverse events and respiratory status immediately following the gastroscopy procedure.

1 post-procedure monitoring period

Trial Site Locations

Total: 1 location

1

Nanjing First Hospital

Nanjing, Jiangsu, China, 210006

Actively Recruiting

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Research Team

J

Jing Hu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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