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RecruitingNCT06562660Updated Sep 20, 2024

The Effect of Mask Combined With High Flow Oxygen on Preoxygenation During Induction of General Anesthesia in Obese Patients

An interventional study of apnoeic in Obese, sponsored by Henan Provincial People's Hospital. Recruiting at 1 site in China. Open to male participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by Henan Provincial People's Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

There is a risk of airway-related incidents during anaesthesia associated with obesity. High-flow nasal oxygen is advocated for perioperative preoxygenation in obese patients to reduce airway adverse reactions. However, there have been no reports on whether smoking behaviors have an impact on obese men's Apnoeic oxygenation with high-flow nasal.This study compared the effects of smoking on the duration of safe apnoea times in obese males.

Read the detailed description

All patients were were divided into two groups based on smoking status: smokers(S groups), and never smokers(NS groups). Those in the smoking group were current smokers, while those in the nonsmoking group had never smoked. Both groups of patients were induced with intravenous anesthesia and received 5 minutes of high flow nasal oxygen (60 L min) prior to induction.After induction of anaesthesia, the patients were apnoeic until peripheral oxygen saturation decreased to 95 %.

02

Conditions studied

  • Obese

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Keywords

  • High-Flow Nasal Oxygen
  • Obese Men
  • Smoking
03

In context

Obesity

6,297 studies on the registry are indexed under Obesity; 1,693 are open to participants now.

This study's planned enrollment of 60 is below the median of 78 across 4,879 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Henan Provincial People's Hospital is the lead sponsor of 63 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Participants ranged in age from 18 to 80 with BMI≥30 kg/m2.
  2. Participants are male obese patients undergoing elective non-thoracic surgery

Exclusion criteria

Exclusion Criteria :

  1. patients were kept awake during the intubation due to cervical spine pathology.
  2. Patients with unstable hemodynamics.
  3. Patients with airway inflammatory diseases, including asthma, chronic obstructive pulmonary disease (COPD), lung cancer, pulmonary fibrosis and cystic fibrosis.
  4. Patients with upper respiratory infection and nasal blockage.
  5. Patients with Hypersensitivity to the drug.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Smoking group

    In the Smoking group, the HFNC was performed after the patient lost spontaneous breathing until the end-tidal oxygen concentration reached 95 %. record the patient 's safe apnea time.

    Device: apnoeic

  • No intervention
    never smoking

    no intervention

Interventions

  • Deviceapnoeic

    In group S, High-Flow Nasal Oxygen was performed after the patient lost spontaneous breathing until the end-expiratory oxygen concentration reached 95 %.

06

What researchers measure

Primary outcomes

  1. the safe apnoea times

    Investigators will record the time of oxygen saturation drop to 95 % during intubation.

    Time frame: 5-minute

Secondary outcomes

  1. the Pao2 levels

    the Pao2 levels after 5-minute pre oxygenation with high flow nasal oxygen in two groups of patients.

    Time frame: 5-minute

07

Study locations

1 of 1 sites recruiting
  • Wanghuabing
    Zhengzhou, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06562660
Lead sponsor
Henan Provincial People's Hospital
Responsible party
Sponsor
First posted
Aug 20, 2024
Start date
May 1, 2024
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Sep 20, 2024

Study contacts

huabing wang
Contact
642221283@qq.com
+8618538706687
jiaqiang zhang
Contact
Jiaqiang197628@163.com
+8613937121360
jiaqiang zhang
study director · Chief physician

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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