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

NCT06562660 | Recruiting DMC

• 1 other identifier: HenanPPH-wanghuabing
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obese

Keywords

High-Flow Nasal Oxygen; Obese Men; Smoking

Outcome Measures

Primary Outcomes (1)

• the safe apnoea times

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

  5-minute

Secondary Outcomes (1)

• the Pao2 levels

  5-minute

Study Arms (2)

Smoking group

EXPERIMENTAL

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

never smoking

NO INTERVENTION

no intervention

Interventions

apnoeic DEVICE

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

Smoking group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Wanghuabing

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Obesity; Smoking

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• jiaqiang zhang

  Chief physician

  STUDY DIRECTOR

Central Study Contacts

huabing wang

CONTACT

+8618538706687; 642221283@qq.com

jiaqiang zhang

CONTACT

+8613937121360; Jiaqiang197628@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A total of 60 male obese patients undergoing elective non-thoracic surgery were divided into two groups (n=30) based on smoking status: smokers(S groups), and never smokers(NS groups). Those in the smoking group were current or past smokers, while those in the nonsmoking group had never smoked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 60 male obese patients undergoing elective non-thoracic surgery were divided into two groups (n=30) based on smoking status: smokers(S groups), and never smokers(NS groups). Those in the smoking group were current or past smokers, while those in the nonsmoking group had never smoked.

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 20, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)