ObeseNCT06562660
The Effect of Mask Combined With High Flow Oxygen on Preoxygenation During Induction of General Anesthesia in Obese Patients
A study testing apnoeic in people with Obese, run by Henan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obese
- What is being tested?
- apnoeic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants ranged in age from 18 to 80 with BMI≥30 kg/m2.
- Participants are male obese patients undergoing elective non-thoracic surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wanghuabing
Zhengzhou
huabing wang, +8618538706687, 642221283@qq.com
About this study
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 %.
- Conditions
- Obese
- Being tested
- apnoeic
- Keywords
- High-Flow Nasal Oxygen, Obese Men, Smoking
- Medical subject headings
- Obesity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apnoeicDevice
In group S, High-Flow Nasal Oxygen was performed after the patient lost spontaneous breathing until the end-expiratory oxygen concentration reached 95 %.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: apnoeic |
| never smoking | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the safe apnoea times
Investigators will record the time of oxygen saturation drop to 95 % during intubation.
Measured: 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.
Measured: 5-minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 May 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jiaqiang zhang, Study director, Chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562660
- Sponsor's protocol ID
- HenanPPH-wanghuabing
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mask Combined With High Flow Oxygen on Preoxygenation During Induction of General Anesthesia in Obese Patients
- ClinicalTrials.gov ID
- NCT06562660
- Acronym / sponsor ID
- HenanPPH-wanghuabing
- Conditions
- Obese
- Keywords
- High-Flow Nasal Oxygen, Obese Men, Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 %.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smoking group | Experimental | Device: apnoeicIn 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. |
| never smoking | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants ranged in age from 18 to 80 with BMI≥30 kg/m2.
- Participants are male obese patients undergoing elective non-thoracic surgery
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apnoeicIn group S, High-Flow Nasal Oxygen was performed after the patient lost spontaneous breathing until the end-expiratory oxygen concentration reached 95 %. | Device | Smoking group |
Primary outcome
the safe apnoea times
Time frame: 5-minute
Investigators will record the time of oxygen saturation drop to 95 % during intubation.
1 secondary outcome
the Pao2 levels
Time frame: 5-minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jiaqiang zhang study director
Chief physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apnoeic in people with Obese, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huabing wang (+8618538706687, 642221283@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the safe apnoea times (time frame: 5-minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.