Anesthesia, GeneralNCT06205212
High-flow Nasal Oxygenation During Preoxygenation and Atelectasis
A study testing high-flow nasal oxygen and facemask in people with Anesthesia, General and Pulmonary Atelectasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Atelectasis after induction of general anesthesia is common even in healthy patients and is clinically problematic, especially in obese patients. We aim to investigate whether preoxygenation with high-flow nasal oxygen during anesthesia induction reduces atelectasis in obese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, General, Pulmonary Atelectasis
- What is being tested?
- high-flow nasal oxygen and facemask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Oct 2023to 10 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients undergoinig surgery under general anesthesia with a BMI of 30 kg/m2 or greater who have given informed consent
Who cannot join
- surgery time less than 2 hours
- Nasotracheal intubation
- Severe cardiac or respiratory disease
- History of difficult airway
- History of a surgery or anatomical anomaly in the head and neck
- History of Inability to breathe through nose
- Gastric reflux disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
SMG - SNU Boramae Medical Center
Seoul, 07061
Tae Kyong Kim, MD, 82-2-2072-2467, ktkktk@gmail.com
About this study
Official title: The Effect of High-flow Nasal Cannula Applied During Preoxygenation for Prevention of Atelectasis in Patients With Obesity Undergoing General Anesthesia: A Randomized Controlled Trial
Atelectasis after induction of general anesthesia is common even in healthy patients and is clinically problematic, especially in obese patients. We aim to investigate whether preoxygenation with high-flow nasal oxygen during anesthesia induction reduces atelectasis in obese patients.
- Conditions
- Anesthesia, General, Pulmonary Atelectasis
- Being tested
- high-flow nasal oxygen, facemask
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-flow nasal oxygenOther
preoxygenation using high-flow nasal oxygen, FiO2 1.0, 40 L/min, 3 min
facemaskOther
preoxygenation using facemask, FIO2 1.0, fresh gas flow 10 L/min, 3 min
| Study group | Role | What they receive |
|---|---|---|
| facemask | Active comparator | preoxygenation using a conventional facemask Receives: Other: facemask |
| high-flow nasal oxygen | Experimental | preoxygenation using high-flow nasal cannula oxygen Receives: Other: high-flow nasal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound score
modified LUSS
Measured: Immediately after anesthesia induction
Secondary outcomes (9)
Incidence of atelectasis
Measured: Immediately after anesthesia induction
PaO2 to FiO2 ratio and PaCO2
Measured: Immediately after anesthesia induction
Hemodynamic variables
Blood pressure, heart rate, pulse oximetry
Measured: During anesthesia induction
Patient Satisfaction Score
Measured: During preoxygenation
Lung ultrasound score
Measured: In the PACU after surgery
Incidence of Spo2 less than 95%
Measured: during 48 hours postoperatively
Maximum body temperature
Measured: during hospitalization up to 1 week
Incidence of postoperative pulmonary complications
Measured: during hospitalization up to 1 week
length of hospital stay
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start10 Oct 2023
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
- Investigators
- TAE KYONG KIM, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205212
- Sponsor's protocol ID
- HFNO_PRE
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 12 Jan 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-flow Nasal Cannula Applied During Preoxygenation for Prevention of Atelectasis in Patients With Obesity Undergoing General Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06205212
- Acronym / sponsor ID
- HFNO_PRE
- Conditions
- Anesthesia, General, Pulmonary Atelectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 12 Jan 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.
Atelectasis after induction of general anesthesia is common even in healthy patients and is clinically problematic, especially in obese patients. We aim to investigate whether preoxygenation with high-flow nasal oxygen during anesthesia induction reduces atelectasis in obese patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| facemask | Active comparator | Other: facemaskpreoxygenation using a conventional facemask |
| high-flow nasal oxygen | Experimental | Other: high-flow nasal oxygenpreoxygenation using high-flow nasal cannula oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients undergoinig surgery under general anesthesia with a BMI of 30 kg/m2 or greater who have given informed consent
Key exclusion criteria (7 listed)
- surgery time less than 2 hours
- Nasotracheal intubation
- Severe cardiac or respiratory disease
- History of difficult airway
- History of a surgery or anatomical anomaly in the head and neck
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 |
|---|---|---|
| high-flow nasal oxygenpreoxygenation using high-flow nasal oxygen, FiO2 1.0, 40 L/min, 3 min | Other | high-flow nasal oxygen |
| facemaskpreoxygenation using facemask, FIO2 1.0, fresh gas flow 10 L/min, 3 min | Other | facemask |
Primary outcome
Lung ultrasound score
Time frame: Immediately after anesthesia induction
modified LUSS
9 secondary outcomes
Incidence of atelectasis
Time frame: Immediately after anesthesia induction
PaO2 to FiO2 ratio and PaCO2
Time frame: Immediately after anesthesia induction
Hemodynamic variables
Time frame: During anesthesia induction
Patient Satisfaction Score
Time frame: During preoxygenation
Lung ultrasound score
Time frame: In the PACU after surgery
Incidence of Spo2 less than 95%
Time frame: during 48 hours postoperatively
Maximum body temperature
Time frame: during hospitalization up to 1 week
Incidence of postoperative pulmonary complications
Time frame: during hospitalization up to 1 week
length of hospital stay
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
TAE KYONG KIM principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-flow nasal oxygen and facemask in people with Anesthesia, General and Pulmonary Atelectasis, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 7 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 12 Jan 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 South Korea. 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 TAE KYONG KIM (82-2-870-2519, ktkktk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ultrasound score (time frame: Immediately after anesthesia induction). 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 12 Jan 2024.