Electroconvulsive Therapy Treated PatientsNCT07093372
LMA vs High-flow Nasal Oxygen During ECT in Obese Patients
A study testing Laryngeal Mask Airway and High-Flow Nasal Cannula in people with Electroconvulsive Therapy Treated Patients and Obesity, run by Eulji University Hospital.
Trial summary
This study aims to compare two oxygenation strategies-laryngeal mask airway (LMA) ventilation and high-flow nasal cannula (HFNC)-during electroconvulsive therapy (ECT) in obese patients. Due to their physiological characteristics, obese patients are at increased risk of hypoxia during ECT under general anesthesia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Electroconvulsive Therapy Treated Patients, Obesity
- What is being tested?
- Laryngeal Mask Airway and High-Flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patients scheduled to undergo ≥ 4 electroconvulsive therapy (ECT) sessions
- Body mass index (BMI) ≥ 30 kg/m² (WHO obesity classification)
- American Society of Anesthesiologists (ASA) physical status class I to III
- Provided written informed consent (by patient or legal guardian)
Who cannot join
- Patients under 18 years of age
- Patients with ASA class IV or V
- Patients with anticipated dental injury risk that precludes use of a laryngeal mask airway
- Patients or guardians who refuse participation
About this study
Official title: Comparison Between Laryngeal Mask and High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Electroconvulsive Therapy
This study aims to compare two oxygenation strategies-laryngeal mask airway (LMA) ventilation and high-flow nasal cannula (HFNC)-during electroconvulsive therapy (ECT) in obese patients. Due to their physiological characteristics, obese patients are at increased risk of hypoxia during ECT under general anesthesia.
Adult patients with a body mass index (BMI) ≥30 who are scheduled to undergo ECT will participate. Each participant will receive both oxygenation strategies in a fixed alternating order during four consecutive ECT sessions. The procedures will follow standard anesthesia protocols.
During the ECT procedures and the 30-minute recovery period in the post-anesthesia care unit, we will monitor the occurrence of hypoxia (SpO₂ <92%), ventilator parameters, vital signs, postoperative confusion within 24 hours, and any reports of dental discomfort. This information will help assess the safety and clinical utility of each oxygenation method for obese patients receiving ECT.
Read the detailed description
Obesity is a known risk factor for perioperative hypoxia due to physiological changes such as increased airway resistance, reduced functional residual capacity, and elevated oxygen demand. These risks are amplified in patients undergoing electroconvulsive therapy (ECT) under general anesthesia, where periods of apnea can result in critical oxygen desaturation.
While laryngeal mask airways (LMAs) and high-flow nasal cannula (HFNC) therapy are both recommended strategies to maintain oxygenation during anesthesia, their comparative effectiveness in obese patients undergoing ECT has not been well established. LMAs provide direct airway access and enable positive pressure ventilation but carry a risk of dental trauma. HFNC offers a non-invasive alternative that may prolong safe apnea time, though its oxygenation efficacy during ECT remains unclear.
This study aims to evaluate the safety and effectiveness of LMA versus HFNC in preventing hypoxia during ECT in obese patients. Using a within-subject crossover design, each participant will receive both interventions in alternating ECT sessions. This trial will help determine the optimal airway management strategy for minimizing peri-procedural hypoxia in this high-risk population.
The outcome will be assessed during each ECT session as part of a crossover design. All participants will undergo both LMA and HFNC interventions in alternating sessions (LMA during sessions 1 and 3, HFNC during sessions 2 and 4). Oxygen support beyond the assigned method will be recorded when clinically indicated.
- Being tested
- Laryngeal Mask Airway, High-Flow Nasal Cannula
- Keywords
- electroconvulsive therapy, obesity, ventilation strategy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask AirwayDevice
A supraglottic airway device (i-gel) used to deliver oxygen and assist ventilation during electroconvulsive therapy (ECT) in obese patients. The device is inserted after induction of general anesthesia and removed after spontaneous respiration is restored.
High-Flow Nasal CannulaDevice
A heated and humidified oxygen delivery system that provides high flow oxygen through nasal prongs. In this study, it is used throughout the ECT procedure to maintain oxygenation in obese patients without the need for invasive airway insertion.
| Study group | Role | What they receive |
|---|---|---|
| Alternating LMA and HFNC Oxygen Therapy | Experimental | All participants will undergo laryngeal mask airway (LMA) ventilation during ECT sessions 1 and 3, and high-flow nasal cannula (HFNC) oxygen therapy during sessions 2 and 4. Receives: Device: Laryngeal Mask Airway; Device: High-Flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxia (SpO₂ <92%) during ECT
Measured: During each ECT session (approximately 10-15 minutes)
Secondary outcomes (11)
incidence of hypoxia during recovery
Measured: During post-anesthesia recovery (approximately 30-40 minutes)
Lowest peripheral oxygen saturation
Measured: From preoxygenation to recovery room discharge (approximately 1 hours)
Duration of hypoxia during ECT and recovery
Measured: From preoxygenation to recovery room discharge (approximately 1 hours)
Lowest end-tidal CO₂ before ECT stimulation
Measured: Baseline (immediately prior to ECT stimulation)
Percent (%) increase in heart rate after ECT stimulation
Measured: During each ECT session (approximately 10-15 minutes)
Duration of seizure (motor and EEG)
Measured: During each ECT session (approximately 10-15 minutes)
Postictal Suppression Index (PSI)
Measured: During each ECT session (approximately 10-15 minutes)
Husain EEG Seizure Quality Scale
Measured: During each ECT session (approximately 10-15 minutes)
Airway management failure rate (LMA reinsertion or intubation required)
Measured: During each ECT session (approximately 10-15 minutes)
Number of participants with dental discomfort or tooth injury within 24 hours after ECT
Measured: Within 24 hours after each ECT session
Number of participants requiring additional oxygen support during ECT
Measured: During each ECT session (approximately 10-15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electroconvulsive Therapy Treated PatientsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo LMA in session 1 and 3, and HFNC in session 2 and 4.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eulji University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunjae Im, Eulji University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093372
- Sponsor's protocol ID
- UEMC 2025-06-004-001
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Laryngeal Mask and High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT07093372
- Acronym / sponsor ID
- UEMC 2025-06-004-001
- Keywords
- electroconvulsive therapy, obesity, ventilation strategy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Eulji University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 30 Jul 2025 (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.
This study aims to compare two oxygenation strategies-laryngeal mask airway (LMA) ventilation and high-flow nasal cannula (HFNC)-during electroconvulsive therapy (ECT) in obese patients. Due to their physiological characteristics, obese patients are at increased risk of hypoxia during ECT under general anesthesia.
Adult patients with a body mass index (BMI) ≥30 who are scheduled to undergo ECT will participate. Each participant will receive both oxygenation strategies in a fixed alternating order during four consecutive ECT sessions. The procedures will follow standard anesthesia protocols.
During the ECT procedures and the 30-minute recovery period in the post-anesthesia care unit, we will monitor the occurrence of hypoxia (SpO₂ <92%), ventilator parameters, vital signs, postoperative confusion within 24 hours, and any reports of dental discomfort. This information will help assess the safety and clinical utility of each oxygenation method for obese patients receiving ECT.
Detailed description
Obesity is a known risk factor for perioperative hypoxia due to physiological changes such as increased airway resistance, reduced functional residual capacity, and elevated oxygen demand. These risks are amplified in patients undergoing electroconvulsive therapy (ECT) under general anesthesia, where periods of apnea can result in critical oxygen desaturation.
While laryngeal mask airways (LMAs) and high-flow nasal cannula (HFNC) therapy are both recommended strategies to maintain oxygenation during anesthesia, their comparative effectiveness in obese patients undergoing ECT has not been well established. LMAs provide direct airway access and enable positive pressure ventilation but carry a risk of dental trauma. HFNC offers a non-invasive alternative that may prolong safe apnea time, though its oxygenation efficacy during ECT remains unclear.
This study aims to evaluate the safety and effectiveness of LMA versus HFNC in preventing hypoxia during ECT in obese patients. Using a within-subject crossover design, each participant will receive both interventions in alternating ECT sessions. This trial will help determine the optimal airway management strategy for minimizing peri-procedural hypoxia in this high-risk population.
The outcome will be assessed during each ECT session as part of a crossover design. All participants will undergo both LMA and HFNC interventions in alternating sessions (LMA during sessions 1 and 3, HFNC during sessions 2 and 4). Oxygen support beyond the assigned method will be recorded when clinically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo LMA in session 1 and 3, and HFNC in session 2 and 4.
| Arm | Type | Receives |
|---|---|---|
| Alternating LMA and HFNC Oxygen Therapy | Experimental | Device: Laryngeal Mask Airway, Device: High-Flow Nasal CannulaAll participants will undergo laryngeal mask airway (LMA) ventilation during ECT sessions 1 and 3, and high-flow nasal cannula (HFNC) oxygen therapy during sessions 2 and 4. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patients scheduled to undergo ≥ 4 electroconvulsive therapy (ECT) sessions
- Body mass index (BMI) ≥ 30 kg/m² (WHO obesity classification)
- American Society of Anesthesiologists (ASA) physical status class I to III
- Provided written informed consent (by patient or legal guardian)
Key exclusion criteria (4 listed)
- Patients under 18 years of age
- Patients with ASA class IV or V
- Patients with anticipated dental injury risk that precludes use of a laryngeal mask airway
- Patients or guardians who refuse participation
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 |
|---|---|---|
| Laryngeal Mask AirwayA supraglottic airway device (i-gel) used to deliver oxygen and assist ventilation during electroconvulsive therapy (ECT) in obese patients. The device is inserted after induction of general anesthesia and removed after spontaneous respiration is restored. | Device | Alternating LMA and HFNC Oxygen Therapy |
| High-Flow Nasal CannulaA heated and humidified oxygen delivery system that provides high flow oxygen through nasal prongs. In this study, it is used throughout the ECT procedure to maintain oxygenation in obese patients without the need for invasive airway insertion. | Device | Alternating LMA and HFNC Oxygen Therapy |
Primary outcome
Incidence of hypoxia (SpO₂ <92%) during ECT
Time frame: During each ECT session (approximately 10-15 minutes)
11 secondary outcomes
incidence of hypoxia during recovery
Time frame: During post-anesthesia recovery (approximately 30-40 minutes)
Lowest peripheral oxygen saturation
Time frame: From preoxygenation to recovery room discharge (approximately 1 hours)
Duration of hypoxia during ECT and recovery
Time frame: From preoxygenation to recovery room discharge (approximately 1 hours)
Lowest end-tidal CO₂ before ECT stimulation
Time frame: Baseline (immediately prior to ECT stimulation)
Percent (%) increase in heart rate after ECT stimulation
Time frame: During each ECT session (approximately 10-15 minutes)
Duration of seizure (motor and EEG)
Time frame: During each ECT session (approximately 10-15 minutes)
Postictal Suppression Index (PSI)
Time frame: During each ECT session (approximately 10-15 minutes)
Husain EEG Seizure Quality Scale
Time frame: During each ECT session (approximately 10-15 minutes)
Airway management failure rate (LMA reinsertion or intubation required)
Time frame: During each ECT session (approximately 10-15 minutes)
Number of participants with dental discomfort or tooth injury within 24 hours after ECT
Time frame: Within 24 hours after each ECT session
Number of participants requiring additional oxygen support during ECT
Time frame: During each ECT session (approximately 10-15 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Mask Airway and High-Flow Nasal Cannula in people with Electroconvulsive Therapy Treated Patients and Obesity, run by Eulji University Hospital.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxia (SpO₂ <92%) during ECT (time frame: During each ECT session (approximately 10-15 minutes)). 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 30 Jul 2025.