Body WeightNCT03528590
Ventilation Efficacy of Size 3 or Size 4 I-gel in Female Patient Weighing 50 to 60 Kilograms
A study testing size 3 i-gel supraglottic airway device and size 4 i-gel supraglottic airway device in people with Body Weight and Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Currently, the main method for selecting an i-gel® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Body Weight, Breast Neoplasms, Laryngeal Masks
- What is being tested?
- size 3 i-gel supraglottic airway device and size 4 i-gel supraglottic airway device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 May 2018to May 2019
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20 years old.
- ASA physical status I and II.
- Elective breast surgery.
- Female with a body weight of 50 - 60 kilograms.
Who cannot join
- High risk of aspiration. (defined as history of gastroesophageal reflux, hiatal hernia, previous gastric surgery, and those who take medications for disorders of gastrointestinal motility)
- Previous head \& neck surgery.
- Previous head \& neck concurrent chemoradiotherapy (CCRT)
- Reactive airway disease: chronic obstructive pulmonary disease (COPD), asthma, upper respiratory infection in recent two weeks
- Exposure to tobacco
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
TSUNG AN TSAI, MD, 886-886-2-23123456 ext. 62158, na0822@hotmail.com
Ming Hui Hung, MD, 886-2-23123456 ext. 62158, hung.minghui@gmail.com
About this study
Official title: Ventilation Efficacy of I-gel® Size 3 and Size 4 Supraglottic Airway Devices in Anesthetized, Paralyzed Female Patients Weighing Between 50 and 60 Kilograms: a Randomized Trial
Currently, the main method for selecting an i-gel® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gel® in this cohort.
Read the detailed description
With the introduction of the laryngeal mask, it has been widely used for the management of airway during general anesthesia. Compared to the endotracheal tube, it has the advantages of easier and faster placing, reducing the proportion of a sore throat and other benefits. The i-gel® is a second-generation of the laryngeal mask. Compared to the classic laryngeal mask, it provides higher sealing pressure and better airway protection to reduce respiratory complications.
Choosing an appropriate size laryngeal mask is an important issue. Trauma during placing or positive ventilation failure may occur if the wrong size is selected. Currently, the main method for selecting an i-gel® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gel® in this cohort.
Keywords: Airway management; laryngeal mask airway; breast surgery
- Conditions
- Body Weight, Breast Neoplasms, Laryngeal Masks
- Being tested
- size 3 i-gel supraglottic airway device, size 4 i-gel supraglottic airway device
- Keywords
- laryngeal mask airway, breast surgery
- Medical subject headings
- Body Weight, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
size 3 i-gel supraglottic airway deviceDevice
Use size 3 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
size 4 i-gel supraglottic airway deviceDevice
Use size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
| Study group | Role | What they receive |
|---|---|---|
| size 3 i-gel® | Active comparator | size 3 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Receives: Device: size 3 i-gel supraglottic airway device |
| size 4 i-gel® | Experimental | size 4 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Receives: Device: size 4 i-gel supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Use ventilation score (1 point for presence of each item, a total score from 0 to 3) to evaluate ventilation efficacy. Ventilation score include:
- Air leak pressure below 15 cm H2O
- Bilateral chest excursion during inspiratory 20 cm H2O
- Square wave capnography
Measured: 1 day
Secondary outcomes (1)
Compare side effects of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Any Side effects include:
- Blood stain on i-gel after removing
- Sore throat at post-anaesthesia care unit (PACU)
- Sore throat after 24 hours
- Dysphagia after 24 hours
- Mouth, lip and tongue injury
- Dysphonia
- Hiccup
- Myalgia
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start28 May 2018
- Primary completionMar 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Hui Hung, MD, Principal investigator, National Taiwan University Hospital Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528590
- Sponsor's protocol ID
- 201803061RIND
- Status last verified
- Apr 2018
- First submitted
- 7 May 2018
- Last updated
- 30 May 2018
- Results posted
- 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 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation Efficacy of I-gel® Size 3 and Size 4 Supraglottic Airway Devices in Anesthetized, Paralyzed Female Patients Weighing Between 50 and 60 Kilograms: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03528590
- Acronym / sponsor ID
- 201803061RIND
- Conditions
- Body Weight, Breast Neoplasms, Laryngeal Masks
- Keywords
- laryngeal mask airway, breast surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 18 May 2018 (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.
Currently, the main method for selecting an i-gel® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gel® in this cohort.
Detailed description
With the introduction of the laryngeal mask, it has been widely used for the management of airway during general anesthesia. Compared to the endotracheal tube, it has the advantages of easier and faster placing, reducing the proportion of a sore throat and other benefits. The i-gel® is a second-generation of the laryngeal mask. Compared to the classic laryngeal mask, it provides higher sealing pressure and better airway protection to reduce respiratory complications.
Choosing an appropriate size laryngeal mask is an important issue. Trauma during placing or positive ventilation failure may occur if the wrong size is selected. Currently, the main method for selecting an i-gel® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gel® in this cohort.
Keywords: Airway management; laryngeal mask airway; breast surgery
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| size 3 i-gel® | Active comparator | Device: size 3 i-gel supraglottic airway devicesize 3 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. |
| size 4 i-gel® | Experimental | Device: size 4 i-gel supraglottic airway devicesize 4 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 20 years old.
- ASA physical status I and II.
- Elective breast surgery.
- Female with a body weight of 50 - 60 kilograms.
Key exclusion criteria (6 listed)
- High risk of aspiration. (defined as history of gastroesophageal reflux, hiatal hernia, previous gastric surgery, and those who take medications for disorders of gastrointestinal motility)
- Previous head \& neck surgery.
- Previous head \& neck concurrent chemoradiotherapy (CCRT)
- Reactive airway disease: chronic obstructive pulmonary disease (COPD), asthma, upper respiratory infection in recent two weeks
- Exposure to tobacco
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 |
|---|---|---|
| size 3 i-gel supraglottic airway deviceUse size 3 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. | Device | size 3 i-gel® |
| size 4 i-gel supraglottic airway deviceUse size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. | Device | size 4 i-gel® |
Primary outcome
Compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Time frame: 1 day
Use ventilation score (1 point for presence of each item, a total score from 0 to 3) to evaluate ventilation efficacy. Ventilation score include: 1. Air leak pressure below 15 cm H2O 2. Bilateral chest excursion during inspiratory 20 cm H2O 3. Square wave capnography
1 secondary outcome
Compare side effects of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- 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.
Ming Hui Hung, MD principal investigator
National Taiwan University Hospital Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing size 3 i-gel supraglottic airway device and size 4 i-gel supraglottic airway device in people with Body Weight and Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 6 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 30 May 2018. 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 Taiwan. 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 TSUNG AN TSAI, MD (886-2-23123456 ext. 62158, na0822@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. (time frame: 1 day). 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 May 2018.