Surgical Complications From General AnesthesiaNCT01435239
The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Pediatric Patients
A study testing The cuff inflation by the resting volume and The cuff inflation by the maximum volume in people with Surgical Complications From General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in children. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial… Read more about this study
- Who is it for?
- Ages Up to 9 years
- Conditions the study is for
- Surgical Complications From General Anesthesia
- What is being tested?
- The cuff inflation by the resting volume and The cuff inflation by the maximum volume
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Jun 2012
- 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 Up to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children (0-9 years of age)
- children who is scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using LMA-classic
Who cannot join
- patients with an abnormal airway
- patients with reactive airway disease
- patients with gastroesophageal reflux disease
- patients with chronic respiratory disease
- patients who has a history of an upper respiratory tract infection in the preceding 6-week period
Trial locations and contacts
1 site in 1 country.
About this study
Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in children. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.
- Being tested
- The cuff inflation by the resting volume, The cuff inflation by the maximum volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cuff inflation by the resting volumeDevice
80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.
The cuff inflation by the maximum volumeDevice
80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.
| Study group | Role | What they receive |
|---|---|---|
| resting volume group | Experimental | Not described Receives: Device: The cuff inflation by the resting volume |
| maximum volume group | Active comparator | Not described Receives: Device: The cuff inflation by the maximum volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intra-cuff pressure
- After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.
Measured: approximately 5 to 10 minutes after insertion of LMA.
The leak volume
- After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.
Measured: approximately 5 to 10 minutes after insertion of LMA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Complications From General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Rim LEE, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435239
- Sponsor's protocol ID
- 1-2011-0046
- Status last verified
- Mar 2014
- First submitted
- 14 Sep 2011
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wallace CJ, Chambers NA, Erb TO, von Ungern-Sternberg BS. Pressure volume curves of paediatric laryngeal mask airways. Anaesthesia. 2009 May;64(5):527-31. doi: 10.1111/j.1365-2044.2008.05819.x.
PubMed 19413823
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01435239
- Acronym / sponsor ID
- 1-2011-0046
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Sep 2011 (estimated)
- 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.
Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in children. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resting volume group | Experimental | Device: The cuff inflation by the resting volume |
| maximum volume group | Active comparator | Device: The cuff inflation by the maximum volume |
Who may qualify
- Ages
- Up to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children (0-9 years of age)
- children who is scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using LMA-classic
Key exclusion criteria (5 listed)
- patients with an abnormal airway
- patients with reactive airway disease
- patients with gastroesophageal reflux disease
- patients with chronic respiratory disease
- patients who has a history of an upper respiratory tract infection in the preceding 6-week period
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 |
|---|---|---|
| The cuff inflation by the resting volume80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume. | Device | resting volume group |
| The cuff inflation by the maximum volume80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume. | Device | maximum volume group |
Primary outcome
The intra-cuff pressure
Time frame: approximately 5 to 10 minutes after insertion of LMA.
1) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.
The leak volume
Time frame: approximately 5 to 10 minutes after insertion of LMA.
1) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Background: PubMed 19413823Wallace CJ, Chambers NA, Erb TO, von Ungern-Sternberg BS. Pressure volume curves of paediatric laryngeal mask airways. Anaesthesia. 2009 May;64(5):527-31. doi: 10.1111/j.1365-2044.2008.05819.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The cuff inflation by the resting volume and The cuff inflation by the maximum volume in people with Surgical Complications From General Anesthesia, run by Yonsei University 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 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: finished, as of the sponsor's last update on 6 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The intra-cuff pressure (time frame: approximately 5 to 10 minutes after insertion of LMA.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435239, which also lists 1 linked publication.
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 6 Mar 2014.