General AnaesthesiaNCT04215302
Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient
An observational study of General Anaesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
the study aimed to know the accuracy for laryngeal mask unique TM size to Malay pediatric race according to weight measurement recommended by manufacturer Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- General Anaesthesia
- What is being tested?
- laryngeal mask
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Sep 2019to 5 Nov 2019
- Phase
- Observational
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric population aged 1 - 10 years old underwent general anesthesia procedure with laryngeal mask airway device
Who may be able to join
- aged 1 -10 years old
- Malay race
- scheduled for general anesthesia procedure with laryngeal mask
Who cannot join
- disagree to be included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction Accuracy for Langeal Mask Unique TM Size in Melayu Pediatric Population According to Weight Meissurement
the study aimed to know the accuracy for laryngeal mask unique TM size to Malay pediatric race according to weight measurement recommended by manufacturer
Read the detailed description
sixty-six pediatric subjects aged between 1 - 10 years old underwent general anesthesia using laryngeal mask Unique TM. Laryngeal mask inserted using the size based on subject's weight. Effectivity was confirmed if there is no air sound from patient's mouth, airway seal pressure ≥20 cmH2O, maximum inspiration pressure was ≤ 20 cmH2O, difference in expiration and inspiration tidal volume less than 5%, and there is no cuff appear in mouth.
- Conditions
- General Anaesthesia
- Being tested
- laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal maskDevice
the size of laryngeal mask given to the patient was based on patient's weight measurement
| Study group | Role | What they receive |
|---|---|---|
| laryngeal mask size | laryngeal mask size determines according to weight measurement Receives: Device: laryngeal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful insertion of laryngeal mask
observe the sign of successful insertion of laryngeal mask
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start17 Sep 2019
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for General AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Kapuangan, Universitas Indonesia
- Investigators
- Christopher Kapuangan, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215302
- Sponsor's protocol ID
- IndonesiaUAnes053
- Status last verified
- Dec 2019
- First submitted
- 30 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michalek P, Donaldson W, Vobrubova E, Hakl M. Complications Associated with the Use of Supraglottic Airway Devices in Perioperative Medicine. Biomed Res Int. 2015;2015:746560. doi: 10.1155/2015/746560. Epub 2015 Dec 13.
PubMed 26783527Takahoko K, Iwasaki H, Sasakawa T, Suzuki A, Matsumoto H, Iwasaki H. Unilateral hypoglossal nerve palsy after use of the laryngeal mask airway supreme. Case Rep Anesthesiol. 2014;2014:369563. doi: 10.1155/2014/369563. Epub 2014 Aug 31.
PubMed 25254120Brain AI, Howard D. Lingual nerve injury associated with laryngeal mask use. Anaesthesia. 1998 Jul;53(7):713-4. doi: 10.1046/j.1365-2044.1998.537d-az0584d.x. No abstract available.
PubMed 9771185King C, Street MK. Twelfth cranial nerve paralysis following use of a laryngeal mask airway. Anaesthesia. 1994 Sep;49(9):786-7. doi: 10.1111/j.1365-2044.1994.tb04452.x. No abstract available.
PubMed 7978135Lowinger D, Benjamin B, Gadd L. Recurrent laryngeal nerve injury caused by a laryngeal mask airway. Anaesth Intensive Care. 1999 Apr;27(2):202-5. doi: 10.1177/0310057X9902700214.
PubMed 10212721Wynn JM, Jones KL. Tongue cyanosis after laryngeal mask airway insertion. Anesthesiology. 1994 Jun;80(6):1403. No abstract available.
PubMed 8010489van Zundert TC, Brimacombe JR, Ferson DZ, Bacon DR, Wilkinson DJ. Archie Brain: celebrating 30 years of development in laryngeal mask airways. Anaesthesia. 2012 Dec;67(12):1375-85. doi: 10.1111/anae.12003.x.
PubMed 23130725
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Accuracy for Langeal Mask Unique TM Size in Melayu Pediatric Population According to Weight Meissurement
- ClinicalTrials.gov ID
- NCT04215302
- Acronym / sponsor ID
- IndonesiaUAnes053
- Conditions
- General Anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 2 Jan 2020 (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.
the study aimed to know the accuracy for laryngeal mask unique TM size to Malay pediatric race according to weight measurement recommended by manufacturer
Detailed description
sixty-six pediatric subjects aged between 1 - 10 years old underwent general anesthesia using laryngeal mask Unique TM. Laryngeal mask inserted using the size based on subject's weight. Effectivity was confirmed if there is no air sound from patient's mouth, airway seal pressure ≥20 cmH2O, maximum inspiration pressure was ≤ 20 cmH2O, difference in expiration and inspiration tidal volume less than 5%, and there is no cuff appear in mouth.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laryngeal mask size | – | Device: laryngeal masklaryngeal mask size determines according to weight measurement |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric population aged 1 - 10 years old underwent general anesthesia procedure with laryngeal mask airway device
Key inclusion criteria (3 listed)
- aged 1 -10 years old
- Malay race
- scheduled for general anesthesia procedure with laryngeal mask
Key exclusion criteria (1 listed)
- disagree to be included in the study
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 maskthe size of laryngeal mask given to the patient was based on patient's weight measurement | Device | laryngeal mask size |
Primary outcome
successful insertion of laryngeal mask
Time frame: 3 minutes
observe the sign of successful insertion of laryngeal mask
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 2 Jan 2020.
- Results publication: PubMed 26783527Michalek P, Donaldson W, Vobrubova E, Hakl M. Complications Associated with the Use of Supraglottic Airway Devices in Perioperative Medicine. Biomed Res Int. 2015;2015:746560. doi: 10.1155/2015/746560. Epub 2015 Dec 13.
- Results publication: PubMed 25254120Takahoko K, Iwasaki H, Sasakawa T, Suzuki A, Matsumoto H, Iwasaki H. Unilateral hypoglossal nerve palsy after use of the laryngeal mask airway supreme. Case Rep Anesthesiol. 2014;2014:369563. doi: 10.1155/2014/369563. Epub 2014 Aug 31.
- Results publication: PubMed 9771185Brain AI, Howard D. Lingual nerve injury associated with laryngeal mask use. Anaesthesia. 1998 Jul;53(7):713-4. doi: 10.1046/j.1365-2044.1998.537d-az0584d.x. No abstract available.
- Results publication: PubMed 7978135King C, Street MK. Twelfth cranial nerve paralysis following use of a laryngeal mask airway. Anaesthesia. 1994 Sep;49(9):786-7. doi: 10.1111/j.1365-2044.1994.tb04452.x. No abstract available.
- Results publication: PubMed 10212721Lowinger D, Benjamin B, Gadd L. Recurrent laryngeal nerve injury caused by a laryngeal mask airway. Anaesth Intensive Care. 1999 Apr;27(2):202-5. doi: 10.1177/0310057X9902700214.
- Results publication: PubMed 8010489Wynn JM, Jones KL. Tongue cyanosis after laryngeal mask airway insertion. Anesthesiology. 1994 Jun;80(6):1403. No abstract available.
- Results publication: PubMed 23130725van Zundert TC, Brimacombe JR, Ferson DZ, Bacon DR, Wilkinson DJ. Archie Brain: celebrating 30 years of development in laryngeal mask airways. Anaesthesia. 2012 Dec;67(12):1375-85. doi: 10.1111/anae.12003.x.
- 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.
Christopher Kapuangan, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anaesthesia, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 1 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 2 Jan 2020. 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 Indonesia. 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?
successful insertion of laryngeal mask (time frame: 3 minutes). 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 NCT04215302, which also lists 7 linked publications.
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 2 Jan 2020.