Size of Laryngeal Mask AirwayNCT02732613
Selection of Laryngeal Mask Airway in Patients With Slender Somatotype
A study testing Laryngeal Mask Airway in people with Size of Laryngeal Mask Airway and Body Weight, run by XiQiang Huang.
Trial summary
The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's recommendation based on the patient's ideal weight. But sometimes the patient is tall and slim, the actual weight is much less than the ideal weight. This phenomenon might affect the success rate of insertion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Size of Laryngeal Mask Airway, Body Weight, Success Rate of First Attempt
- What is being tested?
- Laryngeal Mask Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Nov 2016
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult Patients undergo elective surgery of American Society of Anesthesiologists (ASA) physical status 1-2, aged from 18 to 60;
- Patients' actual weight much less than ideal weight.
Who cannot join
- Patients with gastroesophageal reflux disease;
- Patients with predicted difficult airway;
- Patients with preexisting airway diseases or significant upper airway infection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Selection of Laryngeal Mask Airway When Actual Body Weight Much Less Than Ideal Body Weight in Adult Patients
The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's recommendation based on the patient's ideal weight. But sometimes the patient is tall and slim, the actual weight is much less than the ideal weight. This phenomenon might affect the success rate of insertion. Previous studies had demonstrated that the selection of Laryngeal Mask Airway size based on ideal weight could improve the success rate of insertion; therefore, this study was designed to prove whether this conclusion also applies to the tall and thin patients.
Read the detailed description
One hundred and eighteen patients adult patients，actual body weight much less than ideal body weight will be assigned randomly to two groups (Actual weight Group or Ideal weight Group). Size selection was guided by the recommendations of manufacturer, patients will be based on the actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.
The success rate of first attempt，number of adjustments, insertion time, ease of insertion, overall success rate, oropharyngeal leak pressure and fiberoptic view will be recorded and compared. The occurrences of respiratory complications such as sore throat, hoarseness, and dysphonia will be observed and recorded.
- Being tested
- Laryngeal Mask Airway
- Keywords
- Laryngeal Mask Airway, Body weight, Complication
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask AirwayDevice
If there were any conflicts of the Laryngeal Mask Airway classic size selection in slim patients by the actual or ideal body weight, size selection will based on actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.
| Study group | Role | What they receive |
|---|---|---|
| Actual weight Group | Experimental | Patients in Actual weight Group: The selection of Laryngeal Mask Airway classic will be based on actual body weight, followed the recommendations of manufacturer (size 3 for weight < 50 kg, size 4 for weight 50-70 kg, and size 5 for weight > 70 kg ). Receives: Device: Laryngeal Mask Airway |
| Ideal weight Group | Experimental | Patients in Ideal weight Group: The selection of Laryngeal Mask Airway classic will be based on ideal body weight, followed the recommendations of manufacturer ( size 3 for weight < 50 kg, size 4 for weight 50-70 kg, and size 5 for weight > 70 kg ). Receives: Device: Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of Laryngeal Mask Airway first insertion
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Size of Laryngeal Mask AirwayStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XiQiang Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor-investigator, XiQiang Huang, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732613
- Sponsor's protocol ID
- ZSPH20160303
- Status last verified
- Apr 2016
- First submitted
- 28 Mar 2016
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection of Laryngeal Mask Airway When Actual Body Weight Much Less Than Ideal Body Weight in Adult Patients
- ClinicalTrials.gov ID
- NCT02732613
- Acronym / sponsor ID
- ZSPH20160303
- Keywords
- Laryngeal Mask Airway, Body weight, Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- XiQiang HuangUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 8 Apr 2016 (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.
The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's recommendation based on the patient's ideal weight. But sometimes the patient is tall and slim, the actual weight is much less than the ideal weight. This phenomenon might affect the success rate of insertion. Previous studies had demonstrated that the selection of Laryngeal Mask Airway size based on ideal weight could improve the success rate of insertion; therefore, this study was designed to prove whether this conclusion also applies to the tall and thin patients.
Detailed description
One hundred and eighteen patients adult patients，actual body weight much less than ideal body weight will be assigned randomly to two groups (Actual weight Group or Ideal weight Group). Size selection was guided by the recommendations of manufacturer, patients will be based on the actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.
The success rate of first attempt，number of adjustments, insertion time, ease of insertion, overall success rate, oropharyngeal leak pressure and fiberoptic view will be recorded and compared. The occurrences of respiratory complications such as sore throat, hoarseness, and dysphonia will be observed and recorded.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actual weight Group | Experimental | Device: Laryngeal Mask AirwayPatients in Actual weight Group: The selection of Laryngeal Mask Airway classic will be based on actual body weight, followed the recommendations of manufacturer (size 3 for weight < 50 kg, size 4 for weight 50-70 kg, and size 5 for weight > 70 kg ). |
| Ideal weight Group | Experimental | Device: Laryngeal Mask AirwayPatients in Ideal weight Group: The selection of Laryngeal Mask Airway classic will be based on ideal body weight, followed the recommendations of manufacturer ( size 3 for weight < 50 kg, size 4 for weight 50-70 kg, and size 5 for weight > 70 kg ). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult Patients undergo elective surgery of American Society of Anesthesiologists (ASA) physical status 1-2, aged from 18 to 60;
- Patients' actual weight much less than ideal weight.
Key exclusion criteria (3 listed)
- Patients with gastroesophageal reflux disease;
- Patients with predicted difficult airway;
- Patients with preexisting airway diseases or significant upper airway infection.
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 AirwayIf there were any conflicts of the Laryngeal Mask Airway classic size selection in slim patients by the actual or ideal body weight, size selection will based on actual body weight in Actual weight Group while ideal body weight in Ideal weight Group. | Device | Actual weight Group, Ideal weight Group |
Primary outcome
The success rate of Laryngeal Mask Airway first insertion
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Mask Airway in people with Size of Laryngeal Mask Airway and Body Weight, run by XiQiang Huang.
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 3 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 8 Apr 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiqiang Huang, Bachelor (+86-18923324188, 75303811@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of Laryngeal Mask Airway first insertion (time frame: Six months). 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 8 Apr 2016.