Evaluation of Success RateNCT01625858
Evaluation of Supraglottic Airway Devices in Children and Comparison to Historic Control
An observational study of Evaluation of Success Rate and Airway Leak Pressure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The supraglottic airway device LMA Supreme has recently been introduced for pediatric patients. The investigators will prospectively evaluate success rate and airway leak pressure in everyday's clinical pediatric anesthesia practice. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Success Rate, Airway Leak Pressure, Side Effects of LMA Supreme in Pediatric Patients Undergoing General Anesthesia
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2012to Aug 2014
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients of both genders, ages 0-18 years, ASA physical status I-III, scheduled at the University Hospital of Bern for elective surgery under general anesthesia in supine position with planned operation time <4 hours and planned airway management including a supraglottic airway.
Who may be able to join
- Patients of both genders, ages 0-18 years, ASA physical status I-III, scheduled at the University Hospital of Bern for elective surgery under general anesthesia in supine position with planned operation time <4 hours and planned airway management including a supraglottic airway, written informed consent.
Who cannot join
- Exclusion criteria are high risk of aspiration of gastric content into the lungs, body mass index >35kg/m2, cervical spine disease, known difficult airway, upper respiratory tract symptoms in the previous 10 days, preoperative sore throat, poor dentition with high risk of damage, patients not speaking German or refusing to participate.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Inselspital
Bern, Canton of Bern, 3010
About this study
Official title: Prospective Evaluation of Pediatric Supraglottic Airways in Anesthetized Children
The supraglottic airway device LMA Supreme has recently been introduced for pediatric patients. The investigators will prospectively evaluate success rate and airway leak pressure in everyday's clinical pediatric anesthesia practice. Primary hypothesis is that the LMA Supreme has a leak pressure with a 95% confidence interval of 18-22cmH2O. Leak pressures will be compared to results from other pediatric supraglottic airway devices previously studied by the investigators group. Secondary Hypothesis: The primary success rate of the LMA-S is higher than 90%; therefore, performance is similar to the performance of the Ambu Aura Once™ and of the i-gel™. Study design: Prospective controlled observational cohort study.
In a second step, we will include more pediatric supraglottic airway devices. Each new arm will be handled exactly the same, assuming the same hypothesis being justified.
Read the detailed description
The induction of anesthesia will follow the standard operating procedures of the pediatric anesthesia division at the children's hospital for the use of supraglottic airway devices. After loss of eyelash reflex and proper bag-mask ventilation provided, the SGA will be introduced into the mouth under standardized anesthesia to guarantee the same depth of anesthesia. This includes either propofol 2.5 mg/kg for older children, or sevoflurane inhalation in younger children at an end-tidal sevoflurane concentration of 6%. The time necessary to insert the airway device and the success rate will be recorded. We will also check at what airway pressure the SGA starts leaking. A fiberscope will be inserted through the airway port and through the gastric tube to obtain a view of the vocal cords and evaluate the position of the SGA. The gastric catheter will then be placed after insertion; the size will be according manufacturers' recommendations. After surgery, the SGA will be checked for evidence of mucosa lesions (blood stains on device). One day after surgery, the patient (and/or the parents) will be interviewed about sore throat, hoarseness, dysphagia, postoperative nausea and vomiting (PONV), rescue medication, pain, time of hospital discharge and any unscheduled re-hospitalization.
Before and during the operation, the following data will be recorded: Sex, age, weight, surgical procedure and duration, medications needed, cardiovascular parameter, depth of anesthesia. Secondary outcome data include:
- The insertion time necessary to airway device placement.
- Success rate of SGA device to ventilate patient
- Fiberscope view through the airway port on the glottis opening (1 full vision on the vocal cords - 4 no structure distinguishable)
- Fiberscope view through the airway gastric tube channel on the upper esophageal sphincter (rating 1-4)
- Placement of the gastric catheter (yes, no)
- Postoperative: Device will be checked for evidence of mucosa lesions (blood stains on device).
- Conditions
- Evaluation of Success Rate, Airway Leak Pressure, Side Effects of LMA Supreme in Pediatric Patients Undergoing General Anesthesia
- Keywords
- LMA Supreme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Supreme / other pediatric SGA | pediatric patients undergoing general anesthesia being treated with LMA Supreme or another pediatric supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway leak pressure
Measured in cmH2O
Measured: After 8 months
Secondary outcomes (1)
Number of LMA-S with primary success
Measured: After 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2014
- Study completionAug 2014
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 Evaluation of Success RateStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Greif, MD MME, Study chair, University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625858
- Sponsor's protocol ID
- THLD-4-12
- Status last verified
- Sep 2014
- First submitted
- 31 May 2012
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kleine-Brueggeney M, Gottfried A, Nabecker S, Greif R, Book M, Theiler L. Pediatric supraglottic airway devices in clinical practice: A prospective observational study. BMC Anesthesiol. 2017 Sep 2;17(1):119. doi: 10.1186/s12871-017-0403-6.
PubMed 28865448
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Pediatric Supraglottic Airways in Anesthetized Children
- ClinicalTrials.gov ID
- NCT01625858
- Acronym / sponsor ID
- THLD-4-12
- Conditions
- Evaluation of Success Rate, Airway Leak Pressure, Side Effects of LMA Supreme in Pediatric Patients Undergoing General Anesthesia
- Keywords
- LMA Supreme
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Jun 2012 (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 supraglottic airway device LMA Supreme has recently been introduced for pediatric patients. The investigators will prospectively evaluate success rate and airway leak pressure in everyday's clinical pediatric anesthesia practice. Primary hypothesis is that the LMA Supreme has a leak pressure with a 95% confidence interval of 18-22cmH2O. Leak pressures will be compared to results from other pediatric supraglottic airway devices previously studied by the investigators group. Secondary Hypothesis: The primary success rate of the LMA-S is higher than 90%; therefore, performance is similar to the performance of the Ambu Aura Once™ and of the i-gel™. Study design: Prospective controlled observational cohort study.
In a second step, we will include more pediatric supraglottic airway devices. Each new arm will be handled exactly the same, assuming the same hypothesis being justified.
Detailed description
The induction of anesthesia will follow the standard operating procedures of the pediatric anesthesia division at the children's hospital for the use of supraglottic airway devices. After loss of eyelash reflex and proper bag-mask ventilation provided, the SGA will be introduced into the mouth under standardized anesthesia to guarantee the same depth of anesthesia. This includes either propofol 2.5 mg/kg for older children, or sevoflurane inhalation in younger children at an end-tidal sevoflurane concentration of 6%. The time necessary to insert the airway device and the success rate will be recorded. We will also check at what airway pressure the SGA starts leaking. A fiberscope will be inserted through the airway port and through the gastric tube to obtain a view of the vocal cords and evaluate the position of the SGA. The gastric catheter will then be placed after insertion; the size will be according manufacturers' recommendations. After surgery, the SGA will be checked for evidence of mucosa lesions (blood stains on device). One day after surgery, the patient (and/or the parents) will be interviewed about sore throat, hoarseness, dysphagia, postoperative nausea and vomiting (PONV), rescue medication, pain, time of hospital discharge and any unscheduled re-hospitalization.
Before and during the operation, the following data will be recorded: Sex, age, weight, surgical procedure and duration, medications needed, cardiovascular parameter, depth of anesthesia. Secondary outcome data include:
- The insertion time necessary to airway device placement.
- Success rate of SGA device to ventilate patient
- Fiberscope view through the airway port on the glottis opening (1 full vision on the vocal cords - 4 no structure distinguishable)
- Fiberscope view through the airway gastric tube channel on the upper esophageal sphincter (rating 1-4)
- Placement of the gastric catheter (yes, no)
- Postoperative: Device will be checked for evidence of mucosa lesions (blood stains on device).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supreme / other pediatric SGA | – | –pediatric patients undergoing general anesthesia being treated with LMA Supreme or another pediatric supraglottic airway device |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients of both genders, ages 0-18 years, ASA physical status I-III, scheduled at the University Hospital of Bern for elective surgery under general anesthesia in supine position with planned operation time <4 hours and planned airway management including a supraglottic airway.
Key inclusion criteria (1 listed)
- Patients of both genders, ages 0-18 years, ASA physical status I-III, scheduled at the University Hospital of Bern for elective surgery under general anesthesia in supine position with planned operation time <4 hours and planned airway management including a supraglottic airway, written informed consent.
Key exclusion criteria (1 listed)
- Exclusion criteria are high risk of aspiration of gastric content into the lungs, body mass index >35kg/m2, cervical spine disease, known difficult airway, upper respiratory tract symptoms in the previous 10 days, preoperative sore throat, poor dentition with high risk of damage, patients not speaking German or refusing to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Airway leak pressure
Time frame: After 8 months
Measured in cmH2O
1 secondary outcome
Number of LMA-S with primary success
Time frame: After 8 months
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 3 Sep 2014.
- Derived from this study: PubMed 28865448Kleine-Brueggeney M, Gottfried A, Nabecker S, Greif R, Book M, Theiler L. Pediatric supraglottic airway devices in clinical practice: A prospective observational study. BMC Anesthesiol. 2017 Sep 2;17(1):119. doi: 10.1186/s12871-017-0403-6.
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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.
Robert Greif, MD MME study chair
University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
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 Evaluation of Success Rate and Airway Leak Pressure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 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 3 Sep 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 Switzerland. 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?
Airway leak pressure (time frame: After 8 months). 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 NCT01625858, 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 3 Sep 2014.