TonsillitisNCT00570414
Airway Management in Children Undergoing Adenotonsillectomies
A study testing Laryngeal mask airway and Endotracheal tube in people with Tonsillitis, run by Sykehuset Telemark at 1 site in Norway.
Trial summary
Secure airway management is the basis of all anesthesiological practice. Of particular importance is the securing of patients' airway passages when the surgical procedure itself poses a threat to a patient's airway, as is the case in all procedures involving the upper respiratory pathways. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Tonsillitis
- What is being tested?
- Laryngeal mask airway and Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2007to Aug 2008
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 10-60 kg
- Elective adenotomy, tonsillectomy or combined adenotonsillectomy under general anesthesia.
- Written and oral informed parental consent.
Who cannot join
- ASA III or higher.
- Weight < 10 kg or weight > 60 kg.
- Congenital malformations of the mouth or throat.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Sykehuset Telemark, Clinic of emergency medicin
Porsgrunn, Telemark, 3913
About this study
Official title: Airway Management in Children Undergoing Adenotonsillectomies Under General Anesthesia; a Comparison of the Endotracheal Tube and the Laryngeal Mask Airway
Secure airway management is the basis of all anesthesiological practice. Of particular importance is the securing of patients' airway passages when the surgical procedure itself poses a threat to a patient's airway, as is the case in all procedures involving the upper respiratory pathways. When adenoidectomies, tonsillectomies and combined adenotonsillectomies are performed, blood from the surgical area will present a respiratory threat to unsecured airways. The traditional opinion has been that endotracheal intubation is the safest method of preventing aspiration.
The laryngeal mask was introduced in 1983 as an alternative to the endotracheal tube. In 1990, the flexible, reinforced laryngeal mask airway was introduced, intended for use during surgical procedures involving the mouth and throat. The laryngeal mask airway has several potential advantages over the endotracheal tube. It is inserted blindly, without laryngoscopy. This leads to reduced oropharyngeal or laryngeal stimulation and injury, and therefore minimal activation of respiratory and circulatory reflexes. The laryngeal mask airway can be placed without the use of muscle relaxants, avoiding potential side effects such as apnea, hyperkalemia and anaphylaxis. In addition the laryngeal mask airway can remain in the throat until the patient awakes, virtually eliminating the danger of postoperative aspiration.
Read more
Several international studies have described the advantages of the laryngeal mask airway over endotracheal intubation during ear, nose and throat surgery in children. The general impression is that there is a widespread routine implementation of the laryngeal mask airway. In Norway, however, this practice has been limited. As far as we know, only Namsos Hospital uses this procedure as its first choice. At Telemark Hospital we tested the use of laryngeal mask airway on 150 patients between May and December 2006. The results so far have been promising, and we have had no serious complications.
Hypothesis:
In children undergoing adenotonsillectomies, a laryngeal mask airway provides greater patient satisfaction (judged by reduced pain, nausea and vomiting) and greater effectivity (judged by reduced time in surgery), compared with the endotracheal tube. The laryngeal mask provides as much as or greater secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs.
Read the detailed description
Registration:
Preoperative: Age, height, weight, medication, asthma/allergy, possible current respiratory infection
Peroperative: Type of procedure, tube size/laryngeal mask, type of tongue blade, highest/lowest SpO2, highest/lowest ET CO2, highest/lowest pulse, length of surgery, total operating room time, operator, medication. Reason must be given if converting from laryngeal mask to tube; lack of visibility for operator, laryngeal mask not possible to place, unacceptable leakage before placing tongue blade, occlusion after placement of tongue blade.
Postoperative: Pain judged by need for opiates (VAS, crying, agitation, tachycardia), nausea judged by gagging/vomiting, total time in recovery, rebleeding judged by reoperation.
Anesthesia:
Induction: Alfentanil 20 microg/kg body weight Propofol 3-4 mg/kg body weight Or: Sevoflurane/N2O mask induction with MAC 1-2
Maintenance: Alfentanil 5-10 microg/kg body weight every 8-10 minutes Sevoflurane/N2O equivalent to 1-1.5 MAC Acetaminophen supp 40 mg/kg body weight, max 2 g. Dexamethasone 0.15mg/kg body weight Xylocaine 1mg/kg body weight
Emergence: Morphine 100-200 mikrog/kg body weight
Postoperative: Morphine 50-100 microg/kg body weight
Post-discharge: Acetaminophen tbl 15 mg/kg body weight x 3 Or: Acetaminophen supp 20 mg/kg body weight x 3
Patient booklet:
A patient booklet will be produced for each patient. The booklet will contain only the patient's initials, age and research number. After the booklets are filled out, they will be stored in a locked facility by one of the examining physicians, and the code to the patient's name will be stored and locked separately by one of the researchers. The code will be destroyed at the end of the research study.
- Conditions
- Tonsillitis
- Being tested
- Laryngeal mask airway, Endotracheal tube
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask airwayDevice
Airway management by the use of the flexible, reinforced laryngeal mask airway
Endotracheal tubeDevice
Airway management by the use of endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Laryngeal mask airway (LMA) Receives: Device: Laryngeal mask airway |
| 2 | Active comparator | Endotracheal tube (ETT) Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction: a) Pain (VAS, use of opioids), b) Nausea and vomiting (score)
Measured: 24 hrs
Secondary outcomes (2)
Effectivity (judged by reduced time in surgery)
Measured: 1 hrs
Secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs.
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Investigators
- Simen Doksrød, MD, Principal investigator, Sykehuset TelemarkPeter Heidt, PhD, Study director, Namsos Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570414
- Sponsor's protocol ID
- s8197.03
- Other IDs
- s-07031b
- Status last verified
- Jan 2009
- First submitted
- 10 Dec 2007
- Last updated
- 15 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management in Children Undergoing Adenotonsillectomies Under General Anesthesia; a Comparison of the Endotracheal Tube and the Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT00570414
- Acronym / sponsor ID
- s8197.03
- Conditions
- Tonsillitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Sykehuset TelemarkOther government
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 11 Dec 2007 (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.
Secure airway management is the basis of all anesthesiological practice. Of particular importance is the securing of patients' airway passages when the surgical procedure itself poses a threat to a patient's airway, as is the case in all procedures involving the upper respiratory pathways. When adenoidectomies, tonsillectomies and combined adenotonsillectomies are performed, blood from the surgical area will present a respiratory threat to unsecured airways. The traditional opinion has been that endotracheal intubation is the safest method of preventing aspiration.
The laryngeal mask was introduced in 1983 as an alternative to the endotracheal tube. In 1990, the flexible, reinforced laryngeal mask airway was introduced, intended for use during surgical procedures involving the mouth and throat. The laryngeal mask airway has several potential advantages over the endotracheal tube. It is inserted blindly, without laryngoscopy. This leads to reduced oropharyngeal or laryngeal stimulation and injury, and therefore minimal activation of respiratory and circulatory reflexes. The laryngeal mask airway can be placed without the use of muscle relaxants, avoiding potential side effects such as apnea, hyperkalemia and anaphylaxis. In addition the laryngeal mask airway can remain in the throat until the patient awakes, virtually eliminating the danger of postoperative aspiration.
Several international studies have described the advantages of the laryngeal mask airway over endotracheal intubation during ear, nose and throat surgery in children. The general impression is that there is a widespread routine implementation of the laryngeal mask airway. In Norway, however, this practice has been limited. As far as we know, only Namsos Hospital uses this procedure as its first choice. At Telemark Hospital we tested the use of laryngeal mask airway on 150 patients between May and December 2006. The results so far have been promising, and we have had no serious complications.
Hypothesis:
In children undergoing adenotonsillectomies, a laryngeal mask airway provides greater patient satisfaction (judged by reduced pain, nausea and vomiting) and greater effectivity (judged by reduced time in surgery), compared with the endotracheal tube. The laryngeal mask provides as much as or greater secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs.
Detailed description
Registration:
Preoperative: Age, height, weight, medication, asthma/allergy, possible current respiratory infection
Peroperative: Type of procedure, tube size/laryngeal mask, type of tongue blade, highest/lowest SpO2, highest/lowest ET CO2, highest/lowest pulse, length of surgery, total operating room time, operator, medication. Reason must be given if converting from laryngeal mask to tube; lack of visibility for operator, laryngeal mask not possible to place, unacceptable leakage before placing tongue blade, occlusion after placement of tongue blade.
Postoperative: Pain judged by need for opiates (VAS, crying, agitation, tachycardia), nausea judged by gagging/vomiting, total time in recovery, rebleeding judged by reoperation.
Anesthesia:
Induction: Alfentanil 20 microg/kg body weight Propofol 3-4 mg/kg body weight Or: Sevoflurane/N2O mask induction with MAC 1-2
Maintenance: Alfentanil 5-10 microg/kg body weight every 8-10 minutes Sevoflurane/N2O equivalent to 1-1.5 MAC Acetaminophen supp 40 mg/kg body weight, max 2 g. Dexamethasone 0.15mg/kg body weight Xylocaine 1mg/kg body weight
Emergence: Morphine 100-200 mikrog/kg body weight
Postoperative: Morphine 50-100 microg/kg body weight
Post-discharge: Acetaminophen tbl 15 mg/kg body weight x 3 Or: Acetaminophen supp 20 mg/kg body weight x 3
Patient booklet:
A patient booklet will be produced for each patient. The booklet will contain only the patient's initials, age and research number. After the booklets are filled out, they will be stored in a locked facility by one of the examining physicians, and the code to the patient's name will be stored and locked separately by one of the researchers. The code will be destroyed at the end of the research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Laryngeal mask airwayLaryngeal mask airway (LMA) |
| 2 | Active comparator | Device: Endotracheal tubeEndotracheal tube (ETT) |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 10-60 kg
- Elective adenotomy, tonsillectomy or combined adenotonsillectomy under general anesthesia.
- Written and oral informed parental consent.
Key exclusion criteria (3 listed)
- ASA III or higher.
- Weight < 10 kg or weight > 60 kg.
- Congenital malformations of the mouth or throat.
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 airwayAirway management by the use of the flexible, reinforced laryngeal mask airway | Device | 1 |
| Endotracheal tubeAirway management by the use of endotracheal tube | Device | 2 |
Primary outcome
Patient satisfaction: a) Pain (VAS, use of opioids), b) Nausea and vomiting (score)
Time frame: 24 hrs
2 secondary outcomes
Effectivity (judged by reduced time in surgery)
Time frame: 1 hrs
Secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs.
Time frame: 24 hrs
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 15 Jan 2009.
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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.
Simen Doksrød, MD principal investigator
Sykehuset Telemark
Peter Heidt, PhD study director
Namsos Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask airway and Endotracheal tube in people with Tonsillitis, run by Sykehuset Telemark at 1 site in Norway.
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 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: finished, as of the sponsor's last update on 15 Jan 2009. 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 Norway. 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?
Patient satisfaction: a) Pain (VAS, use of opioids), b) Nausea and vomiting (score) (time frame: 24 hrs). 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 15 Jan 2009.