Anesthesia Intubation ComplicationPhase 2NCT06356298
Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy
A Phase 2 study testing Airway Management: Flexible Reinforced Laryngeal Mask Airway and Airway Management: Endotracheal Tube in people with Anesthesia Intubation Complication and Airway, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy. Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Anesthesia Intubation Complication, Airway, Adenotonsillectomy
- What is being tested?
- Airway Management: Flexible Reinforced Laryngeal Mask Airway and Airway Management: Endotracheal Tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2023
- Phase
- Phase 2
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients who choose to have adenotonsillectomy surgery
- the American Society of Anesthesiologists (ASA) physical status ranked I-II
- the oropharyngeal anatomy is normal
- competent to provide informed consent
Who cannot join
- upper respiratory tract infection one week before surgery
- oropharyngeal anatomy is abnormal
- high risk of reflux aspiration
- liver or kidney failure
- psychiatric disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, 430000
About this study
Official title: Airway Management Effects of Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy：a Randomized Controlled Trial
The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy.
Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia .
The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA.
- Being tested
- Airway Management: Flexible Reinforced Laryngeal Mask Airway, Airway Management: Endotracheal Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Management: Flexible Reinforced Laryngeal Mask AirwayOther
In the FLMA group, a FLMA was applied according to the manufacturer's recommendations. After lubrication of the posterior surface with oxybuprocaine hydrochloride gel, the FLMA was inserted after propping the shoulders. Its cuff was fully deflated before insertion, and the pressure was adjusted to 40 cm H2O with a manometer after insertion.
Airway Management: Endotracheal TubeOther
In the ETT group, guided by a visual laryngoscope, a ETT was intubated after lubrication of the surface with oxybuprocaine hydrochloride gel: endotracheal tube size = (16+ age) /4. The cuff pressure of ETT was adjusted to 20 cm H2O with a handheld manometer after inflation.
| Study group | Role | What they receive |
|---|---|---|
| FLMA group | Experimental | In the FLMA group, a FLMA was applied. Receives: Other: Airway Management: Flexible Reinforced Laryngeal Mask Airway |
| ETT group | Experimental | In the ETT group, guided by a visual laryngoscope, a ETT was intubated. Receives: Other: Airway Management: Endotracheal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak airway pressure
Maximum peak airway pressure during surgery
Measured: intraoperative period,10 minutes-1 hours
Petco2
Petco2 at the end of surgery
Measured: intraoperative period,10 minutes-1 hour
Ventilation leakage or not
Using volume ventilation, tidal volume set to 10 ml /kg, Ventilation leakage is defined as reaching more than 20% of the set tidal volume.
Measured: intraoperative period,10 minutes-1 hour
Secondary outcomes (8)
Mean arterial pressure (MAP)
MAP level will be monitored and recorded at 6 time points, including the entry into the operation room (Time 0), 2 min after anesthesia induction (Time 1), implantation of FLMA or ETT (Time 2), implantation of mouth opener (Time 3) ，at the end of surgery (Time 4), and after removal of FLMA or ETT (Time 5)
Measured: Intraoperative period, 30 minutes - 1.5 hours
Heart rate (HR)
HR will be monitored and recorded at 4 time points, including the entry into the operation room (Time 0), 2 min after anesthesia induction (Time 1), implantation of FLMA or ETT (Time 2), implantation of mouth opener (Time 3) ，at the end of surgery (Time 4), and after removal of FLMA or ETT (Time 5)
Measured: Intraoperative period, 30 min - 1.5 hours
Recovery time
Time to fully awake, defined as by a modified Aldrete score which will be recorded every 3 minutes from the end of the procedure with a recovery index (MAS) of 9 or more.
Measured: Postoperative 30 minutes
Extubation time
Time to extubate, defined as occurrence of regular respiration from the end of the procedure.
Measured: Postoperative 30 minutes
Dosage of anesthetic
The total amount of sedative and analgesic drugs will be recorded.
Measured: Intraoperative period, 30 minutes - 1.5 hours
Success of FLMA or ETT
The first success of FLMA or ETT rate will be recorded, and insertion over three times will be considered as failed intubation.
Measured: Intraoperative period, 10 minutes - 1hour
Surgeon satisfaction
Record the satisfaction of the surgeon with the FLMA or ETT, defined as a score out of100.
Measured: Postoperative 30 minutes
Adverse events
The adverse events will be monitored and recorded during the operation and post-operation. AE will include: nausea and vomiting, reflux aspiration, hoarseness, dysphagia, sore throat, coughing, bronchospasm, laryngeal spasm, mask with blood, respiratory depression (defined as SpO2< 90%),
Measured: Postoperative 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Aug 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Hubei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Na, Maternal and Child Health Hospital of Hubei Province
- Investigators
- Na Li, MD, Principal investigator, Maternal and Child Health Hospital of Hubei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356298
- Sponsor's protocol ID
- MCHH_004
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management Effects of Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06356298
- Acronym / sponsor ID
- MCHH_004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Apr 2024 (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 goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy.
Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia .
The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLMA group | Experimental | Other: Airway Management: Flexible Reinforced Laryngeal Mask AirwayIn the FLMA group, a FLMA was applied. |
| ETT group | Experimental | Other: Airway Management: Endotracheal TubeIn the ETT group, guided by a visual laryngoscope, a ETT was intubated. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- patients who choose to have adenotonsillectomy surgery
- the American Society of Anesthesiologists (ASA) physical status ranked I-II
- the oropharyngeal anatomy is normal
- competent to provide informed consent
Key exclusion criteria (5 listed)
- upper respiratory tract infection one week before surgery
- oropharyngeal anatomy is abnormal
- high risk of reflux aspiration
- liver or kidney failure
- psychiatric disorders
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 |
|---|---|---|
| Airway Management: Flexible Reinforced Laryngeal Mask AirwayIn the FLMA group, a FLMA was applied according to the manufacturer's recommendations. After lubrication of the posterior surface with oxybuprocaine hydrochloride gel, the FLMA was inserted after propping the shoulders. Its cuff was fully deflated before insertion, and the pressure was adjusted to 40 cm H2O with a manometer after insertion. | Other | FLMA group |
| Airway Management: Endotracheal TubeIn the ETT group, guided by a visual laryngoscope, a ETT was intubated after lubrication of the surface with oxybuprocaine hydrochloride gel: endotracheal tube size = (16+ age) /4. The cuff pressure of ETT was adjusted to 20 cm H2O with a handheld manometer after inflation. | Other | ETT group |
Primary outcome
Peak airway pressure
Time frame: intraoperative period,10 minutes-1 hours
Maximum peak airway pressure during surgery
Petco2
Time frame: intraoperative period,10 minutes-1 hour
Petco2 at the end of surgery
Ventilation leakage or not
Time frame: intraoperative period,10 minutes-1 hour
Using volume ventilation, tidal volume set to 10 ml /kg, Ventilation leakage is defined as reaching more than 20% of the set tidal volume.
8 secondary outcomes
Mean arterial pressure (MAP)
Time frame: Intraoperative period, 30 minutes - 1.5 hours
Heart rate (HR)
Time frame: Intraoperative period, 30 min - 1.5 hours
Recovery time
Time frame: Postoperative 30 minutes
Extubation time
Time frame: Postoperative 30 minutes
Dosage of anesthetic
Time frame: Intraoperative period, 30 minutes - 1.5 hours
Success of FLMA or ETT
Time frame: Intraoperative period, 10 minutes - 1hour
Surgeon satisfaction
Time frame: Postoperative 30 minutes
Adverse events
Time frame: Postoperative 1 hour
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 24 Apr 2024.
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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.
Na Li, MD principal investigator
Maternal and Child Health Hospital of Hubei Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Airway Management: Flexible Reinforced Laryngeal Mask Airway and Airway Management: Endotracheal Tube in people with Anesthesia Intubation Complication and Airway, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
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 4 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 24 Apr 2024. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Peak airway pressure (time frame: intraoperative period,10 minutes-1 hours). The study lists 3 primary outcomes in all. 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 24 Apr 2024.