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Completed

NCT Number: NCT06356298

Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy

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.

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Key information

Conditions

Anesthesia Intubation Complication Adenotonsillectomy Airway Children

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • upper respiratory tract infection one week before surgery
  • oropharyngeal anatomy is abnormal
  • high risk of reflux aspiration
  • liver or kidney failure
  • psychiatric disorders

Treatment and study plan

Airway Management: Flexible Reinforced Laryngeal Mask Airway

Other

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 Tube

Other

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.

Primary outcomes

  1. Peak airway pressure

    Time frame: intraoperative period,10 minutes-1 hours

    Maximum peak airway pressure during surgery

  2. Petco2

    Time frame: intraoperative period,10 minutes-1 hour

    Petco2 at the end of surgery

  3. 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.

Secondary outcomes

  1. Mean arterial pressure (MAP)

    Time frame: Intraoperative period, 30 minutes - 1.5 hours

    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)

  2. Heart rate (HR)

    Time frame: Intraoperative period, 30 min - 1.5 hours

    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)

  3. Recovery time

    Time frame: Postoperative 30 minutes

    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.

  4. Extubation time

    Time frame: Postoperative 30 minutes

    Time to extubate, defined as occurrence of regular respiration from the end of the procedure.

  5. Dosage of anesthetic

    Time frame: Intraoperative period, 30 minutes - 1.5 hours

    The total amount of sedative and analgesic drugs will be recorded.

  6. Success of FLMA or ETT

    Time frame: Intraoperative period, 10 minutes - 1hour

    The first success of FLMA or ETT rate will be recorded, and insertion over three times will be considered as failed intubation.

  7. Surgeon satisfaction

    Time frame: Postoperative 30 minutes

    Record the satisfaction of the surgeon with the FLMA or ETT, defined as a score out of100.

  8. Adverse events

    Time frame: Postoperative 1 hour

    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%),

Sponsors and collaborators

Lead sponsor

Maternal and Child Health Hospital of Hubei Province

Other

Registry information

Official study title

Airway Management Effects of Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy：a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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