Extubation for Pediatric Anesthesia

(BELUGA Trial)

Not yet recruiting at 7 trial locations

Overseen By Lliana B Slevin, BSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Telethon Kids Institute

Disqualifiers: Severe cardiopulmonary disease, Difficult airway, Major airway surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for removing breathing tubes in children after surgery. One method removes the tube as the child wakes up, while the other removes it under anesthesia, using a Laryngeal Mask Airway (LMA) to assist breathing until the child is fully awake. The goal is to determine which method results in fewer breathing problems post-surgery. Children requiring surgery with a breathing tube, who do not have severe heart or lung issues, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance post-surgical care for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these extubation techniques are safe for pediatric patients?

Research shows that using a Laryngeal Mask Airway (LMA) in children is generally very safe. Studies have found that the LMA has a low rate of complications. For instance, one study reported a complication rate of just 0.19%, with no major health issues noted.

The LMA also helps maintain stable conditions during surgeries in children. In most cases, it worked well, with only a few needing to switch to another method. This indicates that the LMA is well-tolerated and safe for children.

Overall, based on current research, using an LMA seems to have fewer risks compared to other methods like endotracheal tubes, making it a safe choice for children having surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different extubation techniques for pediatric anesthesia, aiming to improve safety and comfort for young patients. The "Group ETT awake" approach waits for the child to be fully awake before removing the endotracheal tube, ensuring that they meet specific criteria like eye-opening or purposeful movement, which might reduce the risk of airway complications. On the other hand, the "Group LMA exchange" method involves removing the tube while the child is still under deep anesthesia and replacing it with a Laryngeal Mask Airway (LMA), possibly minimizing distress and discomfort during the wake-up process. By comparing these two methods, researchers hope to identify the most effective and gentle approach for extubating children after surgery.

What evidence suggests that these extubation techniques could be effective for reducing postoperative respiratory adverse events in pediatric patients?

This trial will compare two extubation methods in pediatric anesthesia: one group will have the endotracheal tube (ETT) removed once the patient is fully awake, while another group will have the ETT removed under deep anesthesia and replaced with a laryngeal mask airway (LMA). Research has shown that using an LMA during surgery often results in fewer breathing problems compared to an ETT. For instance, patients with an LMA tend to cough less as they wake up from anesthesia. One study found that using an LMA also caused fewer increases in heart rate before surgery began. The LMA is generally easier to insert, with success rates as high as 96.1%. Overall, the LMA can lead to a smoother recovery with fewer breathing issues. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

The BELUGA trial is for children undergoing surgery under general anesthesia who require an endotracheal tube (ETT) for ventilation. Specific eligibility criteria are not provided, but typically participants would be pediatric patients without contraindications to the study procedures.

Inclusion Criteria

My child is between 0-16 years old, weighs more than 5kg, and needs surgery requiring general anesthesia and an endotracheal tube.

Exclusion Criteria

Children with a contraindication to deep removal of ETT deep or exchange of ETT to LMA at the end of the case (e.g. high risk of aspiration)

My child has a serious heart or lung condition.

My child weighs less than 5kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Randomized to either awake removal of ETT or deep removal of ETT and exchange to LMA during surgery

8 weeks

Continuous monitoring during surgery and PACU stay

Follow-up

Participants are monitored for respiratory adverse events, pain, delirium, and other outcomes post-surgery

2-4 hours post PACU discharge

Monitoring in PACU and follow-up assessments

Data Collection

Data collection in 8-week blocks until sample size is reached

Until sample size is reached

What Are the Treatments Tested in This Trial?

Interventions

• Laryngeal Mask Airway

Trial Overview This trial tests whether exchanging an ETT for a laryngeal mask airway (LMA) after deep extubation is better than removing the ETT when the child is awake. It aims to see which method leads to fewer postoperative respiratory problems like coughing or airway blockage.

How Is the Trial Designed?

Group I: Group ETT awake Active Control 1 Intervention

ETT removal once the patient is fully awake (at least 3 of the following criteria: spontaneous tidal volume \>5ml/kg, conjugate gaze, facial grimace, eye-opening, purposeful movement)

Group II: Group LMA exchange Active Control 1 Intervention

ETT removal deep; @ at least 1 Mac or an equivalent depth of anaesthesia (if available BIS\<60, Sedline \<50), an additional bolus of propofol (1mg/kg) maybe given if deemed appropriate/ required prior to the ETT removal. Following gentle suctioning around the ETT at the end of the case, the ETT is removed under deep anaesthesia and a LMA inserted.

Who Is Running the Clinical Trial?

Telethon Kids Institute

Lead Sponsor

Trials

16

Recruited

21,100+

Uppsala University Hospital

Collaborator

Trials

188

Recruited

749,000+

Atrium Health Wake Forest Baptist

Collaborator

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Insel Gruppe AG, University Hospital Bern

Collaborator

Trials

831

Recruited

2,353,000+

University of Sao Paulo

Collaborator

Trials

1,091

Recruited

266,000+

Istituto Giannina Gaslini

Collaborator

Trials

47

Recruited

140,000+

Child and Adolescent Health Service - Perth

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3237161/

Laryngeal mask airway vs the endotracheal tube in ... The LMA had three advantages over the tracheal tube in the form of statistically lower incidence of cough during emergence, lower incidence of postoperative ...

2. tp.amegroups.org tp.amegroups.org/article/view/143547/html

Laryngeal mask versus intubation on adverse reactions in ... Results: In total, 39.66% (23/58) of the patients received LMA. Patients with LMA placement in Group B had a significantly lower HR before skin ...

3. brieflands.com brieflands.com/articles/aapm-13884

Comparison of the Success Rate of Laryngeal Mask Air ... Successful insertion of pediatric LMA at the first attempt has been reported to be 67% to 92% (12, 13). Several techniques have been proposed to insert LMA, and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818096002176

Removal of the laryngeal mask airway in children Conclusion. Removal of the LMA during anesthesia and after return of airway reflexes results in a similar incidence of airway problems in children.

5. tandfonline.com tandfonline.com/doi/full/10.1080/11101849.2023.2180577

Efficacy of the laryngeal mask airway gastro during trans- ... LG insertion success rate was 96.1% (95.9% at first attempt) and ease of insertion was reported in 91.9% of patients. Short extubation time and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2900102/

A Study of the Use of Laryngeal Mask Airway (LMA) in ... Insertion of LMA was easier in 94% patients while endotracheal intubation was done easily in 53% of patients only (p<0.05). The changes in haemodynamic ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0196070925000444

Laryngeal mask airway in pediatric tonsillectomy and ... We found a low complication rate of 0.19 % and no significant clinical complications. Our study provides data on the safety and efficacy of LMA use in these ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ped4.12401

Safety of removal of ProSeal laryngeal mask airway in ... The use of the laryngeal mask airway (LMA) in children has been found to be very safe and efficacious in various studies. ... In adult patients ...

9. theajo.com theajo.com/article/view/4373/html

further evidence for safety of the laryngeal mask airway Results: In total, 95.4% of cases were completed successfully under LMA, and 1.4% of cases required transition from an LMA to an endotracheal ...