Laryngeal mask airway versus endotracheal tube for children having laparoscopic inguinal hernia repair
Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Multicenter, Prospective, Randomized Controlled Clinical Trial
This trial will test whether using a laryngeal mask airway instead of an endotracheal tube helps children aged 1–10 breathe safely and recover faster during laparoscopic inguinal hernia repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 1 Year to 10 Years |
| Sex | All |
| Sponsor | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital Academic / other |
| Locations | 1 site (Diyarbakır, Eyalet/Yerleşke) |
| Trial ID | NCT07511764 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective, randomized controlled trial enrolling 266 pediatric patients (age 1–10, ASA I–II) undergoing elective laparoscopic inguinal hernia repair. Patients are randomly assigned to general anesthesia with either a laryngeal mask airway (LMA, n=133) or endotracheal intubation (ETT, n=133) with standardized anesthesia protocols across centers. The study will compare intraoperative airway parameters (for example peak airway pressure), perioperative safety events, and recovery metrics such as time to meet discharge criteria. The design aims to provide adequately powered, multicenter evidence on whether LMA offers a less invasive alternative to ETT in this population.
Who should consider this trial
Good fit: Ideal candidates are children aged 1–10 years with ASA I–II who are scheduled for elective laparoscopic inguinal hernia repair and whose parents provide informed consent.
Not a fit: Children with obesity (>95th percentile), symptomatic gastroesophageal reflux or other high aspiration risk, upper airway anomalies, history of difficult intubation, acute respiratory infection, emergency surgery, need for conversion to open surgery, or significant systemic disease (eg, immunodeficiency or malignancy) are excluded and unlikely to benefit from the trial results.
Why it matters
Potential benefit: If successful, the LMA approach could reduce airway invasiveness and shorten recovery time for many children having laparoscopic inguinal hernia repair.
How similar studies have performed: Smaller randomized trials and meta-analyses have suggested that LMA can be safe for pediatric laparoscopy and may lower peak airway pressure and speed recovery, but no large multicenter randomized trial has definitively confirmed this.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: being between 1 and 10 years of age, having a planned laparoscopic inguinal hernia repair, being classified as ASA I-II, having given informed consent from the parent. Exclusion Criteria: Obesity (body weight \>95th percentile), symptomatic gastroesophageal reflux, high risk of aspiration, upper airway anomalies, history of difficult intubation, acute respiratory tract infection, emergency surgical indication, need for conversion from laparoscopy to open surgery, presence of additional systemic risks such as immunodeficiency/malignancy.
Where this trial is running
Diyarbakır, Eyalet/Yerleşke
- Dicle University — Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Fikret Salık, associate professor
- Email: fikretsalik@gmail.com
- Phone: +905076214125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.