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Comparison of two methods of inserting a breathing device in children during anaesthesia: standard digital method versus Macintosh laryngoscope guided method for better placement.

Comparison between standard digital insertion and Macintosh direct laryngoscope guided technique of ProSeal laryngeal mask airway insertion in children: a double blind randomized study - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106466
Enrollment
100
Registered
2026-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Macintosh Direct Laryngoscope Guided ProSeal Laryngeal Mask Airway Insertion: Insertion of ProSeal Laryngeal Mask Airway using Macintosh direct laryngoscope guided technique in paediatr

Sponsors

Institute of Post Graduate Medical Education and Research and SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA physical status 1 and 2 2. Aged between 2 to 12 years of age of either sex 3. Patients undergoing urethroplasty, orchidopexy, hernia repair, circumcision, cystoscopy with fulguration of posterior urethral valve and any other superficial abdominal surgery such as excision of umbilical granuloma, excision of sebaceous cyst or lipoma under general anaesthesia 4. Anticipated duration of surgery should be less than 2 hours

Exclusion criteria

Exclusion criteria: 1. Refusal to consent 2. Known case of difficult airway 3. History of allergy to study drugs 4. Patients having cardiorespiratory disease or oropharyngeal pathology 5. Diseases related to cervical spine 6. Aspiration risk 7. If patients require ventilator support postoperatively 8. Surgery with anticipated duration of more than 2 hours will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Proportion of children with optimal placement of ProSeal Laryngeal Mask Airway in standard digital blind insertion method versus Macintosh direct laryngoscope guided techniqueTimepoint: Immediately after insertion of ProSeal Laryngeal Mask Airway—

Secondary

MeasureTime frame
Procedure time, number of insertion attempts, oropharyngeal leak pressure, ease of gastric tube placement & adverse events, if any, such as blood stain over LMA on removal; hoarseness, cough at 1 hour in the postoperative period.Timepoint: During insertion of ProSeal Laryngeal Mask Airway, immediately after placement & at 1 hour postoperative period.—

Countries

India

Contacts

Public ContactDr Mohanchandra Mandal

Institute Of Post Graduate Medical Education And Research And SSKM Hospital

drmcmandal@gmail.com9433072820

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026