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Proseal LMA Insertion using introducer tool and suction catheter in children

Randomised Controlled Trial of Suction Catheter Versus Introducer Tool Guided Proseal-LMA Insertion in Paediatric Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013012
Enrollment
120
Registered
2018-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Healthy paediatric patients ASA I and II for elective surgeries

Interventions

Intervention1: Suction catheter guided Proseal insertion: Ease of insertion and Success rate noted Control Intervention1: Introducer Tool guided Proseal LMA insertion: The ease of insertion and succe

Sponsors

Vijayanagar Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Posted for elective surgeries between 5-30 Kg,ASA I and II After induction of general anaesthesia, Proseal is inserted as per the allocation and the parameters are noted.

Exclusion criteria

Exclusion criteria: Patients with known or predicted difficult airway or patients at risk of aspiration. Presence of significant co-morbidities or recent or active respiratory tract infection.

Design outcomes

Primary

MeasureTime frame
The ease of insertion (number of attempts and time taken to provide an effective airway with first attempt success rate of insertionTimepoint: The Primary Outcome Parameter is assessed after pLMA insertion in two groups, at 1min,2min,3min,4min,5min, or max. 3 attempts of insertion

Secondary

MeasureTime frame
Efficacy of airway seal. Any episodes of desaturation (SpO2 90 %) or other adverse events. Heart rate and BP changes before, during and after insertion. Any visible blood staining on suction catheter, laryngoscope / PLMAâ?¢ noted at removal. Any trauma to mouth, lips and tongue. After 18-24 hrs postoperatively, patients or parents were asked about sore throat (constant pain even without swallowing), dysphonia (difficulty or pain on speaking), dysphagia (difficulty or pain on swallowing). Timepoint: Upto 24 h post operatively

Countries

India

Contacts

Public ContactBala Bhaskar S

PG Trainee, Dep of Anaesthesiology VIMS Ballari

drsripriya_siva@yahoo.co.in7829924546

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026