To compare two types of airway devices proseal LMA and i-gel in children undergoing elective surgical procedures

To compare the safety & efficacy of ProsealLMA versus i-gel in children undergoing elective surgery under spontaneous ventilation: A randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055505

Enrollment

Registered

2023-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

None listed

Interventions

Intervention1: ProsealLMA: Prosealâ??LMA{LMA-PROSEAL, PLMA} is a second generation supraglottic device. It is a reusable device.It reduces the risk of gastric insufflations and pulmonary aspiration.It

Eligibility

Inclusion criteria

Inclusion criteria: 1) ASA grade I and II. 2) Children of either sex aged 1-10 years 3) BMI 4) Mouth opening of more than 2.5cm. 5) Elective lower abdominal, minor urological and minororthopaedic surgeries of duration less than 120minutes, such as circumcision, orchidopexy, herniotomy, urethroplasty,implant exit in upper limb and lower limb

Exclusion criteria

Exclusion criteria: 1)Parent/Guardian refusal 2)Patients with active upper/lower respiratory tract infections. 3) Patients at risk of aspiration. 4) Patients with known systemic or syndromic comorbidities. 5) Patients with airway abnormalities, loose teeth.

Design outcomes

Primary

Measure	Time frame
Oropharyngeal leak pressure & successful placement meeting all 5 criteria of tidal volumes more than 6 ml per kg bilateral equal chest rise EtCO2 waveform of 30 to 35 mmHg no peak pressure elevation more than 30 cm H2O with no audible leakTimepoint: Within 10 minutes of jntubation	—

Secondary

Measure	Time frame
Ease of insertion Ease of gastric tube placement Incidence of larngospasm Incidence of Bloodstained LMA after extubation Incidence of sorethroat,hoarse cry,or any other discomfort in throat postoperativelyTimepoint: Intraoperative & postoperative period	—

Countries

India

Contacts

Public ContactAnisha Pauline L

The Tamilnadu Dr.M.G.R Medical University

drektarai@yahoo.com9789250113

Outcome results