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Comparing Two Devices for Safe Airway Tube Pressure Measurement in Children Under Anaesthesia

Comparison of efficacy of measuring cuff pressure of LMA by AG Cuffill pressure measuring device versus CuffSure by Tuoren in paediatric population under general anaesthesia with controlled mechanical ventilation - nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089747
Enrollment
150
Registered
2025-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: K20-K31- Diseases of esophagus, stomach and duodenum

Interventions

Intervention1: cuff pressure measured by either of device at volume of air according to previous standered guidelines.: cuff pressure measured at different intervals. Intervention2: cuff pressure meas

Sponsors

Lala Lajpat Rai Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient guardian giving written consent for general anaesthesia. Age 2 year to 10 years. Patients underweight category of 10 to 30kg. ASA I and II Surgery of less than 2 hours

Exclusion criteria

Exclusion criteria: ASA III and IV Known -drug allergy to General anaesthesia drug Oral pathology like tonsils, lesion in oral cavity, restricted mouth opening Long duration surgery more than 2 hours Difficult airway MPG III and IV Laparoscopic surgery Any surgery in which excessive neck positioning is required, requires ryles tube Patients with known airway abnormalities. History of gastroesophageal reflux disease (GERD). Patients requiring endotracheal intubation instead of an LMA. Allergy or contraindication to the LMA used in the study.

Design outcomes

Primary

MeasureTime frame
Measurement of LMA cuff pressure by both devices and their comparison of in which device patient groups, show more complications in post operative period at above particular cuff pressureTimepoint: 5min 10 min 15 min 30min 60min 75min 90min 105min 120min

Secondary

MeasureTime frame
Post-op complication (Pharngolaryngeal events like Sore throat) Ease of placement No of attempts of insertion Haemodynamic changes Conversion to Endotracheal tube intubationTimepoint: after extubation after 6 hr after 12 hr after 24 hour

Countries

India

Contacts

Public ContactPushpendra Kumar Saini

LLR Hospital and GSVM Medical College Kanpur Nagar

drapurva.agarwal@gmail.com9415368678

Outcome results

None listed

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