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comparing 2 techniques for securing a tube in trachea for giving anaesthesia in children

Comparison of Supraglottic assisted fiberoptic intubation (SAFI) with video assisted fiberoptic intubation (VAFI) in children requiring endotracheal intubation for elective surgery among trainees: SAVIO Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095465
Enrollment
70
Registered
2025-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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: VAFI:Videolaryngoscope assisted fiberoptic intubation: Patients will undergo endotracheal intubation with Videolaryngoscope assisted fiberoptic intubation 4 minutes after induction of a

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Paediatric patients of ASA status I and II in the age range of 1month -2 years of either gender Requiring endotracheal intubation for undergoing elective surgery

Exclusion criteria

Exclusion criteria: Patient s parental Refusal Anticipated Difficult Airway Tonsillar/adenoid hyperplasia Congenital airway anomalies Coagulation defects History of a recent upper respiratory tract infection or significant pulmonary disease Children requiring RSI (Full stomach, Active GERD) Severe Obstructive sleep apnea ASA Physical status 3 or higher

Design outcomes

Primary

MeasureTime frame
The time taken to perform tracheal intubationTimepoint: 1 second after intubation

Secondary

MeasureTime frame
First pass success rateTimepoint: 30 seconds At the end of intubation;glottic visualization using Cormack & Lehane glottic score (CL)Timepoint: 30 seconds after laryngoscopy;intubation difficulty scoreTimepoint: 30 seconds after intubation;ComplicationsTimepoint: 1 hour after the end of surgery

Countries

India

Contacts

Public ContactDivya Jain

Postgraduate Institute of medical education and research

Jaindivya77@rediffmail.com09855900171

Outcome results

None listed

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