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comparison of two techniques for introducing tube into the trachea(wind pipe)of children with anatomical defects like cleft lip and cleft palate given general anaesthesia for routine surgeries, using oral tube with and without a tracheal introducer called Frova.

comparison of ease of intubation using oral RAE( Ring-Adair-Elwyn) tube with and without premounted Frova intubating introducer in pediatric patients undergoing cleft lip and cleft palate surgeries: A Randomised clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019289
Enrollment
80
Registered
2019-05-23
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: Q378- Unspecified cleft palate with bilateral cleft lip

Interventions

Intervention1: INTUBATION USING ORAL RAE TUBE WITH PREMOUNTED FROVA INTUBATING INTRODUCER: ENDOTRACHEAL INTUBATION WILL BE DONE BY ANESTHESIA RESIDENTS USING ORAL RAE TUBE WITH FROVA INTUBATING INTROD

Sponsors

Jawaharlal institute of postgraduate medical education and research institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ALL PEDIATRIC PATIENTS WITH AGE 6 MONTHS TO 4 YEARS UNDERGOING CLEFT LIP AND CLEFT PALATE SURGERIES IN JIPMER, BELONGING TO ASA CLASS 1-2 PLANNED FOR GENERAL ANESTHESIA WITH ORAL RAE TUBE INTUBATION WILL BE INCLUDED IN THE STUDY

Exclusion criteria

Exclusion criteria: -LIMITED MOUTH OPENING -ANTICIPATED DIFFICULT AIRWAY IN SYNDROMIC PATIENTS -HISTORY OF RECENT RESPIRATORY TRACT INFECTIONS -EVIDENCE OF PULMONARY DISEASES(ASTHMA, PNEUMONIA)- -PARENT REFUSAL TO PARTICIPATE IN THE STUDY

Design outcomes

Primary

MeasureTime frame
TO COMPARE THE TIME TAKEN FOR SECURING THE TRACHEA USING ORAL RAE TUBE WITH AND WITHOUT FROVA INTRODUCERTimepoint: DURATION IN SECONDS TIME FOR INTUBATION IS RECORDED AS THE INTERVAL BETWEEN INTRODUCTION OF LARYNGOSCOPIC BLADE INTO PATIENTS MOUTH TO THE APPEARANCE OF CAPNOGRAPHIC TRACE IN THE MONITOR. IT IS DONE DURING INTUBATION UNDER GENERAL ANESTHESIA—

Secondary

MeasureTime frame
- TO COMPARE FIRST ATTEMPT SUCCESS RATE -TO COMPARE CL(CORMACK LEHANE) GRADING -TO OBSERVE HAEMODYNAMIC RESPONSES ASSOCIATED WITH EACH TECHNIQUE -TO OBSERVE THE REASONS FOR FAILED INTUBATIONS. -TO OBSERVE ANY AIRWAY COMPLICATIONS.Timepoint: -NO OF ATTEMPTS FOR TRACHEAL INTUBATION. -THE INTUBATORS OPINION BEFORE INTUBATION REGARDING THE VIEW OF GLOTTIS ASSESED USING CL GRADING 1-4 -BASELINE HR, NIBP AND SPO2 AFTER INDUCTION, BEFORE AND IMMEDIATELY AFTER INTUBATION FOR EVERY MIN TILL 5 MINUTES AFTER INTUBATION -NO. OF FAILED INTUBATION AND REASONS FOR FAILURE ARE NOTED -PATIENTS WILL BE REVIEWED 24 HOURS AFTER SURGERY TO ASSESS FOR THE PRESENCE OF POST OPERATIVE COMPLICATIONS LIKE LARYNGOSPASM—

Countries

India

Contacts

Public ContactSANDEEP KUMAR MISHRA

Jawaharlal institute of postgraduate medical education and research institute

jipmermishra@gmail.com9344668104

Outcome results

None listed

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