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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.

Not Applicable
Conditions
Health Condition 1: Q378- Unspecified cleft palate with bilateral cleft lip
Registration Number
CTRI/2019/05/019289
Lead Sponsor
Jawaharlal institute of postgraduate medical education and research institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

-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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
TO COMPARE THE TIME TAKEN FOR SECURING THE TRACHEA USING ORAL RAE TUBE WITH AND WITHOUT FROVA INTRODUCERTimepoint: DURATION IN SECONDS <br/ ><br>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 Outcome Measures
NameTimeMethod
- TO COMPARE FIRST ATTEMPT SUCCESS RATE <br/ ><br>-TO COMPARE CL(CORMACK LEHANE) GRADING <br/ ><br>-TO OBSERVE HAEMODYNAMIC RESPONSES ASSOCIATED WITH EACH TECHNIQUE <br/ ><br>-TO OBSERVE THE REASONS FOR FAILED INTUBATIONS. <br/ ><br>-TO OBSERVE ANY AIRWAY COMPLICATIONS.Timepoint: -NO OF ATTEMPTS FOR TRACHEAL INTUBATION. <br/ ><br>-THE INTUBATORS OPINION BEFORE INTUBATION REGARDING THE VIEW OF GLOTTIS ASSESED USING CL GRADING 1-4 <br/ ><br>-BASELINE HR, NIBP AND SPO2 AFTER INDUCTION, BEFORE AND IMMEDIATELY AFTER INTUBATION FOR EVERY MIN TILL 5 MINUTES AFTER INTUBATION <br/ ><br>-NO. OF FAILED INTUBATION AND REASONS FOR FAILURE ARE NOTED <br/ ><br>-PATIENTS WILL BE REVIEWED 24 HOURS AFTER SURGERY TO ASSESS FOR THE PRESENCE OF POST OPERATIVE COMPLICATIONS LIKE LARYNGOSPASM
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