To compare tracheal intubation with two video laryngoscopes after anesthesia induction in infants

Not yet recruiting

• Conditions: Other Procedures,

• Registration Number: CTRI/2019/01/016886
• Lead Sponsor: Department of Anesthesiology and Intensive Care

Brief Summary

Airwaymanagement is integral partof general anaesthesia. Videolaryngoscopy (VL) is a new technique that hasthe potential to facilitate endotracheal intubation and decrease adverseconsequences. In adult population the advantages of VL over directlaryngoscopy (DL) have already been proven in several studies conducted in patientswith normal and difficult airways and critically ill patient. Incomparison to adults, intubation in infant and neonates is more challenging dueto various anatomical and physiological factors.Pediatric tracheal intubations (TI) may requiremultiple attempts, especially in neonates and infants and those with a historyof difficult airway and craniofacial anomalies. But, each additional attempt isassociated with increased chances of desaturation and airway morbidity.

VLfacilitates tracheal intubation during simulated/ clinically difficultintubation in adults, but it is not clear whether these findings translate tochildren.  Comprehensive clinical studies about the efficacy of paediatric VL for routine practice in difficult airways in children are inadequate and poorly documented. Well-designed,adequately powered randomized controlled studies are necessary to addressefficacy and safety of VL for endotracheal intubation in neonates.

CMACVL has compared favorably to the conventional DL for intubation in infants andchildren. Recently,McGrath MAC blade size 1 VL has been launched which is similar to conventionalMacintosh blade. There is paucity of studies comparing CMACMiller blade VL with McGrath MAC blade VL in respect to their clinicalefficacy in infants. So,we aim to establish whether the novel McGrath MAC videolaryngoscope providesequivalent performance as compared to CMAC Miller videolaryngoscope withrespect to time to intubation in infants. We will recruit a total of 140 neonates and infants as per our inclusion and exclusion criteria as mentioned above. After standard General anesthesia they will be intubated as per their group allocation. the observations will be recorded as mentioned above.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-02-01
• Study Start: 2019-07-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

American Society of Anaesthesiologists (ASA) grade I- III.

Exclusion Criteria

Anticipated difficult airway or any such history Congenital anomalies of head and neck History of birth asphyxia Coagulation defect Any child with increased risk of aspiration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total intubation time	after intubation

Secondary Outcome Measures

Name	Time	Method
Time to glottic view, tube insertion time, ETCO2 at the end of intubation, lowest SpO2 saturation reading during the intubation, POGO score and Modified Cormack-Lehane score, intubation difficulty scores & need for optimizing manoeuvres [OELM/ head extension], successful intubation at first attempt and total number of attempts, hemodynamic parameters, complications desaturation (SPO2 95%), trauma (lip, gum, airway), mucosal bleed or esophageal intubation.

Trial Locations

Locations (1)

VMMC and Safdarjung hospital; 🇮🇳 South, DELHI, India

VMMC and Safdarjung hospital

🇮🇳South, DELHI, India

Anju Gupta

Principal investigator

9911573371

dranjugupta2009@rediffmail.com