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Clinical Trials/CTRI/2019/09/021279
CTRI/2019/09/021279CompletedNot Applicable

Comparision of endotracheal intubation between Smarttrach, C-MAC and Macintosh laryngoscopes;A randomized prospective clinical trial

Sanjay Gandhi Post Graduate Institute of Medical Sciences1 site in 1 country375 target enrollmentStarted: March 10, 2019Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
375
Locations
1
Primary Endpoint
Primary:Compare the success rates and time for intubation (i.e the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram)

Study Overview

Brief Summary

Macintosh laryngoscopes are commonly used for endo tracheal inubation. Video laryngoscopes are commonly used nowadays like CMAC and Smarttrach. We aim to compare the intubation characteristics of these three laryngoscopes in terms of their overall success rates, number of attempts, time taken, haemodnamic changes, need for external laryngeal manipulation and complications

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA I and II patients undergoing elective surgery.

Exclusion Criteria

  • Patient refusal Anticipated Difficult Airway ( Mallampatti Class III and IV, thyromental distance <6 cm; and inter-incisor distance <3.5 cm) Obesity( BMI >35) Increased intracranial pressure or cervical spine diseases cardiovascular disease endocrine disease presence of risk factors for gastric aspiration e.g. pregnancy, diabetes, etc.

Outcomes

Primary Outcomes

Primary:Compare the success rates and time for intubation (i.e the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram)

Time Frame: ( the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram) | Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation | 2) Complications like injury to the lips, teeth or tongue and any blood stain on the | device

Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation

Time Frame: ( the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram) | Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation | 2) Complications like injury to the lips, teeth or tongue and any blood stain on the | device

2) Complications like injury to the lips, teeth or tongue and any blood stain on the

Time Frame: ( the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram) | Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation | 2) Complications like injury to the lips, teeth or tongue and any blood stain on the | device

device

Time Frame: ( the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram) | Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation | 2) Complications like injury to the lips, teeth or tongue and any blood stain on the | device

Secondary Outcomes

  • 1) CL grading, need of optimization maneuvers, no.of attempts for successful ET placement, haemodynamic responses to laryngoscopy, Intubation Difficulty Score (IDS) scale, subjective ease of intubation (VAS)(2) Complications like injury to the lips, teeth or tongue and any blood stain on the)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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