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Clinical Trials/CTRI/2022/09/045457
CTRI/2022/09/045457Not yet recruitingPhase 3

A comparative evaluation of conventional Macintosh laryngoscope and C-MAC video laryngoscope using an aerosol box: A prospective randomized study.

Department of Anaesthesiology and Critical Care1 site in 1 country120 target enrollmentStarted: September 15, 2022Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
The primary outcome measure shall be the time required for a successful tracheal intubation.

Study Overview

Brief Summary

A comparative evaluation of conventional Macintoshlaryngoscope and C-MAC video laryngoscope using an aerosol box: A prospectiverandomized study.

The incidence of respiratory illnesses is on the rise.In most of these infections, airway secretions and aerosol generation is thesource of spread [1]. Often healthcare workersin the peripheral regions work under low resource settings and don’t haveadequate protective equipment to safeguard themselves against infections byemploying various innovations in their practice and protocols. The Aerosol box is one such innovation which is acheap and easy to make acrylic box that can be used as a barrier between thepatient and the healthcare provider.

Videolaryngoscopes have been preferred choice inmany studies because of various advantages and assumption that they take lessertime to intubate and offer better glottic visualization. However, in patientswith normal airway and without aerosol box, it has been found that a goodvisualization is not always related to a good success rate. The success rateand intubation times were comparable to conventional laryngoscopes in many suchstudies. The evidence on realpatients is lacking and there is relative scarcity of literature on patients assubjects. It is imperative to know the best way to intubate a patient using anaerosol box in order to save time and resources.

Therefore, wedesigned this study with the primary aim to compare the intubation time between aconventional Macintosh laryngoscope and C-MAC videolaryngoscope using anaerosol box in patients with normal airway.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA Grade I & II, BMI.
  • <30, MP class – 1 & 2.

Exclusion Criteria

  • Decreased inter-incisor distance (<3 cm), Short thyromental distance (<6 cm), Any facial anomaly, Fixed flexion deformity, Patient at risk of pulmonary aspiration.

Outcomes

Primary Outcomes

The primary outcome measure shall be the time required for a successful tracheal intubation.

Time Frame: Insertion of laryngoscope till immediately post intubation

Secondary Outcomes

  • The number of intubation attempts, Intubation difficulty score, The rate of successful placement of the TT in the trachea, Number of optimization maneuvers required (use of a bougie, external laryngeal pressure) to aid in tracheal intubation, The Cormack Lehane grade at laryngoscopy, Hemodynamic changes during intubation, The Percentage Of Glottic Opening (POGO) score at laryngoscopy, Immediate complications

Investigators

Sponsor
Department of Anaesthesiology and Critical Care
Sponsor Class
Government medical college

Study Sites (1)

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