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Clinical Trials/CTRI/2015/02/005535
CTRI/2015/02/005535Not yet recruitingNot Applicable

THE IMPACT OF TRACHEAL TUBE INTRODUCER GUIDED INTUBATION IN ANTICIPATED NON DIFFICULT AIRWAY ON POST OPERATIVE SORE THROAT

Department of Anaesthesiology Pain Perioperative Medicine1 site in 1 country450 target enrollmentStarted: February 24, 2015Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
450
Locations
1
Primary Endpoint
1.To evaluate the impact of tracheal-tube introducer guided intubation on incidence of postoperative sore throat

Study Overview

Brief Summary

Postoperative sore throat (POST) is a longstanding common negative anesthesia outcome after general anesthesia (GA) wherein conventional direct laryngoscopy-intubation (DLI) technique is employed to control upper airway. Various reasons have been placed forth and corresponding measures undertaken (e.g. tracheal tube cuff pressure control) to preclude/diminish the impact of POST but in vain. Till date, none of the efforts to prevent POST have considered mechanical factors associated with DLI as a contributing factor of POST. Since the only ‘active’ mechanical event during upper airway management comprises DLI, we presume that modification of DLI technique will reduce the forces associated with the technique and consequently, bring down incidence/severity of POST. Tracheal tube introducers (TTI), introduced to facilitate intubation in difficult airway settings, have only been employed once to improve quality-of-DLI in non-difficult airway (NDA) settings, that too with limited success. We speculate that the forces related to DLI, including, 1. Laryngoscopic mandibular lift (to expose the glottis-opening), and 2. Frictional forces generated when a tracheal tube passes the vocal cords to get into the trachea; are likely to be lesser when a tracheal-tube is guided inside the trachea with the help of a TTI. This study intends to evaluate the use of TTI in NDA in terms of their ability to bring down the impact of active DLI forces during upper airway access, and consequently, on the incidence of POST.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • ASA physical status I/II 2.Short-to-moderate duration surgery(up to 3-hours)under general anaesthesia with controlled ventilation.

Exclusion Criteria

  • 1.Anticipated difficult airway.
  • 2.Systemic illness with presenting complaints of sore/dry throat (diabetics with polydipsia, hypertensives on diuretics, moribund bed ridden patients).
  • 3.Neurosurgical patients with active ICP considerations.
  • 4.History of airway related morbidity (POST, mucosal trauma) 5.Recent head and neck, intraoral/nasal surgery.
  • 6.Psychiatric and substance abuse patients.
  • 7.Ongoing upper and lower respiratory tract inflammation/infection.
  • 8.Bleeding diathesis, steroid dependence 9.Consent refusal.

Outcomes

Primary Outcomes

1.To evaluate the impact of tracheal-tube introducer guided intubation on incidence of postoperative sore throat

Time Frame: From arrival in the postoperative recovery room till 24 hours

Secondary Outcomes

  • 1.Intubation attempts(2.Laryngoscopy-intubation time)

Investigators

Sponsor
Department of Anaesthesiology Pain Perioperative Medicine
Sponsor Class
Research institution and hospital

Study Sites (1)

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