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Clinical Trials/CTRI/2019/11/021969
CTRI/2019/11/021969Not yet recruitingPhase 1

COMPARISON BETWEEN BRONCHOSCOPY GUIDED AND REAL TIME ULTRASOUND GUIDED PERCUTANEOUS TRACHEOSTOMY USING GRIGGS TECHNIQUE

Department of Anaesthesiology and critical care1 site in 1 country60 target enrollmentStarted: November 11, 2019Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To see total time duration taken for fiber optic bronchoscopy guided and real time ultrasound guided percutaneous tracheostomy using griggs technique.

Study Overview

Brief Summary

ABSTRACT

Comparison between bronchoscopy guided and real time ultrasound guided percutaneous tracheostomy using Griggs technique.

INTRODUCTION

Percutaneous tracheostomy is usually performed in critically ill patients in intensive care units. It is usually done under fiber optic guidance to allow needle insertion while protecting the real wall damage and to verify cannula location. However, requirement of specialized equipment and staff with specific experience experience, together with possibility of acutely elevated intracranial pressure limits the use of fiber optic in acute brain damage patients.

The use of ultrasound guidance for percutaneous tracheostomy has increased recently with advanatge of portability,safety,pain free , identification of thyroid gland and vascular structures, determination of correct tracheal space and guidance of needle into trachea.

Objectives of our study is to compare efficacy, time taken for each procedure, no of needle puncture attempt, complications and evaluate their accuracy which is defined by wheter puncture is at the centre, site puncture space and visualization of Griggs forcep tip in the space.

MATERIALS AND METHOD:

The study will include 60 patients, 30 in each group.

Primary outcome: total time taken by each procedure.

Secondary outcome: compare no of needle puncture attempts

incidence of complications and accuracy. Accuracy is defined by wheter puncture is at centre, puncture space and visualization of griggs forcep tip in the space.

RESULT:

The above parameters will be recorded and compared.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients expected to be on prolong mechanical ventilation(>7 days) INR MAXIMUM 1.4.

Exclusion Criteria

  • •Laryngeal/oesophageal/tracheal carcinoma Soft tissue infection of neck Anatomical deformity of neck including enlarged thyroid gland Haematological and terminal malignancies Coagulation disorder Previous tracheostomy Platelet count less than or equal to 80,000.

Outcomes

Primary Outcomes

To see total time duration taken for fiber optic bronchoscopy guided and real time ultrasound guided percutaneous tracheostomy using griggs technique.

Time Frame: 18 months

Secondary Outcomes

  • to compare number of needle puncture attempts(incidence of complications of these proceduresand to see accuracy which is defines as wheter puncture is at the centre , site of puncture space and visualization of griggs forcep time in the space.)

Investigators

Sponsor
Department of Anaesthesiology and critical care
Sponsor Class
Government medical college

Study Sites (1)

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