Sonographic Airway Assessment to predict difficult LMA placement and Anaesthesia induced upper airway obstruction in pediatric population.

Sonographic Airway Assessment to predict difficult LMA placement and Anaesthesia induced upper airway obstruction in pediatric population.

To assess the diagnostic accuracy of suprahyoid parameters (Tongue thickness, Tongue cross-sectional area, Tongue volume, Oral cavity height, Tongue thickness/oral cavity height. Hyomental distance ratio (HMD)

PRIMARY OBJECTIVE

1.    Difficult SAD Airway ( Proseal LMA) insertion.

SECONDARY OBJECTIVES

1.    Difficult mask ventilation (grading)

2.    Time for SAD insertion.

3.    No. of attempts

4.    Failure or success

5.    Grading of SAD insertion

6.    Maneuvers needed for SAD insertion

7.    Post-operative airway obstruction

8.    Trauma during insertion, Any adverse event (Desaturation, Bradycardia etc.)

STUDY DESIGN:

Study Type – Observational

Observational method – Cohort

Time perspective – Prospective

STUDY SITE: - Paediatric patients admitted in AIIMS NEW DELHI, and planned for operation in general anaesthesia using LMA. Patients will be assessed during the preoperative visit and inside the operation theatres.

ETHICS AND CONSENT: -For conducting the study Institutional ethics committee approval will be taken and written informed consent/assent will be obtained from the parents/ legal guardians of children (Assent for children more than 8 years). This study will also be registered with clinical trial registry.

STUDY DURATION- 2 years

SAMPLE SIZE:- A full search of indexed journals (NCBI, PubMed, Index Medicus, Medline etc.) with the terms “ultrasoundâ€, “difficult LMA placement†, “postoperative airway obstructionâ€, “OSA post LMAâ€, “Pediatric difficult airway†didn’t yield any outcome. We intend to proceed as a pilot study. Sample size -300

RANDOMIZATION AND BLINDING: - There will be no randomization and concealment. Patient and the anaesthesiologist inserting the LMA will be completely blinded to the airway assessment findings. (Double Blinding)

INTERVENTION: - Device: Ultrasound, Proseal LMA

SELECTION CRITERIA

INCLUSION CRITERIA

a.    Children of age group 1-10 years.

b.   Both male and female children.

c.   Children undergoing surgery under general anesthesia using SAD.

d.   Parents or legal guardians giving consent**.**

EXCLUSION CRITERIA

1. Parents or surrogates not giving consent.

2. Patients with oropharyngeal pathology.

3. Patients with risk of aspiration.

4. Airway anomalies or syndromes related with difficult airway.

5. Presence of active pulmonary disease and poor chest compliance

6. Preoperative oxygen saturation at room air <95%

7. Tracheotomy

We will use sonography to  measure Tongue thickness, Tongue cross-sectional area, Tongue volume, Oral cavity height, Tongue thickness/oral cavity height, Hyomental distance ratio (HMD) in the operation theatre before inducing the child in order to assess

1. DIFFICULT MASK VENTILATION

later after induction and preoxygenation we will assess

2. DIFFICULT LMA PLACEMENT

An.

after LMA removal in the recovery room we will assess

3. POST OPERATIVE AIRWAY OBSTRUCTION

        These outcome parameters will be assessed and graded by the concerned anaesthesiologist and we will later co-relate the sonographic measurements and outcome parameters to prove our study.