Using ultrasound scan to look for upper airway in children and to predict difficult upper airway tube placement and post operative airway obstruction.
- Conditions
- Infantile and juvenile cataract,
- Registration Number
- CTRI/2023/07/055874
- Lead Sponsor
- AIIMS NEW DELHI
- Brief Summary
**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.
1.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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 Abbas poor chest complains.
- 6.Preoperative oxygen saturation at room air <95% 7.Tracheotomy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of Difficult Laryngeal Mask Airway Placement Before the induction of anaesthesia to the patient in the pre operative room on the same day of the surgery .
- Secondary Outcome Measures
Name Time Method 1.Assessment of Difficult Mask Ventilation. 2. Assessment of post operative airway obstruction.
Trial Locations
- Locations (1)
AIIMS NEW DELHI
🇮🇳South, DELHI, India
AIIMS NEW DELHI🇮🇳South, DELHI, IndiaDr Arshad AyubPrincipal investigator9953542344drarshad2k1@gmail.com