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Clinical Trials/NCT05218707
NCT05218707
Recruiting
Not Applicable

Influence of Oropharyngeal Airway on the Incidence of Airway Complications Following LMA Removal Under Deep Anaesthesia in Children

Aga Khan University1 site in 1 country230 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Complication of Anesthesia
Sponsor
Aga Khan University
Enrollment
230
Locations
1
Primary Endpoint
Oxygen saturation
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Laryngeal Mask Airway has been used in paediatric anaesthesia since the 1990's. Clinical practice in paedeatric anaesthesia for Laryngeal Mask Airway removal varies and there is no standard of care.

In children removing the Laryngeal Mask Airway under deep inhalational anaesthesia has some advantages compared to awake, but may be associated with higher rate of complications when Laryngeal Mask Airway is removed in supine compared to lateral position. On the other hand deep anaesthesia may cause airway obstruction due to reduction in tone of upper airway muscles in some patients. An oropharangeal airway may prevent this. This aspect had not been studied before and represent a gap in literature.

Study Hypothesis:

Airway complications associated with Laryngeal Mask Airway removal under deep anaesthesia are same with or without insertion of an oral airway. Alternate hypothesis is that airway complications be less if an air way is inserted at the end of anaesthesia.

Objective:

The present study was designed to observe any difference in immediate complication after removal of LMA in supine head down position under deep anaesthesia with or without insertion of an oro-pharyngeal airway. Airway complications that we will observe are desaturation <92%, stridor, excessive secretions, laryngospasm, retching, vomiting, coughing, trauma to the soft tissues and damage to the teeth.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Khalid Siddiqui

Assistant Professor

Aga Khan University

Eligibility Criteria

Inclusion Criteria

  • ASA I and II patients aged 2-10 years undergoing surgery where anaesthesia with LMA is considered appropriate.

Exclusion Criteria

  • Patients undergoing surgery involving soiling of the airway
  • Patients with conditions associated with higher incidence of gastrooseophageal reflux
  • Presence of active upper respiratory tract infection (URI)
  • Emergency Surgery

Outcomes

Primary Outcomes

Oxygen saturation

Time Frame: Day 1

Oxygen saturation \<92% will be considered as complication

Stridor

Time Frame: Day 1

The presence of noisy breathing occurring through obstructed airflow. We clinically measure it by auscultation of the nose, oropharynx, neck and chest.

Secondary Outcomes

  • laryngospasm(Day 1)

Study Sites (1)

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