Clinical trial NCT05218707: Oropharyngeal Airway and Airway Complications
Official title: Influence of Oropharyngeal Airway on the Incidence of Airway Complications Following LMA Removal Under Deep Anaesthesia in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Airway Complication of Anesthesia
Keywords: laryngeal mask airway
Oropharyngeal Airway
Deep Anaesthesia
Children
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 230
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 2-10 years undergoing surgery where anaesthesia with Laryngeal Mask Airway insertion.

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.


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

Primary outcomes:
measure: Oxygen saturation
timeFrame: Day 1
measure: Stridor
timeFrame: Day 1
Secondary outcomes:
measure: laryngospasm
timeFrame: Day 1
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References:
citation: Mason DG, Bingham RM. The laryngeal mask airway in children. Anaesthesia. 1990 Sep;45(9):760-3. doi: 10.1111/j.1365-2044.1990.tb14449.x.
citation: Thomas-Kattappurathu G, Kasisomayajula A, Short J. Best position and depth of anaesthesia for laryngeal mask airway removal in children: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):624-30. doi: 10.1097/EJA.0000000000000286.
citation: Sinha A, Sood J. Safe removal of LMA in children - at what BIS? Paediatr Anaesth. 2006 Nov;16(11):1144-7. doi: 10.1111/j.1460-9592.2006.01978.x.