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Oropharyngeal Airway and Airway Complications

A

Aga Khan University

Status

Enrolling

Conditions

Airway Complication of Anesthesia

Treatments

Other: GUEDEL Airway

Study type

Observational

Funder types

Other

Identifiers

NCT05218707
2021-5669-19713

Details and patient eligibility

About

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.

Enrollment

230 estimated patients

Sex

All

Ages

2 to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

230 participants in 2 patient groups

Group A
Description:
An appropriate size oropharyngeal airway (GUEDEL) will be inserted immediately after removal of LMA and time will be noted. (Size will be chosen by placing the flange at the corner of the mouth and tip at the angle of the jaw).
Treatment:
Other: GUEDEL Airway
Group B
Description:
In Group B No oropharyngeal airway (GUEDEL) will be inserted.

Trial contacts and locations

1

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Central trial contact

Khalid Maudood Siddiqui, FCPS; Shemila Abbasi, FCPS

Data sourced from clinicaltrials.gov

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