Oropharyngeal Airway and Airway Complications

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

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Other: GUEDEL Airway

• Study Type: Observational
• Enrollment (Estimated): 230

Contacts and Locations

• Study Contact: Name: Khalid Maudood Siddiqui, FCPS; Phone Number: +922134862896; Email: khalid.siddiqui@aku.edu
• Study Contact Backup: Name: Shemila Abbasi, FCPS; Phone Number: +922134864632; Email: shemila.abbasi@aku.edu

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Recruiting
      • Aga Khan University Hospital
      • Contact: Khalid Maudood Siddiqui, FCPS; Phone Number: 2899 00922134862899; Email: khalid.siddiqui@aku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Children aged 2-10 years undergoing surgery where anaesthesia with Laryngeal Mask Airway insertion.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; 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).	Other: GUEDEL Airway; GUEDEL Airway of size '000,00,0,' and '1' will be used.
Group B; In Group B No oropharyngeal airway (GUEDEL) will be inserted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation	Oxygen saturation <92% will be considered as complication	Day 1
Stridor	The presence of noisy breathing occurring through obstructed airflow. We clinically measure it by auscultation of the nose, oropharynx, neck and chest.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
laryngospasm	The occurrence of a transient and reversible spasm of the vocal cords. We will evaluate laryngospasm by observing a high pitch inspiratory stridor followed by partial or complete airway obstruction.	Day 1

Collaborators and Investigators

• Sponsor: Aga Khan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Children; laryngeal mask airway; Oropharyngeal Airway; Deep Anaesthesia
• Other Study ID Numbers: 2021-5669-19713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No