Oropharyngeal Airway and Airway Complications

Airway Complication of Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218707
• Other study ID #: 2021-5669-19713
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Aga Khan University
• Contact: Khalid Maudood Siddiqui, FCPS
• Phone: +922134862896
• Email: khalid.siddiqui[@]aku.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Complication of Anesthesia

Intervention

Other:
• GUEDEL Airway
GUEDEL Airway of size '000,00,0,' and '1' will be used.

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation	Oxygen saturation <92% will be considered as complication	Day 1
Primary	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	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