Oropharyngeal Airway and Airway Complications

NCT05218707 | Recruiting

• 1 other identifier: 2021-5669-19713
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Complication of Anesthesia

Keywords

laryngeal mask airway; Oropharyngeal Airway; Deep Anaesthesia; Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• laryngospasm

  Day 1

Study Arms (2)

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

Group B

In Group B No oropharyngeal airway (GUEDEL) will be inserted.

Interventions

GUEDEL Airway OTHER

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

Group A

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related 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.

  PMID: 2100990 BACKGROUND

• 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.

  PMID: 26086281 BACKGROUND

• 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.

  PMID: 17040303 BACKGROUND

Central Study Contacts

Khalid Maudood Siddiqui, FCPS

CONTACT

+922134862896; khalid.siddiqui@aku.edu

Shemila Abbasi, FCPS

CONTACT

+922134864632; shemila.abbasi@aku.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 1, 2022
• Study Start: February 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

PA (1)