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RecruitingNCT05218707Updated Mar 18, 2024

Oropharyngeal Airway and Airway Complications

An observational study in Airway Complication of Anesthesia, sponsored by Aga Khan University. Recruiting at 1 site in Pakistan. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Aga Khan University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
230
Ages
2 Years to 10 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Airway Complication of Anesthesia

Keywords

  • laryngeal mask airway
  • Oropharyngeal Airway
  • Deep Anaesthesia
  • Children
03

In context

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
230 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherGUEDEL Airway

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

06

What researchers measure

Primary outcomes

  1. Oxygen saturation

    Oxygen saturation \<92% will be considered as complication

    Time frame: Day 1

  2. Stridor

    The presence of noisy breathing occurring through obstructed airflow. We clinically measure it by auscultation of the nose, oropharynx, neck and chest.

    Time frame: Day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • Aga Khan University Hospital
    Karachi, Sindh 74800, Pakistan
    Recruiting
08

References and documents

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. PubMed 2100990 ↗
  • 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. PubMed 26086281 ↗
  • 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. PubMed 17040303 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05218707
Lead sponsor
Aga Khan University
Responsible party
Khalid Siddiqui (Assistant Professor, Aga Khan University) — Principal investigator
First posted
Feb 1, 2022
Start date
Feb 1, 2022
Primary completion
Nov 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Mar 18, 2024

Study contacts

Khalid Maudood Siddiqui, FCPS
Contact
khalid.siddiqui@aku.edu
+922134862896
Shemila Abbasi, FCPS
Contact
shemila.abbasi@aku.edu
+922134864632

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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