Oropharyngeal Airway and Airway Complications

NCT ID: NCT05218707

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Airway Complication of Anesthesia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

GUEDEL Airway

Intervention Type OTHER

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

Group B

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

No interventions assigned to this group

Interventions

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GUEDEL Airway

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Khalid Siddiqui

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Khalid Maudood Siddiqui, FCPS

Role: CONTACT

+922134862896

Shemila Abbasi, FCPS

Role: CONTACT

+922134864632

Facility Contacts

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Khalid Maudood Siddiqui, FCPS

Role: primary

00922134862899 ext. 2899

References

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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.

Reference Type BACKGROUND
PMID: 2100990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26086281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17040303 (View on PubMed)

Other Identifiers

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2021-5669-19713

Identifier Type: -

Identifier Source: org_study_id

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