The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Pediatric Patients

NCT01435239 | Completed

• 1 other identifier: 1-2011-0046
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in children. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.

Conditions

Surgical Complications From General Anesthesia

Outcome Measures

Primary Outcomes (2)

• The intra-cuff pressure

  1\) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.

  approximately 5 to 10 minutes after insertion of LMA.

• The leak volume

  1\) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.

  approximately 5 to 10 minutes after insertion of LMA.

Study Arms (2)

resting volume group

EXPERIMENTAL

Device: The cuff inflation by the resting volume

maximum volume group

ACTIVE COMPARATOR

Device: The cuff inflation by the maximum volume

Interventions

The cuff inflation by the resting volume DEVICE

80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.

resting volume group

The cuff inflation by the maximum volume DEVICE

80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.

maximum volume group

Eligibility Criteria

• Age: Up to 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children (0-9 years of age)
• children who is scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using LMA-classic

You may not qualify if:

• patients with an abnormal airway
• patients with reactive airway disease
• patients with gastroesophageal reflux disease
• patients with chronic respiratory disease
• patients who has a history of an upper respiratory tract infection in the preceding 6-week period

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• Wallace CJ, Chambers NA, Erb TO, von Ungern-Sternberg BS. Pressure volume curves of paediatric laryngeal mask airways. Anaesthesia. 2009 May;64(5):527-31. doi: 10.1111/j.1365-2044.2008.05819.x.

  PMID: 19413823 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 16, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 6, 2014

Record last verified: 2014-03

Locations

KR (1)