Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide

The purpose of this study is to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

Study Overview

• Status: Completed
• Conditions: Adult Disease
• Intervention / Treatment: Device: laryngeal tube (VBM Medizintechnik)

Detailed Description

Background : The laryngeal tube airway (LT) is an extraglottic airway device with a proximal and distal conical cuff designed to secure a patient's airway during either spontaneous breathing or controlled ventilation. Application of this device with the use of N2O may be related to the ischemic change of the oropharyngeal mucosa. The objective of this study was to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

Methods : Seventy-five patients were studied with the use of LT size 4. N2O (66%) and isoflurane were used to maintain anesthesia. Initial intracuff pressure and volume were recorded for airway sealing during ventilation. Time-course changes of the intracuff pressure followed by recording every 10 min. If the intracuff pressure reached 100 cmH2O, the cuff was deflated to the initial intracuff pressure and the volume of deflated air and postoperative airway complications were recorded.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hatyai, Songkhla, Thailand, 90110
      • Songklanagarind Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with general anesthesia

Description

Inclusion Criteria:

• American Society of Anesthesiologist physical status I or II
• Undergoing elective orthopedic surgery and surgery of breast under general anesthesia with an expected duration of 60 min or more

Exclusion Criteria:

• Height was < 155 or >180 cm (for the use of laryngeal tube size 4)
• Body mass index ≥35 kg/m2
• Preexisting laryngotracheal disease
• Risk of pulmonary aspiration of gastric contents.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intracuff pressure N2O; measured intracuff pressure of LT with N2o during operative period	Device: laryngeal tube (VBM Medizintechnik); laryngeal tube number 4; Other Names: The laryngeal tube (VBM Medizintechnik, Sulz, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intracuff pressure	measured intracuff pressure of LT with N2O during intraoperative period	1-4 hours

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: April 25, 2011
• First Submitted That Met QC Criteria: May 2, 2011
• First Posted (ESTIMATE): May 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 5, 2011
• Last Update Submitted That Met QC Criteria: May 3, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: nitrous oxide; intracuff pressure; laryngeal tube
• Other Study ID Numbers: LT-N2O