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

This study has been completed.
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01346384
First received: April 25, 2011
Last updated: May 3, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Adult Disease
Device: laryngeal tube (VBM Medizintechnik)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • intracuff pressure [ Time Frame: 1-4 hours ] [ Designated as safety issue: Yes ]
    measured intracuff pressure of LT with N2O during intraoperative period


Enrollment: 75
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
intracuff pressure N2O
measured intracuff pressure of LT with N2o during operative period
Device: laryngeal tube (VBM Medizintechnik)
laryngeal tube number 4
Other Name: The laryngeal tube (VBM Medizintechnik, Sulz, Germany)

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.

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with general anesthesia

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01346384

Locations
Thailand
Songklanagarind Hospital
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
  More Information

No publications provided

Responsible Party: Assistant Professor Nalinee Kovitwanawong, Department of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand
ClinicalTrials.gov Identifier: NCT01346384     History of Changes
Other Study ID Numbers: LT-N2O
Study First Received: April 25, 2011
Last Updated: May 3, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
intracuff pressure
laryngeal tube
nitrous oxide

Additional relevant MeSH terms:
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014