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

Sponsor
Prince of Songkla University (Other)
Overall Status
Completed
CT.gov ID
NCT01346384
Collaborator
(none)
75
Enrollment
1
Location
19
Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
75 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm 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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. intracuff pressure [1-4 hours]

      measured intracuff pressure of LT with N2O during intraoperative period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Songklanagarind Hospital Hatyai Songkhla Thailand 90110

    Sponsors and Collaborators

    • Prince of Songkla University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01346384
    Other Study ID Numbers:
    • LT-N2O
    First Posted:
    May 3, 2011
    Last Update Posted:
    May 5, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    intracuff pressure
    laryngeal tube
    nitrous oxide

    Study Results

    No Results Posted as of May 5, 2011