Clincosm LogoSign in Get a demo

Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide

Sponsor
DongGuk University (Other)
Overall Status
Completed
CT.gov ID
NCT01812915
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
14.9
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff hyperinflation of the endotracheal tube. Furthermore the difference among various types of cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.

TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical study is needed to evaluate the intracuff pressure during general anesthesia with nitrous oxide exposure.

Condition or Disease Intervention/Treatment Phase
  • Device: Cylindrical-shape cuff ETT (Group C)
  • Device: Tapered-shape cuff ETT (Group T)
 N/A

Detailed Description

During 60 minutes after routine anesthetic induction and intubation of the endotracheal tubes, intracuff pressures will be measured every 10 minutes with a manometer (VBM, Sulz, Germany).

60% nitrous oxide will be added at time 0. For 60 minutes from the beginning of general anesthesia, intracuff pressures will be measured every 10 minutes.

After 60 minutes, Intracuff pressures will be maintained around 20 cm H2O during the remaining period of the surgery.

The questionnaire for a sore throat, hoarseness, and dysphagia will be questioned at about 1, 6, and 24 hours after the surgery and the general anesthesia.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Official Title:
Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cylindrical-shape cuff ETT (Group C)

Control group: Mallinckrodt HiLo(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt Hi-Lo(TM) tube.

Device: Cylindrical-shape cuff ETT (Group C)
Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt Hi-Lo(TM) endotracheal tube.
Other Names:
  • Mallinckrodt Hi-Lo(TM) endotracheal tube

    		•
    Experimental: Tapered-shape cuff ETT (Group T)

    Experimental group: Mallinckrodt TaperGuard(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt TaperGuard(TM) tube.

    Device: Tapered-shape cuff ETT (Group T)
    Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt TaperGuard(TM) endotracheal tube.
    Other Names:
  • Mallinckrodt TaperGuard(TM) endotracheal tube

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide [One hour after the exposure to nitrous oxide under general anesthesia]

    Secondary Outcome Measures

    1. Intracuff pressure of the endotracheal tubes [0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide]

      Intracuff pressures will be measured with a manometer (VBM, Sulz, Germany)

    2. Postoperative sore throat: incidence [About 1, 6, 24 hours after termination of anesthesia]

    3. Postoperative hoarseness: incidence [About 1, 6, 24 hours after termination of anesthesia]

    4. Postoperative dysphagia: incidence [About 1, 6, 24 hours after termination of anesthesia]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who will undergo general anesthesia in a supine position with a neutral position of the head (hand and forearm sugery)

    • 18~70 years old

    • American society of anesthesiologists physical status 1-2

    • Body mass index < 30 kg/m2

    Exclusion Criteria:

    • Contraindication for nitrous oxide

    • Difficult intubation

    • Cormack-Lehane grade > 3

    • Airway-related or pulmonary diseases

    • Short or long operation time (< 1 hour or > 3 hours)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dongguk University Ilsan Hospital Goyang Gyeonggido Korea, Republic of 10326

    Sponsors and Collaborators

    • DongGuk University

    Investigators

    • Principal Investigator: Junyong In, M.D., Ph.D., DongGuk University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Junyong In, MD, Associate Professor, DongGuk University
    ClinicalTrials.gov Identifier:
    NCT01812915
    Other Study ID Numbers:
    • J In 2013-1
    First Posted:
    Mar 18, 2013
    Last Update Posted:
    Apr 7, 2016
    Last Verified:
    Apr 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Junyong In, MD, Associate Professor, DongGuk University
    Cuff pressure
    Cylindrical cuff
    Endotracheal tube
    Nitrous oxide
    Tapered cuff
    Additional relevant MeSH terms:
    Respiratory Aspiration

    Study Results

    No Results Posted as of Apr 7, 2016