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

April 5, 2016 updated by: Junyong In, MD, DongGuk University

Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggido
      • Goyang, Gyeonggido, Korea, Republic of, 10326
        • DongGuk University ilsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide
Time Frame: One hour after the exposure to nitrous oxide under general anesthesia
One hour after the exposure to nitrous oxide under general anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracuff pressure of the endotracheal tubes
Time Frame: 0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide
Intracuff pressures will be measured with a manometer (VBM, Sulz, Germany)
0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide
Postoperative sore throat: incidence
Time Frame: About 1, 6, 24 hours after termination of anesthesia
About 1, 6, 24 hours after termination of anesthesia
Postoperative hoarseness: incidence
Time Frame: About 1, 6, 24 hours after termination of anesthesia
About 1, 6, 24 hours after termination of anesthesia
Postoperative dysphagia: incidence
Time Frame: About 1, 6, 24 hours after termination of anesthesia
About 1, 6, 24 hours after termination of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DongGuk University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J In 2013-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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