NCT01812915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.1 years

First QC Date

March 14, 2013

Last Update Submit

April 5, 2016

Conditions

Adverse Effect of Other General AnestheticsAnesthesia Intubation ComplicationInhalation of Nitrous OxideTrachea

Keywords

Cuff pressureCylindrical cuffEndotracheal tubeNitrous oxideTapered cuff

Outcome Measures

Primary Outcomes (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 Outcomes (4)

  • Intracuff pressure of the endotracheal tubes

    0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide

  • Postoperative sore throat: incidence

    About 1, 6, 24 hours after termination of anesthesia

  • Postoperative hoarseness: incidence

    About 1, 6, 24 hours after termination of anesthesia

  • Postoperative dysphagia: incidence

    About 1, 6, 24 hours after termination of anesthesia

Study Arms (2)

Cylindrical-shape cuff ETT (Group C)

EXPERIMENTAL

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)

Tapered-shape cuff ETT (Group T)

EXPERIMENTAL

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)

Interventions

Cylindrical-shape cuff ETT (Group C)DEVICE

Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt Hi-Lo(TM) endotracheal tube.

Also known as: Mallinckrodt Hi-Lo(TM) endotracheal tube
Cylindrical-shape cuff ETT (Group C)
Tapered-shape cuff ETT (Group T)DEVICE

Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt TaperGuard(TM) endotracheal tube.

Also known as: Mallinckrodt TaperGuard(TM) endotracheal tube
Tapered-shape cuff ETT (Group T)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo general anesthesia in a supine position with a neutral position of the head (hand and forearm sugery)
  • \~70 years old
  • American society of anesthesiologists physical status 1-2
  • Body mass index \< 30 kg/m2

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang, Gyeonggido, 10326, South Korea

Location

Related Publications (1)

  • Tsuboi S, Miyashita T, Yamaguchi Y, Yamamoto Y, Sakamaki K, Goto T. The TaperGuard endotracheal tube intracuff pressure increase is less than that of the Hi-Lo tube during nitrous oxide exposure: a model trachea study. Anesth Analg. 2013 Mar;116(3):609-12. doi: 10.1213/ANE.0b013e318279b399. Epub 2013 Feb 11.

    PMID: 23400983BACKGROUND

MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Junyong In, M.D., Ph.D.

    DongGuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 18, 2013

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

April 7, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)