NCT02165319

Brief Summary

To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

5 months

First QC Date

May 27, 2014

Last Update Submit

June 13, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • The cuff pressure after supine-to-lateral position change

    The cuff pressure will be measured after supine-to-lateral position change using the Manometer Portex®.

    At 10 minutes after anesthetic induction

Secondary Outcomes (2)

  • The distance from the tube to the carina

    At 10 minutes after anesthetic induction

  • Complications related to endotracheal tube

    At 0, 2, and 24 hours postoperatively

Study Arms (2)

Barrel

ACTIVE COMPARATOR

Endotracheal tube with barrel-shaped cuff will be used during general anesthesia.

Device: Barrel

Tapered

ACTIVE COMPARATOR

Endotracheal tube with tapered-shaped cuff will be used during general anesthesia.

Device: Tapered

Interventions

BarrelDEVICE

Barrel-shaped endotracheal tube will be used during general anesthesia.

Barrel
TaperedDEVICE

Tapered-shaped tube will be used during general anesthesia.

Tapered

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient scheduled for nephrectomy in lateral decubitus position

You may not qualify if:

  • Pregnancy
  • Patients with difficult airway
  • Patients with neck motion disorder
  • Patients with history of neck surgery
  • Patients with history of oral and pharyngeal surgery
  • Patients with body mass index \> 35
  • Patients without teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kim HC, Lee YH, Kim E, Oh EA, Jeon YT, Park HP. Comparison of the endotracheal tube cuff pressure between a tapered- versus a cylindrical-shaped cuff after changing from the supine to the lateral flank position. Can J Anaesth. 2015 Oct;62(10):1063-70. doi: 10.1007/s12630-015-0394-z. Epub 2015 Apr 17.

MeSH Terms

Conditions

PainPharyngitisHoarsenessCough

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVoice DisordersLaryngeal DiseasesRespiration DisordersNervous System DiseasesSigns and Symptoms, Respiratory

Study Officials

  • Hee-Pyoung Park, PhD

    Seoul National University of Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Chang Kim, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 17, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations