NCT03289767

Brief Summary

To observe the effect of additional E-tube angulation on intubation time and success rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2018

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

September 12, 2017

Last Update Submit

November 9, 2020

Conditions

Endotracheal Tube

Outcome Measures

Primary Outcomes (1)

  • Successful intubation on first attempt

    Whether successful intubation is done on first attempt or on additional attempt

    On endotracheal intubation up to 1 min

Secondary Outcomes (1)

  • Time to intubate (TIT)

    On endotracheal intubation up to 1 min

Study Arms (2)

Curved-tube

EXPERIMENTAL

Giving additional curve to the endotracheal tube by simple preparation.

Other: Curved-tube

Control

NO INTERVENTION

No other manipulation of the endotracheal tube is done.

Interventions

Curved-tubeOTHER

Connecting both ends of the endotracheal tube ("O" shape) for 5-min and releasing it provides additional anterior angle temporarily.

Curved-tube

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients scheduled for elective surgery requiring general anesthesia and tracheal intubation

You may not qualify if:

  • Patients with congenital or acquired upper airway lesions
  • Patients with high risk of aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

  • Jeong-Hwa Seo, PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 21, 2017

Study Start

December 5, 2017

Primary Completion

May 10, 2018

Study Completion

May 10, 2018

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

KR(1)