NCT02359630

Brief Summary

Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2005

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

Study Start

First participant enrolled

January 1, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

2.1 years

First QC Date

January 18, 2015

Last Update Submit

May 8, 2017

Conditions

Airway Morbidity

Outcome Measures

Primary Outcomes (1)

  • success of insertion

    success of insertion

    60 seconds

Secondary Outcomes (5)

  • duration of ventilation

    60 seconds

  • inspiratory and expiratory minute volumes

    60 seconds

  • oropharyngeal leak pressure

    60 seconds

  • rate of complications

    60 seconds

  • rating of insertion difficulty

    60 seconds

Study Arms (2)

EasyTube

ACTIVE COMPARATOR

Use of EasyTube during general anesthesia

Device: EasyTubeDevice: Endotracheal tube

Endotracheal tube

EXPERIMENTAL

Use of endotrachel tube during general anesthesia

Device: EasyTubeDevice: Endotracheal tube

Interventions

EasyTubeDEVICE

Insertion for ventilation

EasyTubeEndotracheal tube
Endotracheal tubeDEVICE

Insertion for ventilation

EasyTubeEndotracheal tube

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I or II and were scheduled for an elective surgery requiring general anesthesia

You may not qualify if:

  • Age \< 18 years
  • Acute or chronic lung disease
  • Patients presenting with sore throat
  • Known esophageal disease
  • Oropharyngeal abnormalities
  • Patients with a cervical spine disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gaitini LA, Vaida SJ, Mostafa S, Yanovski B, Croitoru M, Capdevila MD, Sabo E, Ben-David B, Benumof J. The Combitube in elective surgery: a report of 200 cases. Anesthesiology. 2001 Jan;94(1):79-82. doi: 10.1097/00000542-200101000-00016.

    PMID: 11135725RESULT

Study Officials

  • Michael Frass, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 18, 2015

First Posted

February 10, 2015

Study Start

January 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

May 9, 2017

Record last verified: 2017-05