NCT03044418

Brief Summary

The study examines the special endotracheal laser tube during anesthesia of endolaryngeal laser surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

September 20, 2021

Completed
Last Updated

September 20, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

January 29, 2017

Results QC Date

June 20, 2017

Last Update Submit

August 24, 2021

Conditions

AnesthesiaAnesthesia Morbidity

Keywords

laserendotracheal tubetotal intravenous anesthesiaside effectendolaryngeal surgery

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Side Effects

    problem with airway or special laser tube

    5 months

Study Arms (1)

anesthesia with laser tube

The special endotracheal (ET) laser tube is tested during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We tested the application of ET laser tube in propofol anesthesia.

Other: Application of ET laser tube in propofol anesthesia

Interventions

Application of ET laser tube in propofol anesthesiaOTHER

The special ET laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.

anesthesia with laser tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with endolaryngeal laser surgery and after 18 years

You may qualify if:

  • laser surgery

You may not qualify if:

  • allergy of propofol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PTE Department of ENT

Pécs, Hungary

Location

Limitations and Caveats

The special laser tube is used only for less than one hour

Results Point of Contact

Title
Dr. Timea Bocskai
Organization
University of Pecs
timokeri@gmail.com
+36 72 507374

Study Officials

  • Lajos Bogar, MedHabil

    PTE Department of the Anesthesiology and Intensive Therapy

    STUDY CHAIR

  • Laszlo Lujber, PhD

    PTE Department of ENT

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2017

First Posted

February 7, 2017

Study Start

January 1, 2017

Primary Completion

June 5, 2017

Study Completion

June 16, 2017

Last Updated

September 20, 2021

Results First Posted

September 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)