Anesthesia With Endotracheal Laser Tube

An observational study of Anesthesia and Anesthesia Morbidity, run by University of Pecs at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study examines the special endotracheal laser tube during anesthesia of endolaryngeal laser surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anesthesia, Anesthesia Morbidity
What is being tested?: Application of ET laser tube in propofol anesthesia
Type of treatment: Injection or infusion
How many people: 30 participants
Where: 1 siteHungary
Study dates: 1 Jan 2017to 16 Jun 2017
How long will I take part?: 5 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patient with endolaryngeal laser surgery and after 18 years

Who may be able to join

laser surgery

Who cannot join

allergy of propofol

Trial locations and contacts

1 site in 1 country.

Hungary1 site

PTE Department of ENT
Pécs

Other trials in Hungary

About this study

Official title: Anesthesia of Endolaryngeal Surgery With a Special Endotracheal Laser Tube

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

Read the detailed description

The special endotracheal tube is covered by a special aluminum tape.

Conditions: Anesthesia, Anesthesia Morbidity
Being tested: Application of ET laser tube in propofol anesthesia
Keywords: laser, endotracheal tube, total intravenous anesthesia, side effect, endolaryngeal surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03044418
Study group	Role	What they receive
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. Receives: Other: Application of ET laser tube in propofol anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Side Effects
problem with airway or special laser tube
Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201716 Jun 2017

First posted7 Feb 2017 (estimated)
Study start1 Jan 2017
Primary completion5 Jun 2017
Study completion16 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnesthesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 30 participants (actual)
Target duration: 5 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT03044418
Sponsor's protocol ID: 6419
Status last verified: Aug 2021
First submitted: 29 Jan 2017
Last updated: 20 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anesthesia of Endolaryngeal Surgery With a Special Endotracheal Laser Tube
ClinicalTrials.gov ID: NCT03044418
Acronym / sponsor ID: 6419
Conditions: Anesthesia, Anesthesia Morbidity
Keywords: laser, endotracheal tube, total intravenous anesthesia, side effect, endolaryngeal surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of PecsUniversity, hospital or other
Study start: 1 Jan 2017 (actual)
Primary completion: 5 Jun 2017 (actual)
Study completion: 16 Jun 2017 (actual)
First posted: 7 Feb 2017 (estimated)
Results: Posted 20 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The special endotracheal tube is covered by a special aluminum tape.

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 5 Months
Number of arms: 1

Arm	Type	Receives
anesthesia with laser tube	–	Other: Application of ET laser tube in propofol anesthesiaThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patient with endolaryngeal laser surgery and after 18 years

Key inclusion criteria (1 listed)

laser surgery

Key exclusion criteria (1 listed)

allergy of propofol

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Application of ET laser tube in propofol anesthesiaThe special ET laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.	Other	anesthesia with laser tube

Primary outcome

Number of Participants With Side Effects
Time frame: 5 months
problem with airway or special laser tube

Results and safety

Results posted to the registry on 20 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anesthesia With Special ET Laser Tube	30	30

Primary outcome: Number of Participants With Side Effects

Time frame: 5 months. Number. Unit: participants

Measure	Anesthesia With Laser Tube n = 30
Value	0

Adverse events

Time frame: 6 months; between January 2017 and June 2017 during our study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The Frequency of Side Effects of Special ET Laser Tube Using	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): The special laser tube is used only for less than one hour

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lajos Bogar, MedHabil study chair

PTE Department of the Anesthesiology and Intensive Therapy

Laszlo Lujber, PhD study chair

PTE Department of ENT

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia and Anesthesia Morbidity, run by University of Pecs at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Side Effects (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03044418.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.