Anesthesia With Endotracheal Laser Tube

• Sponsor: University of Pecs (Other)
• Overall Status: Completed
• CT.gov ID: NCT03044418
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Anesthesia Morbidity	Other: Application of ET laser tube in propofol anesthesia

Detailed Description

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

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Anesthesia of Endolaryngeal Surgery With a Special Endotracheal Laser Tube
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jun 5, 2017
• Actual Study Completion Date: Jun 16, 2017

Arms and Interventions

Arm	Intervention/Treatment
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; The special ET laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Side Effects [5 months]

   problem with airway or special laser tube

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• laser surgery

Exclusion Criteria:

• allergy of propofol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PTE Department of ENT	Pecs		Hungary

Sponsors and Collaborators

• University of Pecs

Investigators

• Study Chair: Lajos Bogar, MedHabil, PTE Department of the Anesthesiology and Intensive Therapy
• Study Chair: Laszlo Lujber, PhD, PTE Department of ENT

Study Documents (Full-Text)

• Study Protocol - Dec 6, 2016

More Information

Publications

None provided.

• Responsible Party: Timea Bocskai, Principal Investigator, University of Pecs
• ClinicalTrials.gov Identifier: NCT03044418
• Other Study ID Numbers: 6419
• First Posted: Feb 7, 2017
• Last Update Posted: Sep 20, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Timea Bocskai, Principal Investigator, University of Pecs: laser; endotracheal tube; total intravenous anesthesia; side effect; endolaryngeal surgery
• Additional relevant MeSH terms: Propofol

Study Results

Participant Flow

Arm/Group Title	Anesthesia With Special ET Laser Tube
Arm/Group Description	The special ET laser tube is tested during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We test the application of ET laser tube in propofol anesthesia. The special endotracheal laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	The Side Effects of Anesthesia With Special ET Laser Tube
Arm/Group Description	The frequency of side effects of anesthesia with a special ET laser tube is tested during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We test the application of ET laser tube in propofol anesthesia. The special endotracheal laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	12 40%
Male	18 60%
Race/Ethnicity, Customized (participants) [Number]
European	30 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Side Effects
Description	problem with airway or special laser tube
Time Frame	5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anesthesia With Laser Tube
Arm/Group Description	the side effects of anesthesia with a special ET laser tube
Measure Participants	30
Number [participants]	0 0%

Adverse Events

Time Frame	6 months; between January 2017 and June 2017 during our study
Arm/Group Title	The Frequency of Side Effects of Special ET Laser Tube Using
Arm/Group Description	The frequency of side effects of anesthesia with special ET laser tube are analysed during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We tested the application of ET laser tube in propofol anesthesia. The special endotracheal laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.
All Cause Mortality
	The Frequency of Side Effects of Special ET Laser Tube Using
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	The Frequency of Side Effects of Special ET Laser Tube Using
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	The Frequency of Side Effects of Special ET Laser Tube Using
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.