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Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia

Primary Purpose

Spontaneous Breathing, Laryngomicrosurgery, Superior Laryngeal Nerve Block

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Non-intubated Laryngomicrosurgery
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spontaneous Breathing focused on measuring Nonintubated, Spontaneous breathing, Laryngomicrosurgery, Superior laryngeal nerve block

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient who needed to undergo LMS.

Exclusion Criteria:

  • Severe airway obstruction.
  • Severe airway disease.
  • American Society of anesthesiologists (ASA) physical state > III.
  • Pregnancy or body mass index (BMI) ≥ 40 kg/m2.

Sites / Locations

  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Intubated general anesthesia LMS

Non-intubated LMS with apnea

Non-intubated LMS with spontaneous breathing

Arm Description

Patients received LMS with intubated general anesthesia

Patients received non-intubated LMS with administration of muscle relaxant and optiflow(HFNO) device.

Patients received non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing.

Outcomes

Primary Outcome Measures

PaCO2 after Laryngomicrosurgery
ABG was measured immediately after the end of LMS

Secondary Outcome Measures

pH after Laryngomicrosurgery
ABG was measured immediately after the end of LMS
Heart rate (HR)
Hemodynamic data were measured every 5 minutes

Full Information

First Posted
May 3, 2022
Last Updated
July 4, 2022
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT05420649
Brief Title
Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia
Official Title
Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia With Combination of Superior Laryngeal Nerve Block
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
March 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Nonintubated anesthesia applied in combination with high-flow nasal oxygen (HFNO) is an alternative strategy for laryngeal microsurgery (LMS). LMS is a common procedure in otolaryngology that typically requires endotracheal tube intubation under general anesthesia. Endotracheal tube intubation causes complications; a nonintubated strategy can avoid these complications and provide a clearer surgical field of vision, enabling vocal cord inspection and disposal. Administering a muscle relaxant can also help prevent bucking during surgery but can engender apnea and hypercapnia, which may have negative effects on hemodynamics. Therefore, the investigators assessed the effectiveness of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia in maintaining spontaneous breathing and improving safety during LMS with nonintubated anesthesia.
Detailed Description
Laryngeal microsurgery (LMS) is among the most common operations in otolaryngology and typically requires general anesthesia administered through endotracheal tube intubation. Endotracheal tube intubation provides stable gas exchange, protects the airways by preventing secretions from falling into the lower respiratory tract, and enables the monitoring of parameters such as tidal volume and end-tidal CO2. Nonintubated anesthesia applied in combination with transnasal humidified rapid-insufflation ventilatory exchange or high-flow nasal oxygen (HFNO) is another option for LMS. LMS with nonintubated anesthesia can avoid the complications caused by endotracheal tube intubation such as oral tissue trauma, tracheal trauma, and dental injury. Furthermore, LMS with nonintubated anesthesia can provide a clearer surgical field of vision that allows the vocal cords to be inspected and disposed of completely. Current practice in LMS with nonintubated anesthesia is to administer a muscle relaxant to help avoid bucking during the procedure. However, the administration of a muscle relaxant can lead to apnea and hypercapnia, which may negatively affect hemodynamics. Therefore, the investigators investigated the use of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia to help the patient maintain spontaneous breathing and provide higher surgical safety during LMS with nonintubated anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Breathing, Laryngomicrosurgery, Superior Laryngeal Nerve Block
Keywords
Nonintubated, Spontaneous breathing, Laryngomicrosurgery, Superior laryngeal nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intubated general anesthesia LMS
Arm Type
No Intervention
Arm Description
Patients received LMS with intubated general anesthesia
Arm Title
Non-intubated LMS with apnea
Arm Type
Experimental
Arm Description
Patients received non-intubated LMS with administration of muscle relaxant and optiflow(HFNO) device.
Arm Title
Non-intubated LMS with spontaneous breathing
Arm Type
Experimental
Arm Description
Patients received non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing.
Intervention Type
Procedure
Intervention Name(s)
Non-intubated Laryngomicrosurgery
Intervention Description
Non-intubated LMS was performed with assistance of Optiflow (HFNO).
Primary Outcome Measure Information:
Title
PaCO2 after Laryngomicrosurgery
Description
ABG was measured immediately after the end of LMS
Time Frame
ABG was measured immediately after the end of LMS
Secondary Outcome Measure Information:
Title
pH after Laryngomicrosurgery
Description
ABG was measured immediately after the end of LMS
Time Frame
ABG was measured immediately after the end of LMS
Title
Heart rate (HR)
Description
Hemodynamic data were measured every 5 minutes
Time Frame
during the LMS procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient who needed to undergo LMS. Exclusion Criteria: Severe airway obstruction. Severe airway disease. American Society of anesthesiologists (ASA) physical state > III. Pregnancy or body mass index (BMI) ≥ 40 kg/m2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Yi Chia, Director
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yu Ting Kuo, physician
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ting Shou Chang, physician
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chih Chi Tsai, RA
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Li-Ya Tseng, physician
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pei-Wen Shen, physician
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Director
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan

12. IPD Sharing Statement

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Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia

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