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Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy

Primary Purpose

Hyperbaric Oxygen Therapy, Middle Ear Barotrauma

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Self-acupressure therapy
Combined Valsalva and Toynbee maneuvers
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperbaric Oxygen Therapy focused on measuring Hyperbaric oxygen therapy, Middle ear barotrauma, Acupressure

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 20 years or order receiving the first HBOT
  • Alert consciousness

Exclusion Criteria:

  • Pregnancy
  • Having any acute disorder of the ears or upper respiratory tract
  • Having evidence of neurologic dysfunction precluding them from making an informed decision
  • Having a tracheostomy or endotracheal intubation
  • Having received a myringotomy, tympanoplasty, mastoidectomy or tympanostomy tube placement.

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Self-acupressure group

Control group

Arm Description

The subjects in experimental group will undergo additional self-acupressure therapy in addition to Valsalva and Toynbee maneuvers before the first HBOT. The acupoints used are TE17 (Yifeng, 翳風), TE21 (Ermen, 耳門), SI19 (Tinggong, 聽宮), GB2 (Tinghui, 聽會).

The subjects in control group will receive Valsalva and Toynbee maneuvers alone.

Outcomes

Primary Outcome Measures

Modified Teed Classification
The Modified Teed Classification, with grades from 0 to 5: Grade 0 indicates symptoms with no ontological signs of trauma; Grade 1 indicates injection of the tympanic membrane; Grade 2 indicates Grade 1 plus injection plus mild hemorrhage within the tympanic membrane; Grade 3 indicates gross hemorrhage within the tympanic membrane; Grade 4 indicates free blood in the middle ear as evidenced by blueness and bulging; and Grade 5 indicates perforation of the tympanic membrane.

Secondary Outcome Measures

Symptoms of MEB
Record the symptoms of MEB including feeling pressure in the ears, ear pain, headache, dizziness, vertigo, tinnitus and hearing loss. Each symptom is estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).
Overall ear discomfort levels
Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).

Full Information

First Posted
March 16, 2020
Last Updated
March 8, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04311437
Brief Title
Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy
Official Title
Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy: a Nonrandomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial 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
Middle ear barotrauma (MEB) is the most common complication during hyperbaric oxygen therapy (HBOT). Though Valsalva and Toynbee maneuvers have been proposed to prevent MEB, still some patients discontinue HBOT due to severe otalgia, hemorrhage or perforation of tympanic membrane associated with HBOT. Currently, there is no optimal prophylactic management for MEB associated with HBOT. The aim of this protocol is to investigate the efficacy of self-acupressure therapy on MEB associated with HBOT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbaric Oxygen Therapy, Middle Ear Barotrauma
Keywords
Hyperbaric oxygen therapy, Middle ear barotrauma, Acupressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-acupressure group
Arm Type
Experimental
Arm Description
The subjects in experimental group will undergo additional self-acupressure therapy in addition to Valsalva and Toynbee maneuvers before the first HBOT. The acupoints used are TE17 (Yifeng, 翳風), TE21 (Ermen, 耳門), SI19 (Tinggong, 聽宮), GB2 (Tinghui, 聽會).
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The subjects in control group will receive Valsalva and Toynbee maneuvers alone.
Intervention Type
Procedure
Intervention Name(s)
Self-acupressure therapy
Intervention Description
The self-acupressure therapy is as follows: Patients are in sitting position, applied firm pressure (3-5 kg of pressure) with the fingertips in a circular motion at a speed of two circles per second for a duration of one min per acupoint. A 1-2-s rest is applied after each ten circles. The complete process lasts for about 5 min.
Intervention Type
Procedure
Intervention Name(s)
Combined Valsalva and Toynbee maneuvers
Intervention Description
Valsalva maneuver: blowing against a closed mouth and nostrils, increasing the middle ear pressure. Toynbee maneuver: swallowing while the mouth and nostrils are closed, decreasing the middle ear pressure.
Primary Outcome Measure Information:
Title
Modified Teed Classification
Description
The Modified Teed Classification, with grades from 0 to 5: Grade 0 indicates symptoms with no ontological signs of trauma; Grade 1 indicates injection of the tympanic membrane; Grade 2 indicates Grade 1 plus injection plus mild hemorrhage within the tympanic membrane; Grade 3 indicates gross hemorrhage within the tympanic membrane; Grade 4 indicates free blood in the middle ear as evidenced by blueness and bulging; and Grade 5 indicates perforation of the tympanic membrane.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Symptoms of MEB
Description
Record the symptoms of MEB including feeling pressure in the ears, ear pain, headache, dizziness, vertigo, tinnitus and hearing loss. Each symptom is estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).
Time Frame
1 month
Title
Overall ear discomfort levels
Description
Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 20 years or order receiving the first HBOT Alert consciousness Exclusion Criteria: Pregnancy Having any acute disorder of the ears or upper respiratory tract Having evidence of neurologic dysfunction precluding them from making an informed decision Having a tracheostomy or endotracheal intubation Having received a myringotomy, tympanoplasty, mastoidectomy or tympanostomy tube placement.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Ting Liu, MD
Phone
+886-7-7317123
Ext
2334
Email
juntin0214@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu, MD
Organizational Affiliation
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu, MD
Phone
+886-7-7317123
Ext
2334
Email
juntin0214@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33907136
Citation
Chen JM, Lu ZN, Wu RW, Bi KW, Liu CT. Effect of self-acupressure on middle ear barotrauma associated with hyperbaric oxygen therapy: A nonrandomized clinical trial. Medicine (Baltimore). 2021 Apr 30;100(17):e25674. doi: 10.1097/MD.0000000000025674.
Results Reference
derived

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Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy

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