NCT04311437

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 10, 2022

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

March 16, 2020

Last Update Submit

March 8, 2022

Conditions

Hyperbaric Oxygen TherapyMiddle Ear Barotrauma

Keywords

Hyperbaric oxygen therapyMiddle ear barotraumaAcupressure

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (2)

  • Symptoms of MEB

    1 month

  • Overall ear discomfort levels

    1 month

Study Arms (2)

Self-acupressure group

EXPERIMENTAL

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).

Procedure: Self-acupressure therapyProcedure: Combined Valsalva and Toynbee maneuvers

Control group

PLACEBO COMPARATOR

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

Procedure: Combined Valsalva and Toynbee maneuvers

Interventions

Self-acupressure therapyPROCEDURE

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.

Self-acupressure group
Combined Valsalva and Toynbee maneuversPROCEDURE

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.

Control groupSelf-acupressure group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33907136DERIVED

Study Officials

  • Chun-Ting Liu, MD

    Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Ting Liu, MD

CONTACT

+886-7-7317123juntin0214@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 17, 2020

Study Start

March 1, 2020

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 10, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)