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

NCT ID: NCT04311437

Last Updated: 2022-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperbaric Oxygen Therapy Middle Ear Barotrauma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Self-acupressure group

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).

Group Type EXPERIMENTAL

Self-acupressure therapy

Intervention Type PROCEDURE

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.

Combined Valsalva and Toynbee maneuvers

Intervention Type PROCEDURE

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 group

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

Group Type PLACEBO_COMPARATOR

Combined Valsalva and Toynbee maneuvers

Intervention Type PROCEDURE

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.

Interventions

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Self-acupressure therapy

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

Combined Valsalva and Toynbee maneuvers

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun-Ting Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chun-Ting Liu, MD

Role: CONTACT

+886-7-7317123 ext. 2334

Facility Contacts

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Chun-Ting Liu, MD

Role: primary

+886-7-7317123 ext. 2334

References

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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.

Reference Type DERIVED
PMID: 33907136 (View on PubMed)

Other Identifiers

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CMRPG8K0461

Identifier Type: -

Identifier Source: org_study_id

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