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临床试验/NCT04332211
NCT04332211已完成4 期

Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
105
试验地点
1
主要终点
Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression

研究概览

简要总结

Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning. The most commonly associated complication of HBOT is middle ear barotrauma (MEB) which occurs when the eustachian tube does not allow air to enter the middle ear space to equalize the pressure between the ambient environment and the inner ear. Patients experiencing MEB usually feel pressure or pain in their ear(s). The spectrum of symptoms ranges from sensation of ear fullness and muffled hearing to severe pain, vertigo and tympanic membrane rupture. The incidence of MEB, depending on the definition used is between 2-45%. The severe discomfort associated with MEB sometimes causes HBOT to be postponed or abandoned. Last year 27/991 treatments at our Center for Hyperbaric and Dive Medicine were aborted due to MEB. Currently there is no objective criteria for predicting which patients will experience these complications, nor is there consensus on effective prevention measures. At our facility, oxymetazoline, a topical nasal decongestant, is the standard rescue medication administered for patients that have symptoms of MEB during HBOT. This is despite two negative studies showing that this medication does not work any better than placebo. Other studies involving scuba divers and airplane travelers showed that oral pseudoephedrine is effective in decreasing MEB. However, the use of pseudoephedrine for patients undergoing HBOT has not been studied. The investigators plan to perform a randomized double blind placebo control trial to determine if pseudoephedrine is effective in decreasing the rate of MEB during HBOT.

详细描述

Aim 1: To investigate the efficacy of pre-treatment with oral pseudoephedrine 60mg for decreasing MEB during HBOT.

Hypothesis

Patients randomized to pseudoephedrine will have a lesser need for oxymetazoline rescue therapy while being compressed. They will also report less ear pain once at pressure compared to patients receiving placebo.

Aim 2: To measure the incidence of MEB during HBOT. The investigators will also identify factors (age, gender, medical history) that could predispose an individual to developing MEB during HBOT.

Hypothesis

The incidence of MEB defined as requiring stopping compression of the chamber and oxymetazoline rescue will be greater than 30%. Female sex, age above 60, and prior history of ear conditions will be associated with development of MEB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

prospective randomized double-blind placebo control

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • New patient requiring HBOT (either inpatient or outpatient)
  • Age greater than or equal to 18 years and less than 80 years
  • Fluent in English
  • Full decision capacity
  • Able and medically cleared to swallow a pill

排除标准

  • Contraindication to pseudoephedrine (MAOI use, pregnancy, glaucoma, heart disease, allergy to drug class)
  • SBP >160
  • DBP > 90
  • Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
  • Intubated
  • Unable take PO meds

研究组 & 干预措施

Pseudoephedrine Group

Experimental

Patients randomized to pseudoephedrine prior to hyperbaric therapy

干预措施: Hyperbaric Oxygen Therapy (Procedure)

Pseudoephedrine Group

Experimental

Patients randomized to pseudoephedrine prior to hyperbaric therapy

干预措施: Pseudoephedrine 60 MG (Drug)

Placebo Group

Placebo Comparator

Patients randomized to placebo prior to hyperbaric therapy

干预措施: Hyperbaric Oxygen Therapy (Procedure)

Placebo Group

Placebo Comparator

Patients randomized to placebo prior to hyperbaric therapy

干预措施: Placebo oral tablet (Drug)

结局指标

主要结局

Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression

时间窗: 12 minutes

middle ear barotrauma will be sensed as pain and inability to "clear" the ear to pressure during chamber pressurization. If the patient requires rescue oxymetazoline nasal spray therapy (usual care) they will be counted as having developed middle ear barotrauma.

次要结局

  • Middle Ear Barotrauma Documentation Based on Otoscopy(1 minute)
  • Patient Description of Ear Pain(1 minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siamak Moayedi, MD

Assistant Professor

University of Maryland, Baltimore

研究点 (1)

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