PMID- 31394602
OWN - NLM
STAT- MEDLINE
DCOM- 20191108
LR  - 20191108
IS  - 1066-2936 (Print)
IS  - 1066-2936 (Linking)
VI  - 46
IP  - 3
DP  - 2019 BIMA Special Edition No. Feb
TI  - Adverse events and blinding in two randomized trials of hyperbaric oxygen for 
      persistent post-concussive symptoms.
PG  - 331-340
AB  - Safety monitoring and successful blinding are important features of randomized, 
      blinded clinical trials. We report chamber- and protocol-related adverse events 
      (AEs) for participants enrolled in two randomized, double-blind clinical trials 
      of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms 
      clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as 
      well as the success of maintaining the blind with a low-pressure sham control 
      arm. In both studies, participants were randomized to receive HBO2 (1.5 
      atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres 
      absolute, room air). In 143 participants undergoing 4,245 chamber sessions, 
      chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the 
      BIMA study). Minor, non-limiting barotrauma was the most frequently reported. 
      Rarely, some participants experienced headache with chamber sessions. No serious 
      adverse events were associated with chamber sessions. An allocation questionnaire 
      completed after intervention revealed that the sham control arm adequately 
      protected the blind in both trials. Participants based allocation assumptions on 
      symptom improvement or lack of symptom improvement and could not discern 
      intervention arm by pressure, smell, taste, or gas flow.
CI  - Copyright(c) Undersea and Hyperbaric Medical Society.
FAU - Churchill, Susan
AU  - Churchill S
AD  - Division of Hyperbaric Medicine, Intermountain Medical Center, Murray, Utah and 
      Intermountain LDS Hospital, Salt Lake City, Utah U.S.
FAU - Deru, Kayla
AU  - Deru K
AD  - Division of Hyperbaric Medicine, Intermountain Medical Center, Murray, Utah and 
      Intermountain LDS Hospital, Salt Lake City, Utah U.S.
FAU - Weaver, Lindell K
AU  - Weaver LK
AD  - Division of Hyperbaric Medicine, Intermountain Medical Center, Murray, Utah and 
      Intermountain LDS Hospital, Salt Lake City, Utah U.S.
AD  - Department of Medicine, University of Utah School of Medicine, Salt Lake City, 
      Utah U.S.
FAU - Wilson, Steffanie H
AU  - Wilson SH
AD  - Emmes, Rockville, Maryland U.S.
FAU - Hebert, Donald
AU  - Hebert D
AD  - Emmes, Rockville, Maryland U.S.
FAU - Miller, R Scott
AU  - Miller RS
AD  - The Gates Foundation, Seattle, Washington U.S.
FAU - Lindblad, Anne S
AU  - Lindblad AS
AD  - Emmes, Rockville, Maryland U.S.
LA  - eng
SI  - ClinicalTrials.gov/NCT01306968
SI  - ClinicalTrials.gov/NCT01611194
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Undersea Hyperb Med
JT  - Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical 
      Society, Inc
JID - 9312954
SB  - IM
MH  - Adult
MH  - Barotrauma/etiology
MH  - Brain Concussion/complications
MH  - Double-Blind Method
MH  - Earache/etiology
MH  - Female
MH  - Headache/etiology
MH  - Humans
MH  - Hyperbaric Oxygenation/*adverse effects/methods
MH  - Male
MH  - Military Personnel
MH  - Pilot Projects
MH  - Post-Concussion Syndrome/*therapy
MH  - Random Allocation
MH  - Safety
OTO - NOTNLM
OT  - adverse events
OT  - hyperbaric oxygenation
OT  - mild traumatic brain injury
OT  - post-concussive syndrome
OT  - safety
COIS- The authors of this paper declare no conflicts of interest exist with this 
      submission.
EDAT- 2019/08/09 06:00
MHDA- 2019/11/09 06:00
CRDT- 2019/08/09 06:00
PHST- 2019/08/09 06:00 [entrez]
PHST- 2019/08/09 06:00 [pubmed]
PHST- 2019/11/09 06:00 [medline]
PST - ppublish
SO  - Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):331-340.