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Emerging Indications for Hyperbaric Oxygen Treatment

ConditionsPost-COVID-19 ConditionUlcerative ColitisCrohn DiseaseCalciphylaxisFrostbiteAcute COVID-19Pyoderma GangrenosumPterygiumHypospadiasHead TraumaPneumatosis IntestinalisIschemic BowelRaynaud SyndromeMalignant Otitis ExternaNonarteritic Anterior Ischemic Optic NeuropathyCentral Retinal Vein OcclusionFemoral Head NecrosisInvasive Fungal InfectionChronic Anal FissureVasculitic UlcerGraft-vs-Host DiseaseDecubitus UlcerGreater Trochanteric Pain SyndromeRectovaginal FistulaPouchitisTinnitusClostridium EnterocolitisBranch Retinal Artery OcclusionAxonotmesisMultiple SclerosisInclusion Body MyositisEpidermolysis Bullosa (EB)OsteonecrosisUlcer IschemicAvascular Necrosis of BoneProsthesis Related InfectionsFacial Filler InjectionsCystitis ChronicLigament InjuryAnastomosis, LeakingCartilage Injury
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJay C. Buckey Jr.

About this trial

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients referred for HBOT with an emerging indication

Disqualifiers

Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)

Pregnant persons

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperbaric oxygen treatment (HBOT)

    Device

    Hyperbaric oxygen refers to oxygen given at pressures higher than atmospheric pressure (higher than 1.4 ATA) in pressurized chamber.

  • 100% Oxygen

    Drug

    Receiving 100% oxygen as part of HBOT

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Hyperbaric oxygen treated groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Quality of Life EuroQOL EQ-5D-5L Questionnaire

Every individual has quality of life measured using the EuroQol EQ-5D-5L measure. The measure has 5 scales (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression), that each have 5 levels (none, slight, moderate, severe, unable). The scores are calculated using the procedures outlined in the EuroQOL handbook to create a final score on a 0-1 scale. There is also an overall visual analog scale that asks about perceived health on a 0-100 scale. Higher scores indicate better quality of life. Data are aggregated in the Multicenter Registry for Hyperbaric Oxygen Treatment.

Time frame
Within one week of starting HBO2 and within one week of ending HBO2 treatment

Secondary outcomes

1

Urogenital Distress Inventory

Patients with cystitis will complete the Urinogential Distress Inventory (UDI). The six questions ask about symptoms on a 4 point scale (No= 0, Not at all= 1, Somewhat= 2, Moderately= 3, Quite a bit= 4). The UDI scaled score is calculated by adding all scores and multiplying by 6 and then multiply by 25 for the scale score. Missing items are dealt with by using the mean from the answered items only. Higher score = higher disability.

Time frame
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
2

Bowel symptoms questionnaire

Those with conditions affecting the gastrointestinal tract will complete the bowel symptoms questionnaire. The questionnaire has nine questions that cover the areas of frequency, blood, pain, and urgency. Severity is rated on a 4 point scale from 0 to 4 with 4 being severe. Higher values indicate more symptoms.

Time frame
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
3

Head and Neck Questionnaire

The head and neck questionnaire has 37 questions selected from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H\&N35 and the Groningen Radiotherapy-Induced Xerostomia (GRIX) questionnaire. The questionnaire covers dry mouth, pain, and difficulties with smell and taste. The scores are converted to a 0-100 scale with higher numbers indicating more symptoms.

Time frame
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments
4

Perianal Crohn's Symptom Index Questionnaire

The perianal Crohn's symptom index has 13 questions that cover fistulas, fistula discharge, rectal discharge, bowel frequency, urgency, blood, and pain. The answers are converted to an overall summed score with higher levels indicating more symptoms.

Time frame
Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jay C. Buckey Jr.

Lead sponsor

Dartmouth-Hitchcock Medical Center

Sponsor institution

Dartmouth College

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: