Trial Outcomes & Findings for Pulmonary Function After Hyperbaric Oxygen Therapy (NCT NCT05088772)
NCT ID: NCT05088772
Last Updated: 2024-05-16
Results Overview
Change from baseline FEV1% defined as the highest value selected from at least three satisfactory pulmonary function tests at each timepoint
Recruitment status
COMPLETED
Target enrollment
86 participants
Primary outcome timeframe
The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
Hyperbaric Oxygen Therapy - Experimental Group
Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference.
|
|---|---|
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Overall Study
STARTED
|
86
|
|
Overall Study
COMPLETED
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hyperbaric Oxygen Therapy - Experimental Group
n=86 Participants
Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=86 Participants
|
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Age, Categorical
Between 18 and 65 years
|
53 Participants
n=86 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=86 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 15.0 • n=86 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=86 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=86 Participants
|
|
Body Mass Index
|
27.1 kg/m*m
STANDARD_DEVIATION 10.3 • n=86 Participants
|
|
Comorbidities
|
123 total comorbidities
n=86 Participants
|
|
Medications
|
115 total medications
n=86 Participants
|
|
Smoking Status
Current Smoker
|
23 Participants
n=86 Participants
|
|
Smoking Status
Former Smoker
|
16 Participants
n=86 Participants
|
|
Smoking Status
Never Smoker
|
47 Participants
n=86 Participants
|
PRIMARY outcome
Timeframe: The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)Change from baseline FEV1% defined as the highest value selected from at least three satisfactory pulmonary function tests at each timepoint
Outcome measures
| Measure |
Hyperbaric Oxygen Therapy - Experimental Group
n=86 Participants
Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference.
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|---|---|
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Change in Percentage Predicted Forced Expiratory Volume in One Second (FEV1%)
40 Treatments
|
87.4 Percentage of FEV1
Interval 82.4 to 92.3
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Change in Percentage Predicted Forced Expiratory Volume in One Second (FEV1%)
60 Treatments
|
84.6 Percentage of FEV1
Interval 77.7 to 91.5
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Change in Percentage Predicted Forced Expiratory Volume in One Second (FEV1%)
Pre-HBOT
|
88.0 Percentage of FEV1
Interval 83.3 to 92.7
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Change in Percentage Predicted Forced Expiratory Volume in One Second (FEV1%)
20 Treatments
|
85.9 Percentage of FEV1
Interval 81.2 to 90.6
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PRIMARY outcome
Timeframe: The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)Change from baseline FVC% defined as the highest value selected from at least three satisfactory pulmonary function tests at each timepoint
Outcome measures
| Measure |
Hyperbaric Oxygen Therapy - Experimental Group
n=86 Participants
Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference.
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|---|---|
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Change in Percentage Predicted Forced Vital Capacity (FVC%)
Pre-HBOT
|
88.8 Percentage of FVC
Interval 83.7 to 94.0
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Change in Percentage Predicted Forced Vital Capacity (FVC%)
20 Treatments
|
86.9 Percentage of FVC
Interval 81.8 to 92.1
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Change in Percentage Predicted Forced Vital Capacity (FVC%)
40 Treatments
|
89.2 Percentage of FVC
Interval 83.8 to 94.5
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|
Change in Percentage Predicted Forced Vital Capacity (FVC%)
60 Treatments
|
85.9 Percentage of FVC
Interval 79.1 to 92.6
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PRIMARY outcome
Timeframe: The outcome measure was evaluated at baseline (pre-HBOT) and after four weeks (20 treatments), eight weeks (40 treatments), and twelve weeks (60 treatments)Change from baseline FEF25-75% defined as the highest value selected from at least three satisfactory pulmonary function tests at each timepoint
Outcome measures
| Measure |
Hyperbaric Oxygen Therapy - Experimental Group
n=86 Participants
Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference.
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|---|---|
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Change in Percentage Predicted Forced Mid-Expiratory Flow Rate (FEF25-75%)
Pre-HBOT
|
66.9 Percentage of FEF25-75
Interval 57.3 to 76.5
|
|
Change in Percentage Predicted Forced Mid-Expiratory Flow Rate (FEF25-75%)
20 Treatments
|
66.7 Percentage of FEF25-75
Interval 57.1 to 76.3
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Change in Percentage Predicted Forced Mid-Expiratory Flow Rate (FEF25-75%)
40 Treatments
|
66.2 Percentage of FEF25-75
Interval 56.4 to 76.0
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Change in Percentage Predicted Forced Mid-Expiratory Flow Rate (FEF25-75%)
60 Treatments
|
64.6 Percentage of FEF25-75
Interval 53.1 to 76.2
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SECONDARY outcome
Timeframe: From date of recruitment until the date of first documented pulmonary complication or most recent follow-up, whichever came first, assessed up to a maximum of 5 years from study recruitmentAny recorded pulmonary complications of HBOT, including but not limited to lung barotrauma, air embolism, and pneumothorax, identified through retrospective chart review
Outcome measures
| Measure |
Hyperbaric Oxygen Therapy - Experimental Group
n=86 Participants
Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference.
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|---|---|
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Pulmonary Complications Following Hyperbaric Oxygen Therapy
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0 Pulmonary Complications
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Adverse Events
Hyperbaric Oxygen Therapy - Experimental Group
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hyperbaric Oxygen Therapy - Experimental Group
n=86 participants at risk
Patients receiving hyperbaric oxygen therapy at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada)
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy performed at 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician preference.
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|---|---|
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Ear and labyrinth disorders
Ear Barotrauma
|
19.8%
17/86 • 5 years
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Nervous system disorders
Seizure
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2.3%
2/86 • 5 years
|
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Eye disorders
Ocular Changes
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18.6%
16/86 • 5 years
|
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Psychiatric disorders
Anxiety
|
20.9%
18/86 • 5 years
|
|
Cardiac disorders
Congestive Heart Failure
|
1.2%
1/86 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place