Hydrogenology
Hydrogenology editorial study record

Safety of prolonged inhalation of hydrogen gas in air in healthy adults

Cole AR, Sperotto F, DiNardo JA, Carlisle S, Rivkin MJ, Sleeper LA, Kheir JN. · Critical Care Explorations. 2021;3(10):e0543.

HumanInhaled H₂Published 2021
Study record, not medical adviceThis page reports one source and Hydrogenology’s source-text extraction. It does not establish that molecular hydrogen is effective, safe or appropriate for any person. Human, animal and laboratory evidence must not be treated as equivalent.
Source and classification

What kind of evidence is this?

Evidence stream

Human

Reported design

Prospective single-arm sequential-duration inpatient safety study

Research topic

Other molecular hydrogen research

Administration classification

Inhaled H₂

Study result signal

Not reported in this record.

Outcome type

Not reported in this record.

Reported in the source

Methods at a glance

Population or model

Healthy adults aged 18–30 years admitted for directly observed high-flow nasal-cannula exposure.

Sample

Eight participants completed exposure: n=2 for 24 hours, n=2 for 48 hours and n=4 for 72 hours; four were women and four men.

Duration

Continuous exposure for 24, 48 or 72 hours, followed by testing and telephone follow-up one day and three to five days later.

Intervention

Premixed 2.4% H₂ in medical air delivered continuously by heated, humidified high-flow nasal cannula at 15 L/min after a four-hour medical-air acclimatization period.

Hydrogen form

H₂ alone as the study gas diluted in medical air — not Brown's gas or oxyhydrogen.

H₂ specification

Certified premix containing 2.4% H₂ in 21% O₂, balance nitrogen; total delivered flow 15 L/min.

H₂ flow

360 mL/min H₂, calculated directly from the reported 15,000 mL/min total flow × 2.4% H₂.

O₂ delivered with H₂

3,150 mL/min O₂, calculated directly from 15,000 mL/min × the reported 21% O₂; O₂ was carrier medical air, not a Brown's-gas co-product.

Comparator

No concurrent control; participants had baseline testing and a four-hour 15 L/min medical-air period without H₂.

Reported, not endorsed

Outcomes and reported result

Outcomes measured

Symptoms and adverse events, vital signs, spirometry, ECG/telemetry, neurologic examination, Mini-Mental State Examination and hematologic, renal, hepatic, pancreatic and cardiac laboratory tests.

Reported result

No clinically significant adverse event or organ-injury signal was observed. FEV1, FVC, FEV1/FVC, neurologic scores and most laboratory measures were unchanged; small heart-rate, peak-flow, hemoglobin, hematocrit, platelet and chloride changes were judged clinically insignificant.

Results-extraction completeness

The complete free PMC article, protocol, tables, figures and disclosures were checked for gas composition and flow, duration cohorts, positive and null safety findings, limitations, funding and conflicts.

A reported association, difference or mechanism is not automatically a clinical benefit. Null findings, outcome type, study design and precision all matter.

Interpretation limits

Cautions and applicability

Design and reporting cautions

Only eight young healthy adults, single arm, no blinding and insufficient power to detect uncommon harms or establish safety in patients. Serum H₂ was not measured. The Pappendick Family award, Harvard Catalyst, NIH/NCATS and Harvard-affiliated institutions supported the work; authors disclosed no conflicts.

Applies directly to

Short phase-one-style tolerability evidence in healthy young adults at this exact mixture and high-flow protocol; it does not establish clinical benefit or safety in ill or older populations.

Preliminary appraisal framework

Not reported in this record.

Preliminary risk-of-bias status

Not reported in this record.

Appraisal rationale

Not reported in this record.

No single-study GRADE certainty rating is assigned. Certainty is assessed by important outcome across a complete eligible evidence set, not by attaching a final grade to one source.

Provenance

Sources and record status

Identifiers

PMID: 34651133 · DOI: 10.1097/CCE.0000000000000543

Publisher access

Free full article in PubMed Central.

Extraction basis

Complete PMC article and PubMed metadata; full-text extraction checked 9 August 2026.

Record revision

2026-08-10