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Topical Nasal Moisturization for Oxygen-Related Nasal Dryness During Low-Flow Oxygen Therapy

Topical Nasal Moisturization for Oxygen-Induced Nasal Dryness During Conventional Low-Flow Oxygen Therapy: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07822451
Enrollment
150
Registered
2026-09-16
Start date
2026-07-29
Completion date
2026-08-30
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Dryness Associated With Low-Flow Oxygen Therapy

Keywords

Low-flow oxygen therapy, Nasal dryness, Nasal moisturization, Isotonic saline, Hyaluronic acid, Intranasal Schirmer test, Patient comfort

Brief summary

Conventional low-flow oxygen therapy delivered through a nasal cannula can cause nasal dryness and discomfort. This study evaluated whether topical nasal moisturization with 0.9% isotonic saline nasal drops or a hyaluronic acid-based nasal spray could reduce nasal dryness in adults receiving low-flow oxygen therapy. In this prospective, randomized, three-arm clinical trial, 150 adults receiving conventional low-flow nasal oxygen therapy in a coronary intensive care unit were assigned to one of three groups: low-flow oxygen alone, low-flow oxygen plus 0.9% isotonic saline nasal drops, or low-flow oxygen plus a hyaluronic acid-based nasal spray. All participants received low-flow oxygen alone during the first 4 hours. After the 4-hour assessment, the assigned topical nasal interventions were started and continued until the 12-hour assessment. The primary outcome was patient-reported nasal dryness. Other assessments included patient comfort, nasal pain, clinician-assessed nasal mucosal dryness, nasal moisture measured using the intranasal Schirmer test, and epistaxis. Outcomes were assessed at 4 and 12 hours.

Interventions

OTHERConventional Low-Flow Oxygen Therapy

Conventional low-flow oxygen therapy was administered via a standard nasal cannula according to the treating physician's clinical judgment and routine coronary intensive care practice.

DRUG0.9% Isotonic Saline Nasal Drops

Participants received topical nasal moisturization with 0.9% isotonic saline nasal drops in addition to conventional low-flow oxygen therapy. The nasal drops were administered after the 4-hour pre-intervention assessment and repeated at 7 and 10 hours. Final outcome assessment was performed at 12 hours.

DRUGHyaluronic Acid-Based Nasal Spray

Participants received topical nasal moisturization with a hyaluronic acid-based nasal spray (Hylonem®) containing sodium hyaluronate, sodium chloride, grapefruit seed extract, and purified water, in addition to conventional low-flow oxygen therapy. The nasal spray was administered after the 4-hour pre-intervention assessment. Final outcome assessment was performed at 12 hours.

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Participants were randomized in a 1:1:1 ratio to three parallel study groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults aged 18 years or older * Admission to the coronary intensive care unit * Receiving low-flow oxygen therapy via a standard nasal cannula * Expected to require oxygen therapy for at least 12 hours

Exclusion criteria

* Severe nasal septal deviation * Nasal polyps * Recent nasal surgery or trauma * Acute upper respiratory tract infection * Allergic rhinitis * Known hypersensitivity to isotonic saline or hyaluronic acid preparations

Design outcomes

Primary

MeasureTime frameDescription
Patient-Reported Nasal DrynessAt 4 hours (pre-intervention baseline) and 12 hoursPatient-reported nasal dryness was assessed using a 10-cm visual analog scale (VAS), where 0 indicates no nasal dryness and 10 indicates the worst imaginable nasal dryness. Nasal dryness was assessed at 4 hours, before initiation of the assigned topical nasal intervention, and again at 12 hours.

Secondary

MeasureTime frameDescription
Patient ComfortAt 4 hours (pre-intervention baseline) and 12 hoursPatient comfort was assessed using a 10-cm visual analog scale (VAS), where 0 indicates the worst possible comfort and 10 indicates the best possible comfort.
Patient-Reported Nasal PainAt 4 hours (pre-intervention baseline) and 12 hoursPatient-reported nasal pain was assessed using a 10-cm visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Clinician-Assessed Nasal Mucosal DrynessAt 4 hours (pre-intervention baseline) and 12 hoursNasal mucosal dryness was assessed by a clinician using a standardized four-point ordinal scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Intranasal Schirmer TestAt 4 hours (pre-intervention baseline) and 12 hoursNasal surface moisture was objectively assessed using the intranasal Schirmer test. Schirmer strips were placed intranasally, and the length of strip wetting was recorded in millimeters (mm), with higher values indicating greater nasal surface moisture.
EpistaxisAt 4 hours (pre-intervention baseline) and 12 hoursEpistaxis was assessed as the presence or absence of nasal bleeding at each assessment.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026