Topical Nasal Moisturization for Oxygen-Induced Nasal Dryness During Conventional Low-Flow Oxygen Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Patient-Reported Nasal Dryness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low-Flow Oxygen Alone
Participants received conventional low-flow oxygen therapy via nasal cannula without topical nasal moisturization.
干预措施: Conventional Low-Flow Oxygen Therapy (Other)
Low-Flow Oxygen Plus Isotonic Saline
Participants received conventional low-flow oxygen therapy plus topical nasal moisturization with 0.9% isotonic saline nasal drops.
干预措施: Conventional Low-Flow Oxygen Therapy (Other)
Low-Flow Oxygen Plus Isotonic Saline
Participants received conventional low-flow oxygen therapy plus topical nasal moisturization with 0.9% isotonic saline nasal drops.
干预措施: 0.9% Isotonic Saline Nasal Drops (Drug)
Low-Flow Oxygen Plus Hyaluronic Acid
Participants received conventional low-flow oxygen therapy plus topical nasal moisturization with a hyaluronic acid-based nasal spray.
干预措施: Conventional Low-Flow Oxygen Therapy (Other)
Low-Flow Oxygen Plus Hyaluronic Acid
Participants received conventional low-flow oxygen therapy plus topical nasal moisturization with a hyaluronic acid-based nasal spray.
干预措施: Hyaluronic Acid-Based Nasal Spray (Drug)
结局指标
主要结局
Patient-Reported Nasal Dryness
时间窗: At 4 hours (pre-intervention baseline) and 12 hours
Patient-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.
次要结局
- Patient Comfort(At 4 hours (pre-intervention baseline) and 12 hours)
- Patient-Reported Nasal Pain(At 4 hours (pre-intervention baseline) and 12 hours)
- Clinician-Assessed Nasal Mucosal Dryness(At 4 hours (pre-intervention baseline) and 12 hours)
- Intranasal Schirmer Test(At 4 hours (pre-intervention baseline) and 12 hours)
- Epistaxis(At 4 hours (pre-intervention baseline) and 12 hours)
研究者
Emrah Kinal
MD
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey