Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations: A Randomized Clinical Trial (KET-AIR Trial)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in Peak Expiratory Flow Rate (PEFR) from baseline to 60 minutes post-intervention
研究概览
简要总结
The goal of this clinical trial is to learn if nebulized ketamine helps treat moderate to severe asthma attacks in adults in the emergency department. It will also learn about the safety of ketamine when inhaled through a nebulizer.
The main questions it aims to answer are:
- Does nebulized ketamine improve breathing more than standard treatment alone?
- What side effects, if any, do participants experience after receiving nebulized ketamine?
Researchers will compare nebulized ketamine to a placebo (a saltwater mist with no medication) to see how well it works and how safe it is.
Participants will:
- Receive either nebulized ketamine or a placebo mist, along with standard asthma treatment
- Have their breathing checked before and after treatment using a peak flow meter
- Be monitored for 60 minutes and have their symptoms, vital signs, and any side effects recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study uses a double-blind design where all key parties are masked: participants, care providers (administering the nebulization), investigators (overseeing clinical care), and outcomes assessors (recording PEFR and symptom scores). Nebulized ketamine and placebo are prepared in identical-appearing formulations (5 mL clear solution in a nebulizer chamber) to maintain blinding. Randomization codes are securely stored and revealed only after data collection is complete. This design minimizes bias in treatment administration, symptom reporting, and outcome measurement
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 presenting to the Emergency Department with a clinical diagnosis of moderate to severe asthma exacerbation based on SIGN (Scottish Intercollegiate Guidelines Network) criteria.
- •PEFR between 33% and 75% of predicted value or personal best, as measured using a peak flow meter.
- •Stable vital signs as deemed by the treating physician
- •Alert and oriented, able to understand the study purpose and provide informed consent.
- •Not requiring immediate advanced airway intervention, including intubation or emergency non-invasive ventilation.
排除标准
- •Known hypersensitivity or allergy to ketamine or any component of the nebulized solution.
- •History of psychosis, schizophrenia, or other severe uncontrolled psychiatric disorders.
- •Uncontrolled hypertension, defined as systolic BP > 180 mmHg or diastolic BP > 110 mmHg on two consecutive readings at least 5 minutes apart, despite initial ED management.
- •Hemodynamic instability, including persistent hypotension (SBP < 90 mmHg) or tachyarrhythmias requiring urgent treatment.
- •Significant chronic lung disease, including:
- •COPD with frequent exacerbations or baseline FEV₁ < 50% predicted
- •Interstitial lung disease (ILD)
- •Clinically significant bronchiectasis with baseline productive cough or infection
- •Pregnancy or currently breastfeeding.
- •Home BiPAP use or requirement for non-invasive ventilation (e.g., BiPAP/CPAP) during the ED visit (Note: isolated home CPAP for sleep apnea without daytime symptoms is acceptable).
- •Current intubation or imminent need for mechanical ventilation based on clinical judgment.
- •Severe cardiac disease, including decompensated heart failure, recent myocardial infarction (<6 weeks), or known severe valvular disease.
- •Any other medical, surgical, or psychiatric condition that in the opinion of the investigator would place the patient at undue risk from study participation or interfere with the interpretation of study results.
研究组 & 干预措施
Nebulized ketamine (0.5 mg/kg) + standard care for moderate to severe asthma exacerbation
Participants in the intervention arm will receive a single dose of nebulized ketamine at 0.5 mg/kg, diluted in normal saline to a total volume of 5ml, administered via a standard jet nebulizer. This will be given after standard asthma care, which includes salbutamol, ipratropium bromide, systemic corticosteroids (e.g., oral prednisolone or IV hydrocortisone), and supplemental oxygen as needed. The goal is to assess whether adding nebulized ketamine improves respiratory function, measured by peak expiratory flow rate (PEFR), compared to standard care alone. Participants will be monitored for 60 minutes after treatment for changes in PEFR, symptom relief, and any adverse effects. The intervention is non-invasive and administered in the emergency department for adult patients with moderate to severe asthma exacerbations.
干预措施: Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare (Drug)
Placebo nebulization (normal saline) + standard care for moderate to severe asthma exacerbation
Participants in the control arm will receive a placebo nebulization consisting of 5 mL of normal saline, administered via a standard jet nebulizer. This will be given in addition to standard asthma care, which includes salbutamol, ipratropium bromide, systemic corticosteroids (e.g., oral prednisolone or IV hydrocortisone), and supplemental oxygen as needed. The placebo is indistinguishable in appearance and administration method from the active treatment to maintain blinding. This arm is designed to evaluate the effects of standard care alone on peak expiratory flow rate (PEFR), symptom relief, and adverse events, and will be compared to the intervention group receiving nebulized ketamine. All participants will be monitored for 60 minutes following treatment in the emergency department setting.
干预措施: Placebo nebulization (5 mL normal saline) plus standard asthma care (Drug)
结局指标
主要结局
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 60 minutes post-intervention
时间窗: Baseline (0 minutes) and 60 minutes post-intervention
PEFR will be measured using a peak flow meter at baseline (0 minutes) and at 60 minutes after administration of the intervention. The change in PEFR will be calculated to assess the intervention effect.
次要结局
- • Incidence of adverse effects(60 minutes)
- Change in PEFR at 30 minutes(30 minutes)
- Incidence of intravenous magnesium sulfate administration(60 minutes)
- Incidence of ICU admission(60 minutes)
- Incidence of endotracheal intubation(60 minutes)
- Incidence of non-invasive ventilation (BiPAP) initiation(60 minutes)
- Disposition plan (discharged, admitted, or transferred)(60 minutes)
- Length of stay (if admitted)(60 minutes)
- Type of admission bed (e.g., ward vs. ICU)(60 minutes)
- Change in dyspnea severity as measured by the Visual Analogue Scale (VAS)(60 minutes)
研究者
Al Mahanad Al Julandani
Emergency Medicine Resident Doctor
Oman Medical Speciality Board