Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations

Официальное название

Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations: A Randomized Clinical Trial (KET-AIR Trial)

Обзор

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

Вмешательства

• Препарат Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare
  \*\*Intervention Description:\*\* Nebulized ketamine is administered as a single dose of 0.5 mg/kg of ketamine hydrochloride diluted in 0.9% normal saline to a total volume of 5ml. The solution is delivered via a standard jet nebulizer over approximately 15-20minutes. This intervention is given once at the time of enrollment in the emergency department, in addition to standard asthma care. The ketamine used is in injectable solution form (typically 50 mg/mL concentration), drawn and diluted imme
• Препарат Placebo nebulization (5 mL normal saline) plus standard asthma care
  \*\*Intervention Description (Control Group):\*\* Participants in the control group will receive a single nebulized dose of 5 mL of 0.9% normal saline, delivered using a standard jet nebulizer over approximately 10-15 minutes. This placebo intervention is administered once at the time of enrollment in the emergency department, after standard asthma care. Standard care includes repeated doses of nebulized salbutamol and ipratropium, systemic corticosteroids (oral or intravenous), and supplemental

Первичные конечные точки

• Change in Peak Expiratory Flow Rate (PEFR) from baseline to 60 minutes post-intervention [Срок оценки: Baseline (0 minutes) and 60 minutes post-intervention]

Вторичные конечные точки (10)

• Change in PEFR at 30 minutes [Срок оценки: 30 minutes]
• • Incidence of adverse effects [Срок оценки: 60 minutes]
• Incidence of intravenous magnesium sulfate administration [Срок оценки: 60 minutes]
• Incidence of ICU admission [Срок оценки: 60 minutes]
• Incidence of endotracheal intubation [Срок оценки: 60 minutes]
• Incidence of non-invasive ventilation (BiPAP) initiation [Срок оценки: 60 minutes]
• Disposition plan (discharged, admitted, or transferred) [Срок оценки: 60 minutes]
• Length of stay (if admitted) [Срок оценки: 60 minutes]
• Type of admission bed (e.g., ward vs. ICU) [Срок оценки: 60 minutes]
• Change in dyspnea severity as measured by the Visual Analogue Scale (VAS) [Срок оценки: 60 minutes]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07112456 · OMSB24030

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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