A Randomised Control Trial to Determine Whether Intervention Based on a Microstream Capnography-based Ventilation Monitoring System Will Decrease Hypoxaemaia During Intravenous Sedation With Midazolam.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Arterial oxygen desaturation (SpO2 < 95%)
研究概览
简要总结
Dentists use sedation to help patients accept difficult procedures and to relieve anxiety. During sedation, the well-being of the patient is monitored by the dental team. When carried out according to recognised guidelines,intravenous dental sedation is considered to be very safe. For some patients, dental sedation is a useful alternative to general anaesthetic. It is cheaper and has the potential to be more accessible. Oximetry(measurement of oxygen status) is the current gold standard in dental sedation. The main risk to the patient during sedation is a slowing of breathing due to the effects of the sedative drug. Studies from other settings where sedation is practiced suggest that an additional monitor with capnography facilitates early detection of depressed breathing. However, the results of studies from other medical settings cannot be generalised to dental sedation, because of different techniques used and the types of patients. The depth of sedation may also be vary. For dental sedation, patients remain responsive at all times and breathe for themselves. Capnography gives breath by breath information using a simple device placed close to the nose and mouth. It has been recommended by several governing medical bodies that each area of medicine, should develop its own guidelines for sedation. Therefore, there is a need to research the application of capnography for dental sedation. The proposed study will take place at a university hospital site. Patients will be randomly divided into two groups. Both groups will receive sedation in the normal way. The study group will have capnography monitoring added. The study will look for differences in breathing between the two groups. Additional information regarding other aspects of monitoring will also be obtained. The results from the proposed study may help to improve patient safety and change current practice during sedation for dentistry.
详细描述
Background Intravenous sedation allows procedures to be performed in dentistry, and other areas of medicine beyond the operating room. Its application in each area is tailored to the requirements of the relevant procedure, the setting and the levels of operator training and expertise. The Academy of Medical Royal Colleges emphasises that each speciality must produce its own form of guidance in the use of sedative techniques. The following definition for conscious sedation in dentistry is accepted by the General Dental Council and the Dental Sedation Teachers Group: "A technique in which the use of a drug or drugs produces a state of depression of the central nervous system enabling treatment to be carried out, but during which verbal contact with the patient is maintained throughout the period of sedation. The drugs and techniques used to provide conscious sedation for dental treatment should carry a margin of safety wide enough to render loss of consciousness unlikely". The Standing Dental Advisory Committee Guidance 2003, which remains the standard of guidance in the UK, further states: "Any technique resulting in the loss of consciousness is defined as general anaesthesia and in the UKm 'deep sedation' is considered within this category". To summarise; dental sedation lies within the range of minimal to moderate sedation on the sedation continuum i.e. conscious sedation. Deep sedation is to be avoided in this setting.
Dentists who have completed a recognised postgraduate course can practice conscious sedation independently. For intravenous sedation, dentists use a "standard" conscious sedation technique, defined as "intravenous sedation", using midazolam alone. The drug is titrated to an end-point; it is rapid in onset and possesses a short duration of action, which means that midazolam is very useful in the field of dental sedation.
The current standard of monitoring for patients is clinical monitoring, which must be supplemented by pulse oximetry and blood pressure readings. The most important side effect of midazolam is respiratory depression.
Although it is generally considered a safe practice, conscious sedation is not entirely risk-free.Ventilation (breathing) and oxygenation are related but seperate physiological processes. During the process of sedation, clinicians rely on pulse oximetry as a surrogate measure of ventilation. Capnography, a staple gold standard in general anaesthesia, is becoming an increasingly important area of interest for procedural sedation, with studies from other settings suggesting, capnography to be an effective ventilatory monitor for sedated patients.
One significant limitation of pulse oximetry is the lag time; this means that the partial pressure of oxygen may decrease significantly before the pulse oximeter signals the fall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anaesthesiologists (ASA) class 1 & 2 only
- •Age 14years to 65 years
- •Ability to give written informed consent
排除标准
- •Inability to give informed consent
- •Body Mass Index > 35 Kg/M2
- •Procedure in the upper anterior region of the mouth which prevents placement of the oral - nasal sampling device
结局指标
主要结局
Arterial oxygen desaturation (SpO2 < 95%)
时间窗: "participants will be followed for the duration of their sedation appointment, an expected average of one hour"
This primary outcome measure was chosen in part because it represents a threshold point for sedation staff to stimulate patients to breathe via tactile or verbal actions.
次要结局
- Degree of hypoxemia("participants will be followed for the duration of their sedation appointment, an expected average of one hour)
研究者
Dr Paul Brady
Clinical Fellow
University College Cork
