Sequential Strategy of Palpation Plus Ultrasound vs Palpation vs Routine Ultrasound , in Adults for Detection of Cricothyroid Membrane: Protocol of an Adaptive Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Proportion of adequate cricothyroid membrane identification by group
研究概览
简要总结
EcoID is a study designed as an adaptive controlled clinical trial with a first phase of superiority and a second phase of non-inferiority with change of control, of parallel groups, random assignment and blinding of investigators measuring outcome.
详细描述
Methodology: Methods, techniques and tools provided. Describe the design, study population, materials, procedures and analysis plan:
EcoID is a study designed as an adaptive controlled clinical trial with a first phase of superiority and a second phase of non-inferiority with change of control, of parallel groups, random assignment and blinding of investigators measuring outcome.
A Bayesian statistical approach will be used for the analysis and inferences of the information obtained from the clinical trial. The use of an adaptive study is justified given that there is uncertainty if the sequential strategy is superior to palpation, so performing the sequential experiment optimizes sample collection. In case the intervention does not pass phase 1, it is not necessary to expose more patients to compare the intervention by the second control.
By using a Bayesian statistical approach, it is possible to use the phase 1 sample as a prior probability distribution.
Therefore, the adaptive sample of phase 2 is optimized, achieving the best statistical performance with the least amount of time and resources, benefits found in this type of design The study population will be adult patients of the IPS Universitaria, who accept participation in the study and sign the informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Older than 18 years-old.
- •Acceptance of participation in the clinical study
- •Informed consent signature
- •Hopitalizated
排除标准
- •Patients with tracheostomy or other ventilation devices in the cervical region
研究组 & 干预措施
Palpation with " laryngeal handshake" technique "
With the non-dominant hand, the larynx is stabilized, the hyoid bone is identified with the thumb and index finger by palpation of the greater horns with a horizontal movement from side to side, move thumb and fingers inferiorly to locate thyroid cartilage,Once identified, its location is maintained with the middle finger and thumb, and the index finger travels towards the midline.
The index finger, already in the midline, makes a longitudinal movement downwards to determine the small depression between the cricoid and thyroid cartilage that corresponds to the cricothyroid membrane.
干预措施: Palpation with " laryngeal handshake" technique (Diagnostic Test)
Palpation strategy plus sequential ultrasound
Palpation is performed with the previously described laryngeal handshake technique If the participant is unable to identify the location of the cricothyroid membrane with certainty, the mixed ultrasound protocol is continued. as decribed in Identification of the cricothyroid membrane with ultrasound
干预措施: Palpation strategy plus sequential ultrasound (Diagnostic Test)
Identification of the cricothyroid membrane with routine ultrasound
With the patient on a supine stretcher position, neck extended, with a linear transducer and ultrasound gel, a cross-sectional evaluation of the airway is performed, identifying the cartilaginous referents of the airway. In this case, the midline referent will be the union of the laminae of the thyroid cartilage. The midpoint of the hyperechoic image is located between both referents (MCT).
Next, tracheal rings are identified, the transducer is moved laterally and a 90° turn is performed for axial evaluation of the MCT. The aim is to preserve the same anatomical landmarks already identified in the transverse plane, the cephalocaudal distance between the thyroid cartilage and the cricoid is evaluated, locating the midpoint with the help of the acoustic shadow generated by a yelco without a needle. Based on these 2 measurements, the topographical location of the MCT will be marked with a visible ink marker under UV light, which will serve as a benchmark for comparison.
干预措施: Identification of the cricothyroid membrane with routine ultrasound (Diagnostic Test)
结局指标
主要结局
Proportion of adequate cricothyroid membrane identification by group
时间窗: through study completion, an average of 30 minutes
Adequate Identification of the cricothyroid membrane For the present study, it is defined as the concordance between the marking performed by any of the interventions and the marking performed by an expert. This must have a distance of less than 5 mm both in the axial and longitudinal planes. An expert in the field is defined as a professional who works using advanced airway management strategies, and has published on airway ultrasonography and/or performs a CUSUM curve for MCT identification \>90%.
次要结局
- Perception of adherence to the technique(through study completion, an average of 10 minutes)
- Longitudinal deviation(through study completion, an average of 10 minutes)
- Lateral deviation in mm(through study completion, an average of 10 minutes)
- Participant satisfaction(through study completion, an average of 10 minutes)
- Satisfaction of the administrators of the intervention(through study completion, an average of 10 minutes)
- Degree of difficulty(30 minutes)
- Time to detection(through study completion, an average of 10 minutes)