Effect of Bilateral Cervical Erector Spinae Plane Block on Dyspnea in Patients With Acute Respiratory Failure: A Prospective Single-Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in Dyspnea by Visual Analog Scale (D-VAS)
研究概览
简要总结
Dyspnea is common and distressing in patients with acute respiratory failure. In our intensive care unit, some patients receive a cervical erector spinae plane (ESP) block to help relieve dyspnea. This study will observe patients who receive bilateral cervical ESP blocks and measure changes in dyspnea using validated scales at predefined time points over 24 hours. We will also track vital signs, arterial blood gas values, and diaphragm movement on ultrasound.
详细描述
Prospective, single-cohort observational study in an adult ICU. Consecutive eligible patients with acute respiratory failure who receive bilateral cervical ESP block will be enrolled. Dyspnea severity will be measured using a 100-mm Dyspnea Visual Analog Scale (D-VAS), the Respiratory Distress Observation Scale (RDOS), and the Intensive Care RDOS (IC-RDOS) before the block (baseline) and at 30 minutes, 8 hours, 16 hours, and 24 hours after the block. Vital signs (respiratory rate, heart rate, peripheral oxygen saturation, blood pressure) will be recorded at the same time points. From arterial blood gases, pH, PaO₂, PaCO₂, SaO₂, and HCO₃- will be abstracted. Bilateral diaphragm excursion amplitude will be measured with bedside ultrasound. Statistical plan includes normality checks; repeated-measures ANOVA for parametric data or Friedman test for nonparametric data; paired t-test or Wilcoxon as needed; chi-square or Fisher's exact for categorical variables. Planned sample size: 30 (power analysis for repeated measures with effect size 0.25, α=0.05, power=0.90).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU admission with acute respiratory failure.
- •Patient or legally authorized representative provides consent.
- •Cervical ESP block performed for dyspnea treatment
排除标准
- •Infection at block site.
- •Known diaphragm paralysis.
- •Known allergy to local anesthetics.
- •Refusal of consent (patient or representative).
结局指标
主要结局
Change in Dyspnea by Visual Analog Scale (D-VAS)
时间窗: Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.
Patient-reported dyspnea on a 100-mm line (0=no dyspnea, 100=worst imaginable); measured in mm from 0 anchor to the patient's mark.
次要结局
- Respiratory Rate (Breaths/minute)(Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.)
- Heart Rate (Beats/minute)(Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.)
- Respiratory Distress Observation Scale (RDOS) Score(Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.)
- Intensive Care Respiratory Distress Observation Scale (IC-RDOS) Score(Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.)
- Diaphragm Excursion Amplitude on Ultrasound(Baseline (pre-block), 30 minutes)
- Arterial Blood Gas Parameters: pH, PaO₂, PaCO₂ , SaO₂, HCO₃-(Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.)
- Adverse Events Related to ESP Block(From block through 24 hours.)
- SpO₂ (%)(Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.)
- Blood Pressure (mm-Hg)(Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.)
研究者
Çağrı Arslan
Principal Investigator
Hacettepe University