Cervical Erector Spinae Plane Block for Dyspnea in Acute Respiratory Failure: A Prospective Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Failure (ARF), Dyspnea. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Bilateral Cervical Erector Spinae Plane Block on Dyspnea in Patients With Acute Respiratory Failure: A Prospective Single-Cohort Study
Overview
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.
Detailed description
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).
Primary outcome measures
- Change in Dyspnea by Visual Analog Scale (D-VAS) [Time frame: Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.]
Secondary outcome measures (9)
- Respiratory Distress Observation Scale (RDOS) Score [Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.]
- Intensive Care Respiratory Distress Observation Scale (IC-RDOS) Score [Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.]
- Diaphragm Excursion Amplitude on Ultrasound [Time frame: Baseline (pre-block), 30 minutes]
- Arterial Blood Gas Parameters: pH, PaO₂, PaCO₂ , SaO₂, HCO₃- [Time frame: Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.]
- Adverse Events Related to ESP Block [Time frame: From block through 24 hours.]
- Respiratory Rate (Breaths/minute) [Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.]
- Heart Rate (Beats/minute) [Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.]
- SpO₂ (%) [Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.]
- Blood Pressure (mm-Hg) [Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.]
Eligibility criteria
Inclusion criteria
- ICU admission with acute respiratory failure.
- Patient or legally authorized representative provides consent.
- Cervical ESP block performed for dyspnea treatment
Exclusion criteria
- Infection at block site.
- Known diaphragm paralysis.
- Known allergy to local anesthetics.
- Refusal of consent (patient or representative).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07182695 · KA-25017