Acute Respiratory Failure (ARF)NCT07182695
Cervical Erector Spinae Plane Block for Dyspnea in Acute Respiratory Failure: A Prospective Cohort
An observational study of Acute Respiratory Failure (ARF) and Dyspnea, run by Hacettepe University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Failure (ARF), Dyspnea
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients in the mixed medical-surgical ICU of a tertiary university hospital (Hacettepe University Hospital, Ankara, Türkiye). The ICU manages acute respiratory failure due to pneumonia, COPD/asthma, pulmonary edema, and post-operative causes. Patients who receive a cervical ESP block for dyspnea as are observed for changes over 24 hours.
Who may be able to join
- ICU admission with acute respiratory failure.
- Patient or legally authorized representative provides consent.
- Cervical ESP block performed for dyspnea treatment
Who cannot join
- Infection at block site.
- Known diaphragm paralysis.
- Known allergy to local anesthetics.
- Refusal of consent (patient or representative).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Bilateral Cervical Erector Spinae Plane Block on Dyspnea in Patients With Acute Respiratory Failure: A Prospective Single-Cohort Study
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.
Read the 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).
- Conditions
- Acute Respiratory Failure (ARF), Dyspnea
- Keywords
- Cervical ESP block, Diaphragm ultrasound, Intensive care, Ultrasound-guided regional anesthesia
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cervical ESP cohort | adults with acute respiratory failure receiving bilateral cervical ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dyspnea by Visual Analog Scale (D-VAS)
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.
Measured: Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.
Secondary outcomes (9)
Respiratory Distress Observation Scale (RDOS) Score
Observer-rated RDOS (higher scores indicate more severe respiratory distress); standard scoring per instrument.
Measured: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.
Intensive Care Respiratory Distress Observation Scale (IC-RDOS) Score
Observer-rated IC-RDOS (higher scores worse); standard scoring per instrument.
Measured: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.
Diaphragm Excursion Amplitude on Ultrasound
Peak-to-peak diaphragm excursion amplitude measured bilaterally with bedside ultrasound/M-mode.
Measured: Baseline (pre-block), 30 minutes
Arterial Blood Gas Parameters: pH, PaO₂, PaCO₂ , SaO₂, HCO₃-
Abstracted from ABGs
Measured: Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.
Adverse Events Related to ESP Block
Number of participants with any block-related AE within 24 hours, per chart review/clinical documentation.
Measured: From block through 24 hours.
Respiratory Rate (Breaths/minute)
Respiratory Rate recorded per routine monitoring.
Measured: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.
Heart Rate (Beats/minute)
Heart rate recorded per routine monitoring.
Measured: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.
SpO₂ (%)
SpO₂ recorded per routine monitoring.
Measured: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.
Blood Pressure (mm-Hg)
Blood Pressure recorded per routine monitoring.
Measured: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure (ARF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağrı Arslan, Hacettepe University
- Investigators
- Seda Banu AKINCI, Professor, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182695
- Sponsor's protocol ID
- KA-25017
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided