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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Cervical Erector Spinae Plane Block on Dyspnea in Patients With Acute Respiratory Failure: A Prospective Single-Cohort Study
- ClinicalTrials.gov ID
- NCT07182695
- Acronym / sponsor ID
- KA-25017
- Conditions
- Acute Respiratory Failure (ARF), Dyspnea
- Keywords
- Cervical ESP block, Diaphragm ultrasound, Intensive care, Ultrasound-guided regional anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical ESP cohort | – | –adults with acute respiratory failure receiving bilateral cervical ESP block |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- ICU admission with acute respiratory failure.
- Patient or legally authorized representative provides consent.
- Cervical ESP block performed for dyspnea treatment
Key exclusion criteria (4 listed)
- Infection at block site.
- Known diaphragm paralysis.
- Known allergy to local anesthetics.
- Refusal of consent (patient or representative).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seda Banu AKINCI, Professor principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure (ARF) and Dyspnea, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Çağrı Arslan, Resident (+90 551 722 26 60, cagriarslan96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.