NCT07182695

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 4, 2025

Last Update Submit

September 12, 2025

Conditions

Keywords

Cervical ESP blockDiaphragm ultrasoundIntensive careUltrasound-guided regional anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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.

  • +4 more secondary outcomes

Study Arms (1)

Cervical ESP cohort

adults with acute respiratory failure receiving bilateral cervical ESP block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • ICU admission with acute respiratory failure.
  • Patient or legally authorized representative provides consent.
  • Cervical ESP block performed for dyspnea treatment

You may not qualify if:

  • Infection at block site.
  • Known diaphragm paralysis.
  • Known allergy to local anesthetics.
  • Refusal of consent (patient or representative).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seda Banu AKINCI, Professor

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Çağrı Arslan, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 19, 2025

Study Start

September 15, 2025

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09