Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 12:55 PM
Study NCT ID:
NCT07182695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Erector Spinae Plane Block for Dyspnea in Acute Respiratory Failure: A Prospective Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Dyspnea by Visual Analog Scale (D-VAS)', 'timeFrame': 'Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Respiratory Distress Observation Scale (RDOS) Score', 'timeFrame': 'Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.', 'description': 'Observer-rated RDOS (higher scores indicate more severe respiratory distress); standard scoring per instrument.'}, {'measure': 'Intensive Care Respiratory Distress Observation Scale (IC-RDOS) Score', 'timeFrame': 'Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.', 'description': 'Observer-rated IC-RDOS (higher scores worse); standard scoring per instrument.'}, {'measure': 'Diaphragm Excursion Amplitude on Ultrasound', 'timeFrame': 'Baseline (pre-block), 30 minutes', 'description': 'Peak-to-peak diaphragm excursion amplitude measured bilaterally with bedside ultrasound/M-mode.'}, {'measure': 'Arterial Blood Gas Parameters: pH, PaO₂, PaCO₂ , SaO₂, HCO₃-', 'timeFrame': 'Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.', 'description': 'Abstracted from ABGs'}, {'measure': 'Adverse Events Related to ESP Block', 'timeFrame': 'From block through 24 hours.', 'description': 'Number of participants with any block-related AE within 24 hours, per chart review/clinical documentation.'}, {'measure': 'Respiratory Rate (Breaths/minute)', 'timeFrame': 'Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.', 'description': 'Respiratory Rate recorded per routine monitoring.'}, {'measure': 'Heart Rate (Beats/minute)', 'timeFrame': 'Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.', 'description': 'Heart rate recorded per routine monitoring.'}, {'measure': 'SpO₂ (%)', 'timeFrame': 'Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.', 'description': 'SpO₂ recorded per routine monitoring.'}, {'measure': 'Blood Pressure (mm-Hg)', 'timeFrame': 'Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.', 'description': 'Blood Pressure recorded per routine monitoring.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical ESP block', 'Diaphragm ultrasound', 'Intensive care', 'Ultrasound-guided regional anesthesia'], 'conditions': ['Acute Respiratory Failure (ARF)', 'Dyspnea']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU admission with acute respiratory failure.\n* Patient or legally authorized representative provides consent.\n* Cervical ESP block performed for dyspnea treatment\n\nExclusion Criteria:\n\n* Infection at block site.\n* Known diaphragm paralysis.\n* Known allergy to local anesthetics.\n* Refusal of consent (patient or representative).'}, 'identificationModule': {'nctId': 'NCT07182695', 'briefTitle': 'Cervical Erector Spinae Plane Block for Dyspnea in Acute Respiratory Failure: A Prospective Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Effect of Bilateral Cervical Erector Spinae Plane Block on Dyspnea in Patients With Acute Respiratory Failure: A Prospective Single-Cohort Study', 'orgStudyIdInfo': {'id': 'KA-25017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cervical ESP cohort', 'description': 'adults with acute respiratory failure receiving bilateral cervical ESP block'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Çağrı Arslan, Resident', 'role': 'CONTACT', 'email': 'cagriarslan96@gmail.com', 'phone': '+90 551 722 26 60'}], 'overallOfficials': [{'name': 'Seda Banu AKINCI, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Çağrı Arslan', 'investigatorAffiliation': 'Hacettepe University'}}}}