Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT04109560
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HFNC and Acute Hypercapnic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for non-invasive ventilation', 'timeFrame': 'From inclussion study date until the first day of noninvasive ventilation use documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.', 'description': 'The need and causes for non-invasive ventilation will be recorded in the all study period.'}, {'measure': 'Need for endotracheal intubation', 'timeFrame': 'From inclussion study date until the first day of endotracheal intubation documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.', 'description': 'The need and causes for endotracheal intubation will be recorded in the all study period.'}], 'secondaryOutcomes': [{'measure': 'Gas Exchange', 'timeFrame': 'Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment', 'description': 'pH will be recorded'}, {'measure': 'Gas Exchange', 'timeFrame': 'Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment', 'description': 'PaCO2 in milimeters of mercury (mmHg) will be recorded'}, {'measure': 'Gas Exchange', 'timeFrame': 'Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment', 'description': 'PaO2 in milimeters of mercury (mmHg) will be recorded'}, {'measure': 'Respiratory variables', 'timeFrame': 'Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment', 'description': 'Respiratory rate in numbers of breaths per minute (bpm) will be recorded'}, {'measure': 'Respiratory variables', 'timeFrame': 'Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment', 'description': 'Accessory muscular use (intercostal or supraclavicular) by "YES or NO" will be recorded'}, {'measure': 'Respiratory variables', 'timeFrame': 'Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment', 'description': 'Thoraco-abdominal asynchrony by "YES or NO" will be recorded'}, {'measure': "Patient's discomfort", 'timeFrame': "Patient's discomfort will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment", 'description': 'Discomfort related to the high flow oxygen therapy and related to the degree of humidification will be assessed by using a numerical rating scale from 1 (no discomfort) to 5 (maximum imaginable discomfort). Patients will be asked to rate their discomfort with the used device and discomfort symptoms will be determined for the dryness of the delivered oxygen (dryness of the mouth, throat, nose, difficulty to swallow and throat pain).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Flow Oxygen Therapy', 'Acute Hypercapnic Respiratory Failure', 'COPD Exacerbation']}, 'descriptionModule': {'briefSummary': 'High-flow nasal cannula (HFNC) enables delivering humidified gas at high-flow rates controlling the oxygen inspired fraction (FiO2). Its efficacy has been demonstrated in hypoxemic acute respiratory failure. However, little is known about its use in hypercapnic acute respiratory failure (ARF). Therefore, we aimed to evaluate the effect of using HFNC through "Precision Flow" equipment as first line of ventilatory support for COPD patients with hypercapnic acute respiratory failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Moderate to very severe COPD patients (GOLD 2 to 4) admitted to the ICU with acute hypercapnic respiratory failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to very severe COPD patients (GOLD 2 to 4) over 18 years old admitted to the ICU with hypercapnic ARF (PaCO2\\> 45 mmHg and respiratory acidosis \\[pH ≥7.30\\], with or without hypoxemia + one of the following: Respiratory Rate ≥25 cycles per minute, intercostal and / or supraclavicular recruitment, or thoraco-abdominal synchrony, no prior use of NIV)\n\nExclusion Criteria:\n\n* Patients less than 18 years old\n* Mild COPD patients\n* Absence of hypercapnia\n* Kelly M Score \\> 3\n* Haemodynamic instability (despite fluid resuscitation)\n* NIV or Invasive Mechanical Ventilation (IMV) (Need to use previously to HFNC)\n* Contraindications to implement high-flow oxygen therapy.'}, 'identificationModule': {'nctId': 'NCT04109560', 'briefTitle': 'HFNC and Acute Hypercapnic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Argentinian Intensive Care Society'}, 'officialTitle': 'High Flow Nasal Oxygen Therapy in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure (AHRF)', 'orgStudyIdInfo': {'id': 'Hi-VNI in AHRF'}}, 'contactsLocationsModule': {'locations': [{'zip': '1425', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Sanatorio Anchorena'}], 'overallOfficials': [{'name': 'Gustavo A Plotnikow', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanatorio Anchorena Recoleta'}, {'name': 'Mariano Setten', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)'}, {'name': 'Norberto Tiribelli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complejo Médico Policial Churruca-Visca'}, {'name': 'Sebastian Fredes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanatorio de la Trinidad Mitre'}, {'name': 'Matias Accoce', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanatorio Anchorena San Martín'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Argentinian Intensive Care Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapist', 'investigatorFullName': 'Gustavo Plotnikow', 'investigatorAffiliation': 'Argentinian Intensive Care Society'}}}}