Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-31 @ 12:18 PM
Study NCT ID:
NCT05190458
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2021-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}], 'ancestors': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-10-17', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluation of HVNI in correction of Hypoxemia.', 'timeFrame': 'Baseline', 'description': 'Evaluation of the effectiveness of HVNI in correction of Hypoxemia through measurement of O2 saturation by percentage % via pulse oximeter.'}], 'primaryOutcomes': [{'measure': 'Evaluation of HVNI in correction of Acidosis .', 'timeFrame': 'Baseline', 'description': 'Evaluation of the effectiveness of HVNI in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).'}, {'measure': 'Evaluation of HVNI in correction of Hypercapnia.', 'timeFrame': 'Baseline', 'description': 'Evaluation of the effectiveness of HVNI in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of HVNI in management of respiratory failure.', 'timeFrame': 'Baseline', 'description': 'Evaluation of the effectiveness of HVNI in management of respiratory failure through measurement of PO2 via arterial blood gases test (ABG)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overlap Syndrome', 'Obesity Hypoventilation Syndrome']}, 'referencesModule': {'references': [{'pmid': '32273085', 'type': 'BACKGROUND', 'citation': 'Doshi PB, Whittle JS, Dungan G 2nd, Volakis LI, Bublewicz M, Kearney J, Miller TL, Dodge D, Harsch MR, DeBellis R, Chambers KA. The ventilatory effect of high velocity nasal insufflation compared to non-invasive positive-pressure ventilation in the treatment of hypercapneic respiratory failure: A subgroup analysis. Heart Lung. 2020 Sep-Oct;49(5):610-615. doi: 10.1016/j.hrtlng.2020.03.008. Epub 2020 Apr 6.'}, {'pmid': '29310868', 'type': 'BACKGROUND', 'citation': 'Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.'}, {'pmid': '28282995', 'type': 'BACKGROUND', 'citation': 'Poh TY, Mac Aogain M, Chan AK, Yii AC, Yong VF, Tiew PY, Koh MS, Chotirmall SH. Understanding COPD-overlap syndromes. Expert Rev Respir Med. 2017 Apr;11(4):285-298. doi: 10.1080/17476348.2017.1305895. Epub 2017 Mar 24.'}, {'pmid': '32061194', 'type': 'BACKGROUND', 'citation': 'Orr JE, Schmickl CN, Edwards BA, DeYoung PN, Brena R, Sun XS, Jain S, Malhotra A, Owens RL. Pathogenesis of obstructive sleep apnea in individuals with the COPD + OSA Overlap syndrome versus OSA alone. Physiol Rep. 2020 Feb;8(3):e14371. doi: 10.14814/phy2.14371.'}, {'pmid': '30872398', 'type': 'BACKGROUND', 'citation': 'Masa JF, Pepin JL, Borel JC, Mokhlesi B, Murphy PB, Sanchez-Quiroga MA. Obesity hypoventilation syndrome. Eur Respir Rev. 2019 Mar 14;28(151):180097. doi: 10.1183/16000617.0097-2018. Print 2019 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with overlap syndrome.\n\nThis study aims to evaluate the effectiveness of HVNI compared to NIMV in management of respiratory failure in patients with obesity hypoventilation syndrome and overlap syndrome.', 'detailedDescription': 'Overlap syndrome (OVS) is the concurrence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), and is associated with poor outcomes.\n\nCOPD and obstructive sleep apnoea (OSA) are highly prevalent and different clinical COPD phenotypes that influence the likelihood of comorbid OSA.\n\nThe increased lung volumes and low body mass index (BMI) associated with the predominant emphysema phenotype protects against OSA whereas the peripheral oedema and higher BMI often associated with the predominant chronic bronchitis phenotype promote OSA.\n\nThe diagnosis of OSA in COPD patients requires clinical awareness and screening questionnaires which may help identify patients for overnight study.\n\nManagement of OSA-COPD overlap patients differs from COPD alone and the survival of overlap patients treated with nocturnal positive airway pressure is superior to those untreated.\n\nhigh flow nasal cannula (HFNC), which delivers heated, humidified oxygen via a nasal cannula at high flow rates of up to 60 L/min, delivering a maximum of 100% oxygen, has been shown to be effective in the treatment of respiratory failure.\n\nHigh velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with obesity hypoventilation syndrome and overlap syndrome.\n\nThis study aims to evaluate the effectiveness of HVNI compared to NIMV in management of respiratory failure in patients with overlap syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with respiratory failure in obesity hypoventilation syndrome and overlap syndrome, requiring ICU admission and fulfill criteria of NIMV supplementation (GOLD criteria 2021)\n* patients with obesity hypoventilation syndrome and overlap syndrome diagnosed by polysomnogram or through STOP BANG Questionnaire or EPWORTH Sleepness Scale.\n\nExclusion Criteria:\n\n* Patients less than 18 years old\n* Patients with hemodynamic instability\n* Patients with central causes of hypercapnic respiratory failure\n* Patients with disturbed conscious level\n* Patients who refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT05190458', 'acronym': 'HVNI', 'briefTitle': 'Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome.', 'orgStudyIdInfo': {'id': 'HVNI in Overlap syndrome'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Non-invasive mechanical ventilation (group A)', 'description': 'Patients will be Randomized into 2 subgroups by (1:1) crossover:- Group A will be put on NIMV Group B will be put on HVNI', 'interventionNames': ['Other: Non-invasive mechanical ventilation']}, {'type': 'OTHER', 'label': 'High Velocity Nasal Insufflation (group B)', 'description': 'Patients will be Randomized into 2 subgroups by (1:1) crossover:- Group A will be put on NIMV Group B will be put on HVNI', 'interventionNames': ['Other: High Velocity Nasal Insufflation']}], 'interventions': [{'name': 'High Velocity Nasal Insufflation', 'type': 'OTHER', 'description': 'High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with overlap syndrome.', 'armGroupLabels': ['High Velocity Nasal Insufflation (group B)']}, {'name': 'Non-invasive mechanical ventilation', 'type': 'OTHER', 'description': 'Noninvasive ventilation (NIV) refers to the administration of ventilatory support without using an invasive artificial airway (endotracheal tube or tracheostomy tube).', 'armGroupLabels': ['Non-invasive mechanical ventilation (group A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Abanoub H Sadek Farag, Resident', 'role': 'CONTACT', 'email': 'Abanoubabanoubhanysadek@outlook.com', 'phone': '+201279269591'}], 'facility': 'Respiratory ICU in Assiut University Hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Abanoub H Sadek Farag, Resident', 'role': 'CONTACT', 'email': 'Abanoubabanoubhanysadek@outlook.com', 'phone': '+201279269591'}], 'overallOfficials': [{'name': 'Ashraf Z El-Abdeen Mohammed, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chest Diseases and Tuberculosis Department-Assiut University Hospitals'}, {'name': 'Lamiaa H Shaaban, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Chest Diseases and Tuberculosis Department-Assiut University Hospitals'}, {'name': 'Waleed G Elddin Khaleel, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Chest Diseases and Tuberculosis Department-Assiut University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor at chest department-Assiut University Hospitals', 'investigatorFullName': 'Abanoub Hany Sadek Farag', 'investigatorAffiliation': 'Assiut University'}}}}