Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-17 @ 10:12 AM
Study NCT ID:
NCT02363920
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2015-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Term Physiological Effects of Nasal High Flow Oxygen on Respiratory Mechanics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-08', 'studyFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2015-02-13', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recording of respiratory mechanics', 'timeFrame': '30 minutes per arm', 'description': "Respiratory mechanics will be assessed using Mead and Wittenberger's technique."}], 'secondaryOutcomes': [{'measure': 'dyspnea score', 'timeFrame': '30 minutes per arm', 'description': 'dyspnea will be recorded using the Borg scale that is a numeric scale where 0 is no dyspnea and 10 the maximal dyspnea that a patient can imagine'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD patients'], 'conditions': ['COPD', 'Chronic Hypercapnic Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '28104830', 'type': 'DERIVED', 'citation': 'Pisani L, Fasano L, Corcione N, Comellini V, Musti MA, Brandao M, Bottone D, Calderini E, Navalesi P, Nava S. Change in pulmonary mechanics and the effect on breathing pattern of high flow oxygen therapy in stable hypercapnic COPD. Thorax. 2017 Apr;72(4):373-375. doi: 10.1136/thoraxjnl-2016-209673. Epub 2017 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'Nasal High Oxygen Flow (HOF) has been demonstrated to reduce the re-intubation rate in hypoxic patients and ameliorate breathing pattern in hypercapnic patients.\n\nThe aim of this study is to better understand the physiological mechanism underlying these results, assessing the respiratory mechanics in stable hypercapnic COPD patients.', 'detailedDescription': "Subjects. 10 in-patients with stable COPD and chronic hypercapnic respiratory failure with no history of neurological or chronic cardiac disease will be recruited. They need to be in a phase of clinical stability and were for a short period of rehabilitation. Patients with X-ray evidence of pulmonary edema or congestion and pulmonary infiltrate will be excluded from the study. Written consent will be obtained from all subjects, and the protocol will be approved by the Ethics Committee.\n\nMeasurements. Static and dynamic lung volumes assessed by body plethysmography (MasterLab-Jaeger, Hochberg, Germany).\n\nFlow measured with a pneumotachograph (Screenmate Box 0586, Jaeger GmbH, Hochberg, Germany), connected to a rigid mouthpiece.\n\nAirway pressure measured through tubing inserted in the mouthpiece and connected to a differential pressure transducer (Honeywell 300 cm H2O, Freeport, IL, USA). VT obtained by integration of the flow signal. The inspiratory (TI), expiratory (TE) and total breathing cycle (TTOT) duration, respiratory frequency (RR), and duty cycle (TI/TTOT) calculated as average values of 10 consecutive breaths, after 5 minutes of breathing.\n\nBaseline from peak changes in esophageal (Pes), gastric (Pga), and transdiaphragmatic (Pdi) pressures measured using the balloon-catheter technique. Pressure at the airway opening (Paw) measured via a side port.\n\nRespiratory mechanics will be assessed using Mead and Wittenberger's technique. Inspiratory pulmonary resistance (R,L) and elastance (E,L) calculated by fitting the equation of motion of a single-compartment model using multilinear regression.\n\nDynamic PEEPi (PEEPi,dyn) will be measured according to Appendini et al. The pressure time integrals of the diaphragm and the other inspiratory muscles calculated per breath (PTPdi/b and PTPes/b, respectively) and per minute (PTPdi/min and PTPes/min).\n\nSubjective ratings of dyspnea assessed during the various trials using Borg's scale.\n\nArterial blood gases (ABGs) measured in samples taken from the radial artery (ABL 550 Radiometer, Copenhagen, Denmark).\n\nThe above mentioned variables, excluding arterial blood gases recorded after 15 minutes of spontaneous breathing. At the end of this part of the study, the patients will undergo a randomized 30' trial of: 1) non-invasive mechanical ventilation (NIMV) through a nose mask for 20 minutes while they were in a sitting position. The following pressures will be used: 14 cmH2O of inspiratory aid and 4 cmH2O of expiratory-positive airway pressure. 2) HOF at the flow of 20 L/min 3) HOF at the flow of 30 L/min ECG, SaO2 will be continuosly recorded All signals collected using a personal computer equipped with an A/D board, and stored at a sampling rate of 100 Hz. The mean value of each physiological variable during the 5 minutes of recording used for analyses. Results presented as mean + standard deviation (SD). Differences between physiological parameters recorded in the 3 settings will be analysed by paired Student's T-test. Pearson's coefficient will be used to calculate to assess correlation between variables. A p value \\<0.05 chosen as the threshold of statistical significance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients\n* Chronic hypercapnic respiratory failure (pH\\>7.34 and PaCO2\\>45 mmHg)\n\nExclusion Criteria:\n\n* Cancer\n* Neurological and cardiac disease'}, 'identificationModule': {'nctId': 'NCT02363920', 'briefTitle': 'Short Term Physiological Effects of Nasal High Flow Oxygen on Respiratory Mechanics', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Short Term Physiological Effects of Nasal High Oxygen Flow vs Low Oxygen Flow and Noninvasive Ventilation (NIV) on Respiratory Mechanics', 'orgStudyIdInfo': {'id': '402015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'spontaneous breathing trial', 'description': 'the patients will be asked to breathe spontaneously using their acutal low oxygen flow', 'interventionNames': ['Device: HOF', 'Device: noninvasive mechanical ventilation (NIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HOF20', 'description': 'the patients will be asked to breathe with HOF of 20 L/min', 'interventionNames': ['Device: HOF', 'Device: noninvasive mechanical ventilation (NIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HOF30', 'description': 'the patients will be asked to breathe with HOF of 30 L/min', 'interventionNames': ['Device: HOF', 'Device: noninvasive mechanical ventilation (NIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'noninvasive mechanical ventilation (NIV)', 'description': 'the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface', 'interventionNames': ['Device: HOF', 'Device: noninvasive mechanical ventilation (NIV)']}], 'interventions': [{'name': 'HOF', 'type': 'DEVICE', 'description': 'the addition of high oxygen flow to patients breathing spontaneously', 'armGroupLabels': ['HOF20', 'HOF30', 'noninvasive mechanical ventilation (NIV)', 'spontaneous breathing trial']}, {'name': 'noninvasive mechanical ventilation (NIV)', 'type': 'DEVICE', 'description': 'the addition of a ventilatory support delivered with a oro-nasal interface', 'armGroupLabels': ['HOF20', 'HOF30', 'noninvasive mechanical ventilation (NIV)', 'spontaneous breathing trial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': "San'Orsola Malpighi Hospital, Bologna ITALY", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'stefano nava, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sant'Orsola Malpighi Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Respiratory and Critical care Unit', 'investigatorFullName': 'dr. Stefano Nava', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}