Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT04534933
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2020-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Flow Controlled Ventilation in Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018467', 'term': 'Positive-Pressure Respiration, Intrinsic'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'controlled, prospective'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-08-31', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'paO2 / FiO2 ratio (Horowitz Index)', 'timeFrame': 'after 30 minutes of one lung ventilation', 'description': 'Comparison of oxygenation assessed by arterial partial pressure of oxygen (paO2) / fraction of inspired oxygen (FiO2)'}], 'secondaryOutcomes': [{'measure': 'decarboxylation (paCO2)', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Required respiratory minute volume to achieve a taregeted paCO2 of 35-45 mmHg during two lung ventilation and 40-60 mmHg during one lung ventilation'}, {'measure': 'venous admixture (Qs / Qt)', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of calculated venous admixure from arterial and central venous blood gas analysis'}, {'measure': 'respiratory minute volume', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of respiratory minute volume'}, {'measure': 'respiratory rate', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of respiratory rate'}, {'measure': 'tidal volume', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of applied tidal volume'}, {'measure': 'positive end-expiratory pressure', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of set positive end-expiratory pressure'}, {'measure': 'peak pressure', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of set peak pressure'}, {'measure': 'driving pressure', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of resulting driving pressure'}, {'measure': 'respiratory compliance', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of measured respiratory compliance'}, {'measure': 'applied mechanical power', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of calculated applied mechanical power from the ventilator'}, {'measure': 'respiratory resistance', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of measured respiratory resistance'}, {'measure': 'heart rate', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of measured heart rate'}, {'measure': 'mean arterial pressure', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of measured mean arterial pressure'}, {'measure': 'central venous pressure', 'timeFrame': 'during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)', 'description': 'Comparison of measured central venous pressure'}, {'measure': 'Concentration of plamatic cytokine levels', 'timeFrame': 'preoperative before induction of general anesthesia and postoperative at PACU admission and 1 hour thereafter', 'description': 'Plasmatic cytokine level of IL-6, IL-8, IL-10 and TNF-alpha will be assessed pre- (before induction of general anesthesia) and postoperative (ad PACU admission and 60 minutes therafter).'}, {'measure': 'length of PACU stay', 'timeFrame': 'Time from PACU admission to transfer to a general ward in hours', 'description': 'Duration of the patient at the post-anesthesia care unit (PACU)'}, {'measure': 'length of hospital stay', 'timeFrame': 'days from surgery to hospital discharge', 'description': 'Comparison of length of hospital stay after thoracic surgery'}, {'measure': 'postoperative pulmonary complications (PPC)', 'timeFrame': 'until hospital discharge or day 30 of hospital stay', 'description': 'PPC will be assessd daily until hospital discharge or day 30 of hospital stay from the medical records during the follow-up period. The European Perioperative Clinical Outcome (EPCO) definition will be used to assess the occurrence of PPC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['flow controlled ventilation', 'pressure controlled ventilation', 'thoracic surgery', 'one lung ventilation'], 'conditions': ['Positive-Pressure Respiration, Intrinsic']}, 'referencesModule': {'references': [{'pmid': '25058504', 'type': 'BACKGROUND', 'citation': 'Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.'}, {'pmid': '29734208', 'type': 'BACKGROUND', 'citation': 'Schmidt J, Wenzel C, Mahn M, Spassov S, Cristina Schmitz H, Borgmann S, Lin Z, Haberstroh J, Meckel S, Eiden S, Wirth S, Buerkle H, Schumann S. Improved lung recruitment and oxygenation during mandatory ventilation with a new expiratory ventilation assistance device: A controlled interventional trial in healthy pigs. Eur J Anaesthesiol. 2018 Oct;35(10):736-744. doi: 10.1097/EJA.0000000000000819.'}, {'pmid': '31828755', 'type': 'BACKGROUND', 'citation': 'Weber J, Schmidt J, Straka L, Wirth S, Schumann S. Flow-controlled ventilation improves gas exchange in lung-healthy patients- a randomized interventional cross-over study. Acta Anaesthesiol Scand. 2020 Apr;64(4):481-488. doi: 10.1111/aas.13526. Epub 2019 Dec 30.'}, {'pmid': '31992213', 'type': 'BACKGROUND', 'citation': 'Weber J, Straka L, Borgmann S, Schmidt J, Wirth S, Schumann S. Flow-controlled ventilation (FCV) improves regional ventilation in obese patients - a randomized controlled crossover trial. BMC Anesthesiol. 2020 Jan 28;20(1):24. doi: 10.1186/s12871-020-0944-y.'}]}, 'descriptionModule': {'briefSummary': 'This trial investigates effects of individualized (by compliance guided pressure settings) flow-controlled ventilation compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation.', 'detailedDescription': 'Flow-controlled ventilation (FCV) is a novel ventilation method with promising first results in porcine studies as well as clinical cross-over trials. A more efficient and maybe lung protective ventilation strategy would be crucial in the challenging situation of one lung ventilation during thoracic surgery, when the whole gas exchange has to be provided by just one half of the lungs.\n\nThus, individualized FCV, based on compliance guided pressure settings, will be compared to standard of pressure-controlled ventilation in thoracic surgery requiring one lung ventilation in a randomized controlled trial. Based on previous preclinical trials an improvement of oxygenation by 15% will be expected and in order to transfer the preclinical results to humans oxygenation assessed by paO2 / FiO2 ratio after 30 minutes of one lung ventilation is the main primary outcome parameter of this study. Furthermore, improved recruitment of lung tissue due to controlled expiratory flow in FCV will be anticipated without the need of recruitment maneuvers, which may cause deleterious effects on lung tissue. Accordingly any recruitment maneuvers will be omitted in the FCV group.\n\nThe investigators hypothesize that improved gas exchange in terms of improved oxygenation and reduced respiratory minute volume required for CO2-removal will be achieved with FCV compared to PCV. Secondary outcome parameters such as the incidence of postoperative pulmonary complications will be additionally assessed in order to plan future studies with clinically relevant outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects ≥ 18 years\n* Body weight ≥ 40 kg\n* Elective thoracic surgery requiring OLV\n* ASA I-III\n* Written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Female subjects known to be pregnant\n* Known participation in another interventional clinical trial\n* high pulmonary risk (ppo FEV1\\<20ml/kg in male or ppo FEV1\\<18ml/kg in female)\n* Empyema evacuation or signs of pulmonary infection\n* High grade CMP (EF\\<30%)'}, 'identificationModule': {'nctId': 'NCT04534933', 'briefTitle': 'Flow Controlled Ventilation in Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Thoracic Surgery With One Lung Ventilation - a Prospective, Randomized Clinical Study', 'orgStudyIdInfo': {'id': '1014/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FCV', 'description': 'Artificial ventilation will be performed with individualized flow-controlled ventilation (Evone, Ventinova Medical B.V., Eindhoven, the Netherlands) during thoracic surgery. Individualization will be established by compliance guided end-expiratory and peak pressure setting during two lung ventilation as well as one lung ventilation, flow setting will be adjusted to secure normocapnia during two lung ventilation and the targeted paCO2 during one lung ventilation is 40-60 mmHg, provided that pH \\>7.2. The I:E ratio will be set to 1:1. The FiO2 will be set to achieve normoxia during two lung ventilation, increased to 100% before lung isolation and after 15 minutes of one-lung ventilation again decreased to secure normoxia or mild hyperoxia (target paO2 of 75-120 mmHg). No recruitment maneuver will be performed for re-inflation of the separated lung and after regain of spontaneous breathing tracheal extubation performed in the operating room.', 'interventionNames': ['Device: Evone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCV', 'description': 'Artificial ventilation will be performed with pressure-controlled ventilation (Primus, Dräger, Lübeck, Germany) during thoracic surgery. Peak pressure will be set to achieve a tidal volume of 6-8 ml/kg predicted body weight (PBW) at a compliance titrated positive end-expiratory pressure during two lung ventilation and the tidal volume will be reduced to 4-6 ml/kg PBW during one lung ventilation. Respiratory rate will be set to maintain normocapnia during two lung ventilation and a targeted paCO2 level during one lung ventilation of 40-60 mmHg, provided that pH \\> 7.2. The I:E ratio will be set to 1:1.5 except extension of expiration is necessary in order to avoid air trapping. The FiO2 will be set to achieve normoxia during two lung ventilation, increased to 100% before lung isolation until 15 minutes of one lung ventilation and decreased thereafter to achieve a targeted paO2 level of 75-120 mmHg. For re-inflation a manual recruitment maneuver will be performed under surgical guidance.', 'interventionNames': ['Device: Primus']}], 'interventions': [{'name': 'Evone', 'type': 'DEVICE', 'description': 'Airway ventilation device', 'armGroupLabels': ['FCV']}, {'name': 'Primus', 'type': 'DEVICE', 'description': 'Airway ventilation device', 'armGroupLabels': ['PCV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Judith Martini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Innsbruck, Dept. of Anaesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}