Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT04815733
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 't is planned to recruit patients in two groups: group 1-patients who will undergo General anesthesia with deep neuromuscular block and PCV-VG; group 2-patients with partial neuromuscular block and PSVpro.\n\nRandomization of patients into two 1:1 groups will be performed by random number generation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of anaesthesia.', 'timeFrame': 'Period of time from induction to volatile anesthetic supply stop assessed up to 24 hours', 'description': 'Duration of anaesthesia.'}, {'measure': 'Procedure time', 'timeFrame': 'Period of time from intubation to extubation assessed up to 24 hours', 'description': 'Length of ventilation'}, {'measure': 'Length of stay (LOS) in the intensive care unit (ICU).', 'timeFrame': 'Period of time from ICU arrival to discharge from ICU assessed up to 1 year', 'description': 'Length of stay (LOS) in the intensive care unit (ICU).'}, {'measure': 'Time to reach an Aldrete score > 9 points after anaesthesia', 'timeFrame': 'Period of time from volatile anesthetic suplly stop to time when patient has more than 9 points according Aldrete score assessed up to 24 hours', 'description': 'Time to reach an Aldrete score \\> 9 points after anaesthesia'}, {'measure': 'Intraoperative consumption of muscle relaxant', 'timeFrame': 'Since skin incision to skin closure assessed up to 24 hours', 'description': 'mg/kg of muscle relaxant'}, {'measure': 'Intraoperative consumption of reversal agents.', 'timeFrame': 'Since skin incision to skin closure assessed up to 24 hours', 'description': 'mg/kg of reversal agents.'}, {'measure': 'Supplemental oxygen in the early postoperative period', 'timeFrame': 'Since extubation up to 24 hours after extubation', 'description': 'Duration of oxygen supply'}, {'measure': 'Quality of recovery score-40', 'timeFrame': '24 hours after surgery', 'description': 'The QoR-40 incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale.\n\nQoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).'}, {'measure': 'Changes of spirometry parameter FVC after surgery', 'timeFrame': '1 hour and 24 hours after surgery', 'description': 'FVC before surgery (L) - FVC after surgery (L)'}, {'measure': 'Changes of spirometry parameter FEV1 after surgery', 'timeFrame': '1 hour and 24 hours after surgery', 'description': 'FEV1 before surgery (L)- FEV1 after surgery (L)'}, {'measure': 'Changes of spirometry parameter FEV1/FVC after surgery', 'timeFrame': '1 hour and 24 hours after surgery', 'description': 'FEV1/FVC before surgery (percentage %) - FEV1/FVC after surgery (percentage %)'}, {'measure': 'Changes of spirometry parameter PEF after surgery', 'timeFrame': '1 hour and 24 hours after surgery', 'description': 'PEF before surgery (L/s) - PEF after surgery (L/s)'}, {'measure': 'Changes of spirometry parameter VC after surgery', 'timeFrame': '1 hour and 24 hours after surgery', 'description': 'VC before surgery (L) - VC after surgery (L)'}, {'measure': 'Changes of spirometry parameter FEV1/VC after surgery', 'timeFrame': '1 hour and 24 hours after surgery', 'description': 'FEV1/VC before surgery (percentage %) - FEV1/VC after surgery (percentage %)'}, {'measure': 'Volume of atelectasis of lungs after surgery', 'timeFrame': '24 hours after surgery', 'description': 'Volume of the lungs measure according to CT lung The volume of atelectasis is the difference in volumes of lungs before and after surgery'}, {'measure': 'The level of pain assess after surgery by Numeric Rating Scale (NRS)', 'timeFrame': '1 hour after surgery', 'description': 'No pain - 0, worst pain - 10'}, {'measure': 'The level of pain assess after surgery by Numeric Rating Scale (NRS)', 'timeFrame': '3 hours after surgery', 'description': 'No pain - 0, worst pain - 10'}, {'measure': 'The level of pain assess after surgery by Numeric Rating Scale (NRS)', 'timeFrame': '24 hours after surgery', 'description': 'No pain - 0, worst pain - 10'}, {'measure': 'Length of stay (LOS) in hospital', 'timeFrame': '28 days', 'description': 'Length of stay (LOS) in hospital'}], 'primaryOutcomes': [{'measure': 'Concentrations of biomarkers of lung injury', 'timeFrame': '1-3 hours after surgery', 'description': 'Measure concentration of Interleukin-6 (IL-6), Interleukin-8 (IL-8), tumor necrosis factor receptor I / II (sTNF rI / II)) in blood serum'}], 'secondaryOutcomes': [{'measure': 'Maximum intraoperative lactate level in the early postoperative period', 'timeFrame': '1 hour after surgery', 'description': 'Maximum intraoperative lactate level'}, {'measure': 'The maximum level of vasopressor support during surgery', 'timeFrame': 'From time of skin incision to time of skin closure assessed up to 24 hours', 'description': 'Norepinephrine consumption (mcg/kg/h)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pressure support ventilation', 'anaesthesia', 'lung injury', 'laparoscopic surgery'], 'conditions': ['Ventilator-Induced Lung Injury']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (PSVpro) versus pressure control ventilation - volume guaranteed (PCV - VG) during laparoscopic and robotic abdominal surgery.', 'detailedDescription': 'The objective of the study to evaluate the possibility and feasibility of using PSVpro during anesthesia during long-term laparoscopic and robot-assisted abdominal operations at different levels of neuromuscular block.\n\nIntervention: We plan to include 100 patients who will undergo elective long (more 2 hours) laparoscopic or abdominal robotic surgery. All patients will be randomly assigned in two groups in ratio 1:1. 1 group- deep neuromuscular block and mandatory ventilation; 2 group- partial neuromuscular block and pressure support ventilation.\n\nExpected Results. PSV may reduce the systemic inflammatory response compared to the mandatory ventilation during laparoscopic and abdominal robotic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Written consent.\n* Men and women aged 18 years or more.\n* The physical status from ASA classification I, II or III.\n* BMI \\<= 34.9 kg / m2.\n* Low risk of respiratory complications.\n* Laparoscopic surgery in the pelvis.\n\nExclusion criteria:\n\n* The physical status from ASA IV or V.\n* BMI\\> = 35 kg / m2.\n* Neuromuscular disease.\n* Allergy to Anesthetic Agents.\n* Operations on two cavities.\n* Operations on the chest cavity.'}, 'identificationModule': {'nctId': 'NCT04815733', 'briefTitle': 'Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Moscow Clinical Scientific Center'}, 'officialTitle': 'Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.', 'orgStudyIdInfo': {'id': 'MoscowCSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mandatory ventilation', 'description': 'deep neuromuscular block and mandatory ventilation (PCV-VG);', 'interventionNames': ['Procedure: Mandatory ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'Pressure support ventilation', 'description': 'partial neuromuscular block and pressure support ventilation (PSVpro).', 'interventionNames': ['Procedure: pressure support ventilation']}], 'interventions': [{'name': 'Mandatory ventilation', 'type': 'PROCEDURE', 'description': 'Use PCV-VG', 'armGroupLabels': ['Mandatory ventilation']}, {'name': 'pressure support ventilation', 'type': 'PROCEDURE', 'description': 'Use PSVpro', 'armGroupLabels': ['Pressure support ventilation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Clinical Scientific Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moscow Clinical Scientific Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Valerii Subbotin', 'investigatorAffiliation': 'Moscow Clinical Scientific Center'}}}}