Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-04-15 @ 3:47 PM
Study NCT ID:
NCT03038061
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2017-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Detection of Position of Diaphragm During Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group assignment. Approx. 20 patients during laparoscopic surgery with capnoperitoneum.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-24', 'studyFirstSubmitDate': '2017-01-28', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Position of Diaphragm Detected by Ultrasound', 'timeFrame': 'Within one laparoscopic surgery (1-3 hours)', 'description': 'Measurement in midclavicular line'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diaphragm', 'EIT', 'Laparoscopy'], 'conditions': ['Laparoscopy']}, 'referencesModule': {'availIpds': [{'url': 'http://ventilation.fbmi.cvut.cz/wp-content/uploads/2017/01/Informed-Consent-Form.pdf', 'type': 'Informed Consent Form', 'comment': 'Informed Consent'}], 'references': [{'pmid': '20608559', 'type': 'BACKGROUND', 'citation': 'Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.'}, {'pmid': '24383568', 'type': 'BACKGROUND', 'citation': 'Staehr-Rye AK, Rasmussen LS, Rosenberg J, Steen-Hansen C, Nielsen TF, Rosenstock CV, Clausen HV, Sorensen MK, VON H Regeur J, Gatke MR. Minimal impairment in pulmonary function following laparoscopic surgery. Acta Anaesthesiol Scand. 2014 Feb;58(2):198-205. doi: 10.1111/aas.12254. Epub 2014 Jan 2.'}, {'pmid': '29467544', 'type': 'DERIVED', 'citation': 'Buzkova K, Muller M, Rara A, Roubik K, Tyll T. Ultrasound detection of diaphragm position in the region for lung monitoring by electrical impedance tomography during laparoscopy. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2018 Mar;162(1):43-46. doi: 10.5507/bp.2018.005. Epub 2018 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'Position of diaphragm in the region of electrical impedance tomography measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).', 'detailedDescription': 'During laparoscopic surgery, insufflation of carbon dioxide into the peritoneal cavity is conducted in order to optimize working space for surgeons. As a side effect, the abdominal pressure alters physiological thoraco-abdominal configuration and pushes the diaphragm and lungs cranially. Since lung image acquired by electrical impedance tomography (EIT) depends on the conditions within the thorax and abdomen, it is crucial to know the diaphragm position to analyze the effect of cranial shift of diaphragm on EIT images of the thorax. Presence of diaphragm in the region of EIT measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery). The results of this study will serve during design of a subsequent study dealing with optimization of EIT electrode belt position during laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patients undergoing abdominal laparoscopic surgery\n\nExclusion Criteria:\n\n* morbid obesity\n* standard exclusion criteria for electrical impedance tomography according to the manufacturer'}, 'identificationModule': {'nctId': 'NCT03038061', 'acronym': 'UDLaS', 'briefTitle': 'Ultrasound Detection of Position of Diaphragm During Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Ultrasound Detection of Presence of Diaphragm in the Region of Lung Monitoring Using Electrical Impedance Tomography During Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'NVT108-8/104-2015/ÚVN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Patients undergoing Laparoscopic Surgery', 'interventionNames': ['Other: Patients undergoing Laparoscopic Surgery']}], 'interventions': [{'name': 'Patients undergoing Laparoscopic Surgery', 'type': 'OTHER', 'description': 'Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16902', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Military University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Karel Roubik, Prof. Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Czech Technical University in Prague'}, {'name': 'Martin Müller', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague / Military University Hospital, Prague'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Technical University in Prague', 'class': 'OTHER'}, 'collaborators': [{'name': 'Military University Hospital, Prague', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}