Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-13 @ 8:09 PM
Study NCT ID:
NCT03751605
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2018-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indirect Measurement of Respiratory Quotient in Unipulmonary Ventilation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2018-11-21', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indirect respiratory quotient', 'timeFrame': 'during surgery'}], 'secondaryOutcomes': [{'measure': 'occurrence of at least one post-operative complication', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'the aim is to predict the occurrence of at least one complication with the use of indirect respiratory quotient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['unipulmonary ventilation, complications, respiratory quotient.'], 'conditions': ['Respiratory Quotient Measurement']}, 'descriptionModule': {'briefSummary': 'The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis. A study has been conducted in our department to demonstrate the ability of the indirectly measured respiratory quotient (RQ) from the inspired and exhaled breath analysis of the anesthetic respirator to predict the onset of anaerobic metabolism and postoperative complications in the operating room.\n\nUnipulmonary ventilation is the rule in thoracic surgery: it improves surgical exposure and protects the operated lung.\n\nHowever, no study has examined the impact of these mechanisms on the indirect measurement of RQ in unipulmonary ventilation. The main objective of our work is to validate indirect RQ measurement during unipulmonary ventilation. The secondary objective was to assess the predictability of postoperative complications of indirect QR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n* Age\\>18 years old\n* Adults admitted to the operating room for thoracic surgery requiring unipulmonary ventilation\n\nExclusion Criteria:\n\n* Cardiac surgery\n* Laparoscopy\n* Preoperative oxygen therapy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years old\n* Adults admitted to the operating room for thoracic surgery requiring unipulmonary ventilation\n\nExclusion Criteria:\n\n* Cardiac surgery\n* Laparoscopy\n* Preoperative oxygen therapy'}, 'identificationModule': {'nctId': 'NCT03751605', 'briefTitle': 'Indirect Measurement of Respiratory Quotient in Unipulmonary Ventilation.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Validation of the Respiratory Quotient Measurement Measured Indirectly in Unipulmonary Ventilation (UNIQ Study)', 'orgStudyIdInfo': {'id': 'PI2018_843_0047'}}, 'armsInterventionsModule': {'interventions': [{'name': 'unipulmonary ventilation', 'type': 'PROCEDURE', 'description': 'observational study based on the computation of respiratory quotient in patient cohort treated by unipulmonary ventilation in routine thoracic surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}