Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-04-18 @ 3:00 AM
Study NCT ID:
NCT02238561
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2014-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cost in Oxygen of Surgical Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative morbidity score (POMS)', 'timeFrame': 'Day 5 post surgery', 'description': 'The Post-Operative Morbidity Survey (POMS) is a simple outcome scale designed to record the incidence of clinically important complications - specifically complications likely to keep a patient in hospital. A POMS score performed on Day 5 is likely to be discriminative between patients who are recovering well, and those who are developing complications. POMS is easily performed, has good internal validity and is predictive of a prolonged length of stay. POMS is not a simple additive scale; however patients with POMS score of 1 or greater are highly likely to remain in hospital, whereas those with a score of 0 are likely to be able to go home.'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'estimated average length of hospital stay of 5 - 7 days', 'description': 'The number of days the patient is in hospital following surgery'}, {'measure': 'Unplanned admission to critical care.', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 - 7 days', 'description': 'We are looking at admission to critical care that was not arranged pre-operatively - a certain proportion of patients are routinely admitted to critical care because of medical co-morbidities. We are looking for those patients who were deemed fit enough not to need critical care post-operatively who subsequently need admission there, and the length of their stay there.'}, {'measure': 'Returns to the operating theatre', 'timeFrame': 'Number of events during Hospital admission (estimated average length of hospital stay of 5 - 7 days)', 'description': 'The number of times a patient has to be returned to the operating theatre during their index admission.'}, {'measure': 'Hospital readmission', 'timeFrame': 'Within 30 days of discharge from hospital', 'description': 'Number of readmissions to hospital following discharge elated to the patients surgery'}, {'measure': 'Mortality', 'timeFrame': 'Up to 30 days following hospital discharge', 'description': 'Patient mortality rate following surgery up to 30 days following discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-invasive', 'measurement of oxygen', 'consumption', 'delivery', 'post-operative complications'], 'conditions': ['Oxygen Consumption (V̇O2)', 'Oxygen Delivery (DO2)', 'Post-operative Complications']}, 'descriptionModule': {'briefSummary': 'The investigators will examine the relationship between post-operative oxygen consumption (using non-invasive measurement technology ) and complications in patients having contemporary major abdominal surgery. The investigators hypothesis is that major surgery may trigger a physiological stress response that results in an increase in post-operative metabolic demand and oxygen consumption (V̇O2) which must be met by an increased oxygen delivery (DO2).\n\n1. To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2) using indirect calorimetry in a cohort of patients\n2. To determine the feasibility of non-invasive measurement of oxygen delivery (DO2) in the same cohort using non-invasive measures of cardiac output, oxygen saturation and haemoglobin (pulse wave transit time and co-oximetry techniques)', 'detailedDescription': 'Prospective observational study of non-invasive measurements of V̇O2 and DO2 pre-operatively and at 8 time points in the 48 hours postoperatively in a cohort of 40 patients undergoing elective major abdominal surgery (both open and laparoscopic) with a pre-operative cardiopulmonary exercise testing (CPET).\n\nAs pilot work examining the relationship between post-operative oxygen consumption and complications in patients having contemporary major abdominal surgery , the investigators need to define and grade the severity of complications. The Post-Operative Morbidity Survey (POMS) is a simple outcome scale designed to record the incidence of clinically important complications - specifically complications likely to keep a patient in hospital. A POMS score performed on Day 5 is likely to be discriminative between patients who are recovering well, and those who are developing complications. POMS is easily performed, has good internal validity and is predictive of a prolonged length of stay. POMS is not a simple additive scale; however patients with POMS score of 1 or greater are highly likely to remain in hospital, whereas those with a score of 0 are likely to be able to go home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective major open or laparoscopic abdominal surgery at Plymouth Hospitals NHS Trust (PHNT)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 18 or over.\n* Undergoing elective major open or laparoscopic abdominal surgery.\n\nExclusion Criteria:\n\n* Refusal to participate\n* Requirement for post-operative ventilation\n* Requirement of inspired oxygen concentrations (FiO2) \\> 28% to maintain oxygen saturations ≥ 90%.'}, 'identificationModule': {'nctId': 'NCT02238561', 'briefTitle': 'The Cost in Oxygen of Surgical Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Plymouth NHS Trust'}, 'officialTitle': 'The Cost in Oxygen of Surgical Trauma (CO2ST) - a Feasibility Study of the Non-invasive Measurement of Oxygen Delivery and Consumption After Major Abdominal Surgery', 'orgStudyIdInfo': {'id': '14/P/123'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elective major abdominal surgery', 'description': 'Patients undergoing elective major open or laparoscopic abdominal surgery at Plymouth Hospitals National Health Service (NHS) Trust (PHNT)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Plymouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Adam Kimble, BSc(Hons), MSc, MBBS, MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Plymouth NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}