Condition or disease | Intervention/treatment |
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Pulmonary Complication Cardiovascular Complication Postoperative Complications | Procedure: Major emergency abdominal surgery |
Study Type : | Observational |
Estimated Enrollment : | 350 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Perioperative Pulmonary Monitoring in Major Emergency Surgery -the PROMIES Project |
Actual Study Start Date : | November 29, 2018 |
Estimated Primary Completion Date : | November 30, 2019 |
Estimated Study Completion Date : | November 30, 2019 |
The occurence of postoperative cardiac arrhythmia the first three days following surgery, with cardiac arrhythmia defined as:
The occurence of per- and postoperative ischemic ECG changes the first three days following surgery, defined as:
The occurence of postoperative hypoxemia during the first three postoperative days, defined as:
Tracking Information | |||||||
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First Submitted Date | January 14, 2019 | ||||||
First Posted Date | June 6, 2019 | ||||||
Last Update Posted Date | June 6, 2019 | ||||||
Actual Study Start Date | November 29, 2018 | ||||||
Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Perioperative Pulmonary Monitoring in Major Emergency Surgery | ||||||
Official Title | Perioperative Pulmonary Monitoring in Major Emergency Surgery -the PROMIES Project | ||||||
Brief Summary |
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Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Probability Sample | ||||||
Study Population | Patients admitted to the department of Surgery, Zealand University Hospital, Denmark. | ||||||
Condition |
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Intervention | Procedure: Major emergency abdominal surgery
Major emergency gastrointestinal surgery performed within 72 hours of an acute admission or an acute reoperation.
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Study Groups/Cohorts | Not Provided | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Unknown status | ||||||
Estimated Enrollment |
350 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | November 30, 2019 | ||||||
Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
This will include:
If multiple procedures (primary surgery or reoperation) are performed on different anatomical sites within the abdominal/pelvic cavity, the patient would be included if the major procedure is general surgical. Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Denmark | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03977337 | ||||||
Other Study ID Numbers | PROMIES | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Zealand University Hospital | ||||||
Study Sponsor | Zealand University Hospital | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Zealand University Hospital | ||||||
Verification Date | June 2019 |