| Condition or disease | Intervention/treatment |
|---|---|
| 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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 | ||||||