- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03977337
Perioperative Pulmonary Monitoring in Major Emergency Surgery (PROMIES)
Perioperative Pulmonary Monitoring in Major Emergency Surgery -the PROMIES Project
- Describe the incidence of postoperative hypoxemia after major emergency abdominal surgery as well as correlate this to clinical outcomes.
- Investigate the association between postoperative pulmonary complications and respiratory muscle dysfunction.
- Investigate the association between the length and type of incision as well as the distance to the xiphoid process and respiratory muscle dysfunction.
- Investigate the association between postoperative hypoxemia, myocardial ischemia and ischemic electrocardiographic (ECG) changes within three days of major emergency abdominal surgery
- Describe the incidence of postoperative cardiac arrhythmias within three days of major emergency abdominal surgery and the association with postoperative cardiovascular complications within 30 days, 90 days and 1 year of surgery.
- Describe the association between HRV and postoperative cardiovascular and non-cardiovascular complications within 30 days, 90 days and 1 year of surgery
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Køge, Denmark, 4600
- Recruiting
- Department of Surgery, Zealand University Hospital, Denmark.
-
Contact:
- Ismail Gögenur, MD
- Phone Number: +45 26336426
- Email: igo@regionsjaelland.dk
-
Contact:
- Jakob Burcharth, MD
- Email: jbur@regionsjaelland.dk
-
Sub-Investigator:
- Adam Alexander Berkfors, Bsc
-
Sub-Investigator:
- Ellen Bjerrum, Bsc
-
Principal Investigator:
- Jakob Burcharth, MD
-
Principal Investigator:
- Sarah Busch, MD
-
Principal Investigator:
- Ismail Gögenur, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
- Major gastrointestinal surgery on the gastrointestinal tract.
This will include:
- Open, laparoscopic, or laparoscopically-assisted procedures
- Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischemia, abdominal abscess, bleeding or obstruction
- Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
- Washout/evacuation of intra-peritoneal hematoma
- Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair)
- Bowel resection/repair due to obstructing/incarcerated incisional hernias provided the presentation and findings were acute
- Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases)
- Laparoscopic/Open adhesiolysis
- Return to theatre for repair of fascial dehiscence
- Any reoperation/return to theatre meeting the criteria above is included
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:
- Not capable of giving informed consent after oral and written information
- Previously included in the trial
- Elective laparoscopy
- Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
- Appendectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
- Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract (All surgery involving the appendix or gallbladder, including any surgery relating to complications such as abscess or bile leak is excluded)
- Non-elective hernia repair without bowel resection.
- Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
- Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
- Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma
- Laparotomy/laparoscopy for esophageal pathology
- Laparotomy/laparoscopy for pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in postoperative maximal inspiratory mouth pressure from POD1 to POD3
Time Frame: 3 days
|
Maximal inspiratory mouth pressure [cmH2O] is measured on the first and third postoperative day to asses the change
|
3 days
|
Change in postoperative maximal expiratory mouth pressure from POD1 to POD3
Time Frame: 3 days
|
Maximal expiratory mouth pressure [cmH2O] is measured on the first and third postoperative day to asses the change
|
3 days
|
Length of surgical incision
Time Frame: Day 1
|
The length of the surgical incision [cm] will be measured on the first postoperative day
|
Day 1
|
Heart Rate Variability (HRV)
Time Frame: 3 days
|
HRV assessed preoperatively - POD3, if this is not achievable then from POD0 - POD3
|
3 days
|
The occurence of per- and postoperative cardiac arrhythmias (until POD3)
Time Frame: 3 days
|
The occurence of postoperative cardiac arrhythmia the first three days following surgery, with cardiac arrhythmia defined as:
|
3 days
|
The occurence of per- and postoperative ischemic ECG changes (until POD3)
Time Frame: 3 days
|
The occurence of per- and postoperative ischemic ECG changes the first three days following surgery, defined as:
|
3 days
|
The occurence of postoperative hypoxemia during the first three postoperative days
Time Frame: 3 days
|
The occurence of postoperative hypoxemia during the first three postoperative days, defined as:
|
3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ismail Gögenur, MD, Zealand University Hospital
- Principal Investigator: Jakob Burcharth, MD, Zealand University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROMIES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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