Clinical trial NCT03977337: Perioperative Pulmonary Monitoring in Major Emergency Surgery
Official title: Perioperative Pulmonary Monitoring in Major Emergency Surgery -the PROMIES Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Complication
Cardiovascular Complication
Postoperative Complications
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the department of Surgery, Zealand University Hospital, Denmark.

Brief summary: 1. Describe the incidence of postoperative hypoxemia after major emergency abdominal surgery as well as correlate this to clinical outcomes.
2. Investigate the association between postoperative pulmonary complications and respiratory muscle dysfunction.
3. Investigate the association between the length and type of incision as well as the distance to the xiphoid process and respiratory muscle dysfunction.
4. Investigate the association between postoperative hypoxemia, myocardial ischemia and ischemic electrocardiographic (ECG) changes within three days of major emergency abdominal surgery
5. 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.
6. Describe the association between HRV and postoperative cardiovascular and non-cardiovascular complications within 30 days, 90 days and 1 year of surgery


Eligibility criteria: 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

Primary outcomes:
measure: Change in postoperative maximal inspiratory mouth pressure from POD1 to POD3
timeFrame: 3 days
measure: Change in postoperative maximal expiratory mouth pressure from POD1 to POD3
timeFrame: 3 days
measure: Length of surgical incision
timeFrame: Day 1
measure: Heart Rate Variability (HRV)
timeFrame: 3 days
measure: The occurence of per- and postoperative cardiac arrhythmias (until POD3)
timeFrame: 3 days
measure: The occurence of per- and postoperative ischemic ECG changes (until POD3)
timeFrame: 3 days
measure: The occurence of postoperative hypoxemia during the first three postoperative days
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of Surgery, Zealand University Hospital, Denmark.
Study officials:
affiliation: Zealand University Hospital
name: Ismail Gögenur, MD
role: STUDY_CHAIR
affiliation: Zealand University Hospital
name: Jakob Burcharth, MD
role: PRINCIPAL_INVESTIGATOR
References: