Perioperative Pulmonary Monitoring in Major Emergency Sur... | NCT03977337

NCT03977337

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Name	Type	Description	Arm Group Labels	Other Names
Major emergency abdominal surgery	Procedure	Major emergency gastrointestinal surgery performed within 72 hours of an acute admission or an acute reoperation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in postoperative maximal inspiratory mouth pressure from POD1 to POD3	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	Maximal expiratory mouth pressure [cmH2O] is measured on the first and third postoperative day to asses the change	3 days
Length of surgical incision	The length of the surgical incision [cm] will be measured on the first postoperative day	Day 1
Heart Rate Variability (HRV)	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)	The occurence of postoperative cardiac arrhythmia the first three days following surgery, with cardiac arrhythmia defined as: Atrial fibrillation (AF) or Atrial Flutter (AFL) or Ventricular Tachycardia (VT- both monomorphic and polymorphic types) or Recurrent sustained ventricular tachycardia (RSVT) or Ventricular fibrillation (VF) or Torsade de Pointes (TDP) or 2nd degree atrioventricular (AV) block or 3rd degree atrioventricular (AV) block	3 days
The occurence of per- and postoperative ischemic ECG changes (until POD3)	The occurence of per- and postoperative ischemic ECG changes the first three days following surgery, defined as: ST-depression ≥ 0,5 mm at the J-point in ≥ 2 contiguous leads or Inverted T waves ≥ 1 mm in ≥2 contiguous leads that have dominant R waves or ST-elevation ≥ 1 mm in ≥ 2 contiguous leads, however ST-elevation in V2-V3 ≥ 2,5 mm for males < 40 years of age in ≥ 2 contiguous leads ST-elevation in V2-V3 ≥ 2,0 mm for males ≥ 40 years of age in ≥ 2 contiguous leads ST-elevation in V2-V3 ≥ 1,5 mm for females in ≥ 2 contiguous leads) or In V2-V3: Any q wave ≥ 0,02 seconds, In other leads: Q wave ≥ 0,03 seconds and > 1 mm deep in ≥ 2 contiguous leads.

Eligibility Module

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

Name	Role	Phone	Extension	Email
Ismail Gögenur, MD	Contact	+45 26336426		igo@regionsjaelland.dk
Jakob Burcharth, MD	Contact			jbur@regionsjaelland.dk

Name	Affiliation	Role
Ismail Gögenur, MD	Zealand University Hospital	Study Chair
Jakob Burcharth, MD	Zealand University Hospital	Principal Investigator

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms