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出境医 / 临床实验 / Perioperative Pulmonary Monitoring in Major Emergency Surgery (PROMIES)

Perioperative Pulmonary Monitoring in Major Emergency Surgery (PROMIES)

Study Description
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

Condition or disease Intervention/treatment
Pulmonary Complication Cardiovascular Complication Postoperative Complications Procedure: Major emergency abdominal surgery

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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. Length of surgical incision [ Time Frame: Day 1 ]
    The length of the surgical incision [cm] will be measured on the first postoperative day

  4. Heart Rate Variability (HRV) [ Time Frame: 3 days ]
    HRV assessed preoperatively - POD3, if this is not achievable then from POD0 - POD3

  5. 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:

    • 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

  6. 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:

    • 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.

  7. 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:

    • the number of declines in saturation of 4 % (or more) lasting 20 seconds (or more) or
    • number of desaturation episodes below 90 % or
    • time (minutes( spent below 90 %,


Eligibility Criteria
Contacts and Locations
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
 (submitted: June 4, 2019)
  • 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
  • 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
  • Length of surgical incision [ Time Frame: Day 1 ]
    The length of the surgical incision [cm] will be measured on the first postoperative day
  • Heart Rate Variability (HRV) [ Time Frame: 3 days ]
    HRV assessed preoperatively - POD3, if this is not achievable then from POD0 - POD3
  • 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:
    • 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
  • 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:
    • 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.
  • 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:
    • the number of declines in saturation of 4 % (or more) lasting 20 seconds (or more) or
    • number of desaturation episodes below 90 % or
    • time (minutes( spent below 90 %,
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
  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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
  • Pulmonary Complication
  • Cardiovascular Complication
  • Postoperative Complications
Intervention Procedure: Major emergency abdominal surgery
Major emergency gastrointestinal surgery performed within 72 hours of an acute admission or an acute reoperation.
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.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 4, 2019)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Zealand University Hospital
Study Sponsor Zealand University Hospital
Collaborators Not Provided
Investigators
Study Chair: Ismail Gögenur, MD Zealand University Hospital
Principal Investigator: Jakob Burcharth, MD Zealand University Hospital
PRS Account Zealand University Hospital
Verification Date June 2019