Pulmonary ComplicationPROMIESNCT03977337
Perioperative Pulmonary Monitoring in Major Emergency Surgery
An observational study of Pulmonary Complication and Cardiovascular Complication, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Complication, Cardiovascular Complication, Postoperative Complications
- What is being tested?
- Major emergency abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Nov 2018to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the department of Surgery, Zealand University Hospital, Denmark.
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Jakob Burcharth, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Surgery, Zealand University Hospital, Denmark.
Køge, 4600
Ismail Gögenur, MD, +45 26336426, igo@regionsjaelland.dk
Jakob Burcharth, MD, jbur@regionsjaelland.dk
About this study
Official title: 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
- Being tested
- Major emergency abdominal surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major emergency abdominal surgeryProcedure or surgery
Major emergency gastrointestinal surgery performed within 72 hours of an acute admission or an acute reoperation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 days
Length of surgical incision
The length of the surgical incision [cm] will be measured on the first postoperative day
Measured: Day 1
Heart Rate Variability (HRV)
HRV assessed preoperatively - POD3, if this is not achievable then from POD0 - POD3
Measured: 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
Measured: 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.
Measured: 3 days
The occurence of postoperative hypoxemia during the first three postoperative 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 %,
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start29 Nov 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ismail Gögenur, MD, Study chair, Zealand University HospitalJakob Burcharth, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977337
- Sponsor's protocol ID
- PROMIES
- Acronym
- PROMIES
- Status last verified
- Jun 2019
- First submitted
- 14 Jan 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pulmonary Monitoring in Major Emergency Surgery -the PROMIES Project
- ClinicalTrials.gov ID
- NCT03977337
- Acronym / sponsor ID
- PROMIES / PROMIES
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the department of Surgery, Zealand University Hospital, Denmark.
Key inclusion criteria (14 listed)
- Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
- Major gastrointestinal surgery on the gastrointestinal tract.
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Major emergency abdominal surgeryMajor emergency gastrointestinal surgery performed within 72 hours of an acute admission or an acute reoperation. | Procedure or surgery | – |
Primary outcome
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 %,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob Burcharth, MD contact
Ismail Gögenur, MD study chair
Zealand University Hospital
Jakob Burcharth, MD principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Complication and Cardiovascular Complication, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ismail Gögenur, MD (+45 26336426, igo@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative maximal inspiratory mouth pressure from POD1 to POD3 (time frame: 3 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.