Cardiopulmonary DiseasePreOPFOCUSNCT03501927
Focused Cardiac Ultrasound in Surgery
A study testing FOCUS (focused cardiac ultrasound) in people with Cardiopulmonary Disease and Surgery, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Mortality and morbidity remain high after non-cardiac surgery. Known risk factors include age, high ASA grade and emergency surgery. Point-of-care focused cardiac ultrasound may elucidate pathology and potential hemodynamic compromise unknown to handling physicians. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiopulmonary Disease, Surgery, Morality
- What is being tested?
- FOCUS (focused cardiac ultrasound)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteDenmark
- Study dates
- 7 May 2018to 1 Sep 2020
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients scheduled for emergency (< 6 hours) or urgent surgery (< 24 hours)15
- General or neuro-axial anaesthesia planned at the first anesthetic visit
- ASA classification 3 or 4.
- Age ≥ 65 years
Who cannot join
- Previous surgery performed during current hospital admission (including transfers from other hospitals than Randers Regional Hospital/Hospital of Southern Jutland)
- Low risk surgery or expected surgery time < 30 minutes or endoscopies.
- Lack of consent from patient or proxy (in case of patient mental incapacity)
- Previous participation in the study. Pre-operative FOCUS not possible for logistical reasons or due to requirement for immediate surgery
- Drop-out Criteria:
- Patients who refuse participation after formal inclusion will drop out.
- Patients converted from a primary anaesthetic plan of general/neuro-axial anaesthesia to regional anaesthesia will not drop-out. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Pre-operative Point-of-Care Focused Cardiac Ultrasound on Patient Outcome - a Prospective, Randomized, Clinical Study (PreOPFOCUS)
Mortality and morbidity remain high after non-cardiac surgery. Known risk factors include age, high ASA grade and emergency surgery. Point-of-care focused cardiac ultrasound may elucidate pathology and potential hemodynamic compromise unknown to handling physicians. This study aims to investigate the effects of focused cardiac ultrasound in high-risk patients undergoing non-cardiac surgery with respect to clinical endpoints.
Read the detailed description
In non-cardiac surgery major risk factors for morbidity and mortality include ASA classification, age, acute surgery and pre-existing cardiopulmonary disease. These risk factors are sometimes readily available and, along with the type of surgery, allow anaesthesiologists to tailor anaesthetic drugs, fluid therapy and monitoring to the individual patient need. However, cardiopulmonary disease may be occult or masked by other patient-related incapacities. Hence, identification of cardiopulmonary disease is an important priority during the pre-operative anaesthesia evaluation. Routine pre-operative anaesthesia evaluation includes screening with auscultation, blood tests and often electrocardiography. However, these exams are insensitive for detecting cardiopulmonary diseases that may be life threatening during anaesthesia, including ischaemia, heart valve disease and left ventricular hypertrophy.
Point-of-care focused cardiac ultrasound (FOCUS) is claimed to be an effective method for filling out this obvious gap in rapid diagnostic capability, as FOCUS can detect both structural and functional cardiac disease as well as pleural effusion. FOCUS performed by anaesthesiologists can identify unknown pathologies in surgical patients and identification of these enables prediction of perioperative morbidity. Although pre-operative FOCUS has been shown to alter anaesthetic patient management, it remains unclear whether the application of FOCUS actually impacts patient outcome.
This study aims to clarify whether pre-operative FOCUS changes clinical outcomes in high-risk patients undergoing acute, non-cardiac surgery.
The hypothesis of the study is that pre-operative FOCUS reduces the fraction of patients admitted to hospital for more than 10 days or are dead within 30 days after high risk, non-cardiac surgery.
- Conditions
- Cardiopulmonary Disease, Surgery, Morality, Complication
- Being tested
- FOCUS (focused cardiac ultrasound)
- Keywords
- Ultrasound, FOCUS, Surgery, Anesthesia
- Medical subject headings
- Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCUS (focused cardiac ultrasound)Diagnostic test
A ultrasound of the heart and pleura will be performed. This provide information on
- Left ventricular systolic function
- Left ventricular diastolic function
- Right ventricular systolic function
- Right ventricular pressure overload
- Biventricular sizes
- Pathology of the mitral- and aortic valves
- Pericardial fluid
- Gross fluid status
- Pleural effusion
| Study group | Role | What they receive |
|---|---|---|
| FOCUS (focused cardiac ultrasound) | Active comparator | Patients allocated to FOCUS will receive a preoperative FOCUS examination in conjunction with a standard anesthetic preoperative evaluation. Receives: Diagnostic Test: FOCUS (focused cardiac ultrasound) |
| Control | No intervention | Patients allocated til control arm will receive a standard anesthetic preoperative evaluation according to hospitals' standards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days
Measured: 30 days after surgery
Secondary outcomes (35)
Length of stay
Defined as the number of days admitted to hospital from the date of surgery (included)
Measured: Up to 180 days after surgery
Re-admissions to hospital
Re-admissions to hospital (no) within 90 days (no)
Measured: Up to 90 days after surgery
Length of stay
Length of stay including re-admissions to hospital within 90 days
Measured: Up to 90 days after surgery
Death ≤ 30 days & ≤ 90 days
Death ≤ 30 days \& ≤ 90 days (no)
Measured: Up to 90 days after surgery
Intensive care treatment
Intensive care treatment (hours)
Measured: Up to 90 days after surgery
Postoperative ventilator treatment
Postoperative ventilator treatment (hours)
Measured: Up to 90 days after surgery
Admittance to the post-operative care unit
Admittance to the post-operative care unit (hours)
Measured: Up to 1 day after surgery
Development of acute kidney injury
Development of acute kidney injury (AKI) (stage 1,2 \& 3, defined by th KDIGO creatinine criteria within seven days of surgery)
Measured: Within 7 days of surgery
Accumulated intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs.
Accumulated intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs (mg).
Measured: From start of anaesthesia til end of anaesthesia
Accumulated fluid balance
Accumulated fluid balance until end of surgery
Measured: From start of anaesthesia til end of anaesthesia
Echocardiography
Formal echocardiography's (1) ordered and (2) actually performed in total and secondarily due to preoperative FOCUS (no).
Measured: From anaeshetic visit to start of anaesthesia
Surgery cancellations due to preoperative FOCUS
Surgery cancellations in total and secondarily due to preoperative FOCUS (no)
Measured: Before start of anaeshesia
Surgery postponements due to preoperative FOCUS
Surgery postponements in total and secondarily due to preoperative FOCUS (no).
Measured: Within 7 days of preoperative anaesthetic visit
Surgery changes
Surgery changes in total and secondarily due to preoperative FOCUS (no, type).
Measured: From FOCUS to the start of surgery
Perioperative myocardial damage
Troponin I
Measured: From the day before surgery to the day following surgery
Changes in anesthetic practice
Changes in anesthetic practice/perianesthetic care DUE to preoperative FOCUS. Includes both step up/step down
Measured: From start of anaesthesia to start of surgery
Echocardiography
Formal echocardiographies ordered prior to surgery
Measured: From FOCUS to start of surgery
Volume
Volume infusion prior to anesthesia. Both in total and facilitated by FOCUS
Measured: From FOCUS to the start of anaesthesia
Anaesthesia type
Conversion of Anaesthesia type from primary anesthetic visit to actually performed. Both in total and facilitated by FOCUS.
Measured: From FOCUS to the start of anaesthesia
Anaesthetic monitoring
Step up and step down in anesthetic monitoring. Both in total and facilitated by FOCUS. Includes extra intravenous lines inserted including central venous catheters, arterial lines inserted, change to 5-lead ECG, vasopressors infused with anaesthetic induction
Measured: From start of anaesthesia to end of anaesthesia
Anesthesia time
Anesthesia time
Measured: From start of anaesthesia to end of anaesthesia
Surgery time
Surgery time
Measured: From start of surgery to end of surgery
Cardiogenic pulmonary oedema
Cardiogenic pulmonary oedema within 30 days of surgery
Measured: From start of anaesthesia to 30 days after surgery
New onset cardiac arrhythmia
New onset cardiac arrhythmia of any kind.
Measured: From start of anaesthesia to 30 days after surgery
Non-fatal cardiac arrest
Non-fatal cardiac arrest regardless of cause.
Measured: From start of anaesthesia to 30 days after surgery
Anastomotic breakdown
Anastomotic breakdown (deep or superficial)
Measured: From start of anaesthesia to 30 days after surgery
Myocardial infarction
Myocardial infarction as defined by the universal criteria
Measured: From start of anaesthesia to 30 days after surgery
Stroke
Cerebral stroke
Measured: From start of anaesthesia to 30 days after surgery
Pulmonary embolism
Pulmonary embolism with radiological confirmation
Measured: From start of anaesthesia to 30 days after surgery
Postoperative haemorrhage
Postoperative haemorrhage demanding blood transfusion
Measured: From end of anaesthesia to 30 days after surgery
Gastrointestinal bleed
Gastrointestinal bleed
Measured: From start of anaesthesia to 30 days after surgery
Pneumonia
Pneumonia
Measured: From start of anaesthesia to 30 days after surgery
Surgical site infection
Surgical site infection (superficial or deep)
Measured: From end of anaesthesia to 30 days after surgery
Urinary tract infection
Urinary tract infection
Measured: From end of anaesthesia to 30 days after surgery
Infektion, source unknown
Infektion, source unknown.
Measured: From end of anaesthesia to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start7 May 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Why it stopped: Impossible patient inclusion due to the COVID-10 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Preoperative point-of-care focused cardiopulmonary ultrasound (FOCUS) Patients are to be randomised in a 1:1 ratio to either 1) FOCUS prior to anaesthesia or 2) no FOCUS performed (standard treatment).
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital, Aabenraa Hospital
- Responsible party
- Principal investigator, Jan Pallesen, Randers Regional Hospital
- Investigators
- Jan Pallesen, MD, Principal investigator, Randers Regional HospitalRajesh Bhavsar, MD, Principal investigator, Aabenraa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501927
- Sponsor's protocol ID
- PreOPFOCUS
- Acronym
- PreOPFOCUS
- Status last verified
- Apr 2021
- First submitted
- 20 Feb 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and statistical plan will be published in a peer-reviewed journal. Study results will be made available at a freely accessible online site.
Publications
M Saklad. Grading patients for surgical procedures. Anesthesiology 1941;2:281-4
Davenport DL, Ferraris VA, Hosokawa P, Henderson WG, Khuri SF, Mentzer RM Jr. Multivariable predictors of postoperative cardiac adverse events after general and vascular surgery: results from the patient safety in surgery study. J Am Coll Surg. 2007 Jun;204(6):1199-210. doi: 10.1016/j.jamcollsurg.2007.02.065.
PubMed 17544078Kheterpal S, O'Reilly M, Englesbe MJ, Rosenberg AL, Shanks AM, Zhang L, Rothman ED, Campbell DA, Tremper KK. Preoperative and intraoperative predictors of cardiac adverse events after general, vascular, and urological surgery. Anesthesiology. 2009 Jan;110(1):58-66. doi: 10.1097/ALN.0b013e318190b6dc.
PubMed 19104171Khuri SF, Henderson WG, DePalma RG, Mosca C, Healey NA, Kumbhani DJ; Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005 Sep;242(3):326-41; discussion 341-3. doi: 10.1097/01.sla.0000179621.33268.83.
PubMed 16135919Asch FM, Shah S, Rattin C, Swaminathan S, Fuisz A, Lindsay J. Lack of sensitivity of the electrocardiogram for detection of old myocardial infarction: a cardiac magnetic resonance imaging study. Am Heart J. 2006 Oct;152(4):742-8. doi: 10.1016/j.ahj.2006.02.037.
PubMed 16996851Olive KE, Grassman ED. Mitral valve prolapse: comparison of diagnosis by physical examination and echocardiography. South Med J. 1990 Nov;83(11):1266-9. doi: 10.1097/00007611-199011000-00008.
PubMed 2237552Beyerbacht HP, Bax JJ, Lamb HJ, van der Laarse A, Vliegen HW, de Roos A, Zwinderman AH, van der Wall EE. Evaluation of ECG criteria for left ventricular hypertrophy before and after aortic valve replacement using magnetic resonance imaging. J Cardiovasc Magn Reson. 2003 Jul;5(3):465-74. doi: 10.1081/jcmr-120022262.
PubMed 12882077Holm JH, Frederiksen CA, Juhl-Olsen P, Sloth E. Perioperative use of focus assessed transthoracic echocardiography (FATE). Anesth Analg. 2012 Nov;115(5):1029-32. doi: 10.1213/ANE.0b013e31826dd867. Epub 2012 Oct 9. No abstract available.
PubMed 23051882Botker MT, Vang ML, Grofte T, Sloth E, Frederiksen CA. Routine pre-operative focused ultrasonography by anesthesiologists in patients undergoing urgent surgical procedures. Acta Anaesthesiol Scand. 2014 Aug;58(7):807-14. doi: 10.1111/aas.12343. Epub 2014 May 28.
PubMed 24865842Kratz T, Campo Dell'Orto M, Exner M, Timmesfeld N, Zoremba M, Wulf H, Steinfeldt T. Focused intraoperative transthoracic echocardiography by anesthesiologists: a feasibility study. Minerva Anestesiol. 2015 May;81(5):490-6. Epub 2014 Sep 15.
PubMed 25220551Cowie B. Focused transthoracic echocardiography predicts perioperative cardiovascular morbidity. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):989-93. doi: 10.1053/j.jvca.2012.06.031. Epub 2012 Aug 22.
PubMed 22920841Canty DJ, Royse CF, Kilpatrick D, Williams DL, Royse AG. The impact of pre-operative focused transthoracic echocardiography in emergency non-cardiac surgery patients with known or risk of cardiac disease. Anaesthesia. 2012 Jul;67(7):714-20. doi: 10.1111/j.1365-2044.2012.07118.x. Epub 2012 Mar 27.
PubMed 22452367Kratz T, Steinfeldt T, Exner M, Dell Orto MC, Timmesfeld N, Kratz C, Skrodzki M, Wulf H, Zoremba M. Impact of Focused Intraoperative Transthoracic Echocardiography by Anesthesiologists on Management in Hemodynamically Unstable High-Risk Noncardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):602-609. doi: 10.1053/j.jvca.2016.11.002. Epub 2016 Nov 2.
PubMed 28089598Moore CL. Does Ultrasound Improve Clinical Outcomes? Prove It. Crit Care Med. 2015 Dec;43(12):2682-3. doi: 10.1097/CCM.0000000000001325. No abstract available.
PubMed 26575658Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN; American College of Cardiology; American Heart Association. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014 Dec 9;64(22):e77-137. doi: 10.1016/j.jacc.2014.07.944. Epub 2014 Aug 1. No abstract available.
PubMed 25091544
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pre-operative Point-of-Care Focused Cardiac Ultrasound on Patient Outcome - a Prospective, Randomized, Clinical Study (PreOPFOCUS)
- ClinicalTrials.gov ID
- NCT03501927
- Acronym / sponsor ID
- PreOPFOCUS / PreOPFOCUS
- Conditions
- Cardiopulmonary Disease, Surgery, Morality, Complication
- Keywords
- Ultrasound, FOCUS, Surgery, Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Impossible patient inclusion due to the COVID-10 pandemic
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Randers Regional Hospital, Aabenraa Hospital
- Study start
- 7 May 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 18 Apr 2018 (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.
Mortality and morbidity remain high after non-cardiac surgery. Known risk factors include age, high ASA grade and emergency surgery. Point-of-care focused cardiac ultrasound may elucidate pathology and potential hemodynamic compromise unknown to handling physicians. This study aims to investigate the effects of focused cardiac ultrasound in high-risk patients undergoing non-cardiac surgery with respect to clinical endpoints.
Detailed description
In non-cardiac surgery major risk factors for morbidity and mortality include ASA classification, age, acute surgery and pre-existing cardiopulmonary disease. These risk factors are sometimes readily available and, along with the type of surgery, allow anaesthesiologists to tailor anaesthetic drugs, fluid therapy and monitoring to the individual patient need. However, cardiopulmonary disease may be occult or masked by other patient-related incapacities. Hence, identification of cardiopulmonary disease is an important priority during the pre-operative anaesthesia evaluation. Routine pre-operative anaesthesia evaluation includes screening with auscultation, blood tests and often electrocardiography. However, these exams are insensitive for detecting cardiopulmonary diseases that may be life threatening during anaesthesia, including ischaemia, heart valve disease and left ventricular hypertrophy.
Point-of-care focused cardiac ultrasound (FOCUS) is claimed to be an effective method for filling out this obvious gap in rapid diagnostic capability, as FOCUS can detect both structural and functional cardiac disease as well as pleural effusion. FOCUS performed by anaesthesiologists can identify unknown pathologies in surgical patients and identification of these enables prediction of perioperative morbidity. Although pre-operative FOCUS has been shown to alter anaesthetic patient management, it remains unclear whether the application of FOCUS actually impacts patient outcome.
This study aims to clarify whether pre-operative FOCUS changes clinical outcomes in high-risk patients undergoing acute, non-cardiac surgery.
The hypothesis of the study is that pre-operative FOCUS reduces the fraction of patients admitted to hospital for more than 10 days or are dead within 30 days after high risk, non-cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Preoperative point-of-care focused cardiopulmonary ultrasound (FOCUS) Patients are to be randomised in a 1:1 ratio to either 1) FOCUS prior to anaesthesia or 2) no FOCUS performed (standard treatment).
| Arm | Type | Receives |
|---|---|---|
| FOCUS (focused cardiac ultrasound) | Active comparator | Diagnostic Test: FOCUS (focused cardiac ultrasound)Patients allocated to FOCUS will receive a preoperative FOCUS examination in conjunction with a standard anesthetic preoperative evaluation. |
| Control | No intervention | –Patients allocated til control arm will receive a standard anesthetic preoperative evaluation according to hospitals' standards. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for emergency (< 6 hours) or urgent surgery (< 24 hours)15
- General or neuro-axial anaesthesia planned at the first anesthetic visit
- ASA classification 3 or 4.
- Age ≥ 65 years
Key exclusion criteria (7 listed)
- Previous surgery performed during current hospital admission (including transfers from other hospitals than Randers Regional Hospital/Hospital of Southern Jutland)
- Low risk surgery or expected surgery time < 30 minutes or endoscopies.
- Lack of consent from patient or proxy (in case of patient mental incapacity)
- Previous participation in the study. Pre-operative FOCUS not possible for logistical reasons or due to requirement for immediate surgery
- Patients who refuse participation after formal inclusion will drop out.
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 |
|---|---|---|
| FOCUS (focused cardiac ultrasound)A ultrasound of the heart and pleura will be performed. This provide information on * Left ventricular systolic function * Left ventricular diastolic function * Right ventricular systolic function * Right ventricular pressure overload * Biventricular sizes * Pathology of the mitral- and aortic valves * Pericardial fluid * Gross fluid status * Pleural effusion | Diagnostic test | FOCUS (focused cardiac ultrasound) |
Primary outcome
Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days
Time frame: 30 days after surgery
35 secondary outcomes
Length of stay
Time frame: Up to 180 days after surgery
Re-admissions to hospital
Time frame: Up to 90 days after surgery
Length of stay
Time frame: Up to 90 days after surgery
Death ≤ 30 days & ≤ 90 days
Time frame: Up to 90 days after surgery
Intensive care treatment
Time frame: Up to 90 days after surgery
Postoperative ventilator treatment
Time frame: Up to 90 days after surgery
Admittance to the post-operative care unit
Time frame: Up to 1 day after surgery
Development of acute kidney injury
Time frame: Within 7 days of surgery
Accumulated intra- and postoperative infusion of norepinephrine, epinephrine, phenylephrine, ephedrine, dobutamine, dopamine and other vasoactive drugs.
Time frame: From start of anaesthesia til end of anaesthesia
Accumulated fluid balance
Time frame: From start of anaesthesia til end of anaesthesia
Echocardiography
Time frame: From anaeshetic visit to start of anaesthesia
Surgery cancellations due to preoperative FOCUS
Time frame: Before start of anaeshesia
Surgery postponements due to preoperative FOCUS
Time frame: Within 7 days of preoperative anaesthetic visit
Surgery changes
Time frame: From FOCUS to the start of surgery
Perioperative myocardial damage
Time frame: From the day before surgery to the day following surgery
Changes in anesthetic practice
Time frame: From start of anaesthesia to start of surgery
Echocardiography
Time frame: From FOCUS to start of surgery
Volume
Time frame: From FOCUS to the start of anaesthesia
Anaesthesia type
Time frame: From FOCUS to the start of anaesthesia
Anaesthetic monitoring
Time frame: From start of anaesthesia to end of anaesthesia
Anesthesia time
Time frame: From start of anaesthesia to end of anaesthesia
Surgery time
Time frame: From start of surgery to end of surgery
Cardiogenic pulmonary oedema
Time frame: From start of anaesthesia to 30 days after surgery
New onset cardiac arrhythmia
Time frame: From start of anaesthesia to 30 days after surgery
Non-fatal cardiac arrest
Time frame: From start of anaesthesia to 30 days after surgery
Anastomotic breakdown
Time frame: From start of anaesthesia to 30 days after surgery
Myocardial infarction
Time frame: From start of anaesthesia to 30 days after surgery
Stroke
Time frame: From start of anaesthesia to 30 days after surgery
Pulmonary embolism
Time frame: From start of anaesthesia to 30 days after surgery
Postoperative haemorrhage
Time frame: From end of anaesthesia to 30 days after surgery
Gastrointestinal bleed
Time frame: From start of anaesthesia to 30 days after surgery
Pneumonia
Time frame: From start of anaesthesia to 30 days after surgery
Surgical site infection
Time frame: From end of anaesthesia to 30 days after surgery
Urinary tract infection
Time frame: From end of anaesthesia to 30 days after surgery
Infektion, source unknown
Time frame: From end of anaesthesia to 30 days after surgery
Results and safety
The study was stopped early (reason given: Impossible patient inclusion due to the COVID-10 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- BackgroundM Saklad. Grading patients for surgical procedures. Anesthesiology 1941;2:281-4
- Background: PubMed 17544078Davenport DL, Ferraris VA, Hosokawa P, Henderson WG, Khuri SF, Mentzer RM Jr. Multivariable predictors of postoperative cardiac adverse events after general and vascular surgery: results from the patient safety in surgery study. J Am Coll Surg. 2007 Jun;204(6):1199-210. doi: 10.1016/j.jamcollsurg.2007.02.065.
- Background: PubMed 19104171Kheterpal S, O'Reilly M, Englesbe MJ, Rosenberg AL, Shanks AM, Zhang L, Rothman ED, Campbell DA, Tremper KK. Preoperative and intraoperative predictors of cardiac adverse events after general, vascular, and urological surgery. Anesthesiology. 2009 Jan;110(1):58-66. doi: 10.1097/ALN.0b013e318190b6dc.
- Background: PubMed 16135919Khuri SF, Henderson WG, DePalma RG, Mosca C, Healey NA, Kumbhani DJ; Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005 Sep;242(3):326-41; discussion 341-3. doi: 10.1097/01.sla.0000179621.33268.83.
- Background: PubMed 16996851Asch FM, Shah S, Rattin C, Swaminathan S, Fuisz A, Lindsay J. Lack of sensitivity of the electrocardiogram for detection of old myocardial infarction: a cardiac magnetic resonance imaging study. Am Heart J. 2006 Oct;152(4):742-8. doi: 10.1016/j.ahj.2006.02.037.
- Background: PubMed 2237552Olive KE, Grassman ED. Mitral valve prolapse: comparison of diagnosis by physical examination and echocardiography. South Med J. 1990 Nov;83(11):1266-9. doi: 10.1097/00007611-199011000-00008.
- Background: PubMed 12882077Beyerbacht HP, Bax JJ, Lamb HJ, van der Laarse A, Vliegen HW, de Roos A, Zwinderman AH, van der Wall EE. Evaluation of ECG criteria for left ventricular hypertrophy before and after aortic valve replacement using magnetic resonance imaging. J Cardiovasc Magn Reson. 2003 Jul;5(3):465-74. doi: 10.1081/jcmr-120022262.
- Background: PubMed 23051882Holm JH, Frederiksen CA, Juhl-Olsen P, Sloth E. Perioperative use of focus assessed transthoracic echocardiography (FATE). Anesth Analg. 2012 Nov;115(5):1029-32. doi: 10.1213/ANE.0b013e31826dd867. Epub 2012 Oct 9. No abstract available.
- Background: PubMed 24865842Botker MT, Vang ML, Grofte T, Sloth E, Frederiksen CA. Routine pre-operative focused ultrasonography by anesthesiologists in patients undergoing urgent surgical procedures. Acta Anaesthesiol Scand. 2014 Aug;58(7):807-14. doi: 10.1111/aas.12343. Epub 2014 May 28.
- Background: PubMed 25220551Kratz T, Campo Dell'Orto M, Exner M, Timmesfeld N, Zoremba M, Wulf H, Steinfeldt T. Focused intraoperative transthoracic echocardiography by anesthesiologists: a feasibility study. Minerva Anestesiol. 2015 May;81(5):490-6. Epub 2014 Sep 15.
- Background: PubMed 22920841Cowie B. Focused transthoracic echocardiography predicts perioperative cardiovascular morbidity. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):989-93. doi: 10.1053/j.jvca.2012.06.031. Epub 2012 Aug 22.
- Background: PubMed 22452367Canty DJ, Royse CF, Kilpatrick D, Williams DL, Royse AG. The impact of pre-operative focused transthoracic echocardiography in emergency non-cardiac surgery patients with known or risk of cardiac disease. Anaesthesia. 2012 Jul;67(7):714-20. doi: 10.1111/j.1365-2044.2012.07118.x. Epub 2012 Mar 27.
- Individual participant dataSharing planned: Yes. Protocol and statistical plan will be published in a peer-reviewed journal. Study results will be made available at a freely accessible online site.
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Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension
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.
Jan Pallesen, MD principal investigator
Randers Regional Hospital
Rajesh Bhavsar, MD principal investigator
Aabenraa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCUS (focused cardiac ultrasound) in people with Cardiopulmonary Disease and Surgery, run by Aarhus 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Apr 2021. 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?
The study was stopped early (reason given: Impossible patient inclusion due to the COVID-10 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501927, which also lists 27 linked publications.
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 30 Apr 2021.