Fracture of HipNCT03757442
Peripheral Perfusion Index in Acute Surgical Patients
An observational study of Fracture of Hip and Ileus, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Introduction Perioperative haemodynamic instability is associated with postoperative morbidity and mortality. Macrocirculatory parameters, such as the conventionally obtained mean arterial blood pressure and cardiac output, may be uncoupled from the microcirculation during sepsis and severe blood loss and may not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Hip, Ileus, Perforated Viscus
- How many people
- 1,338 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2019to 1 Jan 2020
- 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 > 18 years of age having performed acute abdominal or orthopedic surgery from 1th November 2017 through 31th October 2018 at Hvidovre and Bispebjerg University Hospitals. Study subjects will be obtained from the hospitals electronic medical records via specific procedural- or diagnostic codes representing the acute orthopedic or abdominal surgery in the specified one-year period.
Who may be able to join
- Orthopedic surgery patients with fracture of the hip booked for or having performed procedures with the following procedural codes: KNFB02, KNFJ81, KNFJ51, KNFJ52, KNFJ70 representing arthroplasty, intra-medullar nailing, and screws respectively.
- For abdominal surgery patients we include patients booked for acute laparoscopy for diagnostic purposes (KJAH01) and explorative laparotomy (KJAH00). To identify all patients having performed acute abdominal surgery, we also include surgery related to ileus: KJFK00, KJFK01, KJFK10, KJAP00, KJAP01, KJFK96, KJFK97, any perforation of vicera: KJDA60, KJDA70, KJDA80, and any ischemic condition of the gut: KJFB00, KJFB01, KJFB33, KJFB34, KJFB96, KJFB97.
Who cannot join
- No sampling of PPI registered
- Foreign/temporary civil registration number that prevents follow up
- Earlier enrollment in cohort
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesia, Hvidovre Hospital
Hvidovre, Copenhagen, 2650
About this study
Official title: An Observational Study of the Association Between the Perioperatively Measured Peripheral Perfusion Index, Postoperative Complications and Mortality in Acute Surgical Patients
Introduction Perioperative haemodynamic instability is associated with postoperative morbidity and mortality. Macrocirculatory parameters, such as the conventionally obtained mean arterial blood pressure and cardiac output, may be uncoupled from the microcirculation during sepsis and severe blood loss and may not necessarily be optimal resuscitation parameters. The peripheral perfusion index (PPI) is derived from the pulse oximetry signal and reflects perfusion. Reduced peripheral perfusion is associated with morbidity in critically ill patients and in patients following acute surgery. We hypothesize that patients with low intraoperative PPI demonstrate high frequency of postoperative complications and mortality regardless of blood pressure.
Methods and analysis We plan to conduct a prospective observational cohort study in patients undergoing acute non-cardiac surgery (November 1st, 2017 to October 31st, 2018) at two University Hospitals. Data will be collected prospectively from patient records including patient demographics, comorbidity and intraoperative hemodynamic values, with PPI as the primary exposure variable, and postoperative complications and mortality within 30 and 90 days as outcome variables. We primarily assess association between PPI and outcome in multivariate regression models. Secondly, the predictive value of PPI for outcome, using area under the receiver operating characteristics curve is assessed.
Ethics and dissemination Data will be reported according to The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Results will be published in a peer reviewed journal. The study is approved by the regional research ethics committee, storage and management of data has been approved by the Regional Data Protection Agency, and access to medical records is approved by the hospital board of directors at the involved hospitals and departments.
Read the detailed description
Background Perioperative haemodynamic instability is associated with postoperative morbidity and mortality. Patients undergoing acute major abdominal or hip fracture surgery have high complication rates and account for a major part of overall postoperative mortality in developed countries. These patients are often frail, with multiple comorbidities making them vulnerable to anaesthesia and surgery. Despite the benefit of a multidisciplinary effort to improve perioperative care, such patients demonstrate a high risk of complications and death. Conventional perioperative haemodynamic monitoring is often based only on heart rate (HR) and mean blood pressure (MAP). Although perioperative hypotension is associated with complications in major surgery, blood pressure is often an inadequate marker of perioperative organ perfusion, consequently leading to little precision in administration of fluid and vasoactive medication. Minimally-invasive haemodynamic monitoring of cardiac output (CO), and goal directed therapy based on stroke volume optimization, has been associated with improved outcome in major elective surgery, but high quality evidence for the advantage of such monitoring in emergency surgery is sparse.
Macrocirculatory parameters such as MAP and CO may be uncoupled from the microcirculation during sepsis and severe blood loss due to sympathetic or medically induced vasoconstriction, and as such, these parameters are not necessarily optimal for resuscitation.
Assuming that blood flow is directed from peripheral tissue to vital organs during progressive stages of circulatory impairment and shock, a non-invasive method to detect impaired peripheral perfusion could be a relevant endpoint.
The peripheral perfusion index (PPI) has the advantage that is derived from the photoelectric plethysmographic pulse oximetry signal most likely obtained in all patients for evaluation of arterial oxygen saturation (SAT) already in the emergency room and continued during and after surgery as in wards and in the ICU. The PPI reflects the ratio between the pulsatile and non-pulsatile component of the arterial waveform as assessed by light traversing the tissue addressed, most often the finger, and it decreases in response to hypoperfusion.Thus, PPI reflects changes in peripheral perfusion and blood volume and reduced peripheral perfusion is associated with morbidity following acute surgery, in critically ill patients, and patients presenting septic shock. However, it remains uncertain which threshold for PPI should trigger intervention in patients undergoing acute surgery reflecting that evaluation is made only in relatively small populations of mixed medical and surgical patients.
Hypothesis We hypothesize that PPI reflects impaired peripheral circulation and that patients with low intraoperative PPI, independent of MAP, have higher risk of postoperative complications and mortality than patients with normal or high PPI.
Objectives The main objective of this study is to evaluate the association between intraoperative PPI and outcome defined as severe postoperative complications and 30- and 90-days mortality. Secondly, we assess the predictive value of intraoperative PPI in relation to outcome and evaluate whether PPI has better prediction of adverse outcome than the commonly used MAP thresholds and try to establish intervention thresholds for PPI that in acute non-cardiac surgical patients.
- Conditions
- Fracture of Hip, Ileus, Perforated Viscus, Anastomotic Leak
- Medical subject headings
- Hip Fractures, Ileus, Anastomotic Leak
What is being measured
The primary outcome is the main question the study is designed to answer.
Any severe complication or death
Severe postoperative complications (Clavien Dindo III-IV) or death (Clavien Dindo V)
Measured: 30 days
Secondary outcomes (1)
Any severe complication or death
Severe postoperative complications (Clavien Dindo III-IV) or death (Clavien Dindo V)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Feb 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture of HipStudies 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
- Retrospective
- Enrolment
- 1,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Agerskov, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757442
- Sponsor's protocol ID
- W217038300-2018-77
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agerskov M, Thusholdt ANW, Hojlund J, Meyhoff CS, Sorensen H, Wiberg S, Secher NH, Bang Foss N. Protocol for a multicentre retrospective observational cohort study in Denmark: association between the intraoperative peripheral perfusion index and postoperative morbidity and mortality in acute non-cardiac surgical patients. BMJ Open. 2019 Nov 21;9(11):e031249. doi: 10.1136/bmjopen-2019-031249.
PubMed 31753878
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Association Between the Perioperatively Measured Peripheral Perfusion Index, Postoperative Complications and Mortality in Acute Surgical Patients
- ClinicalTrials.gov ID
- NCT03757442
- Acronym / sponsor ID
- W217038300-2018-77
- Conditions
- Fracture of Hip, Ileus, Perforated Viscus, Anastomotic Leak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,338 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 29 Nov 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.
Introduction Perioperative haemodynamic instability is associated with postoperative morbidity and mortality. Macrocirculatory parameters, such as the conventionally obtained mean arterial blood pressure and cardiac output, may be uncoupled from the microcirculation during sepsis and severe blood loss and may not necessarily be optimal resuscitation parameters. The peripheral perfusion index (PPI) is derived from the pulse oximetry signal and reflects perfusion. Reduced peripheral perfusion is associated with morbidity in critically ill patients and in patients following acute surgery. We hypothesize that patients with low intraoperative PPI demonstrate high frequency of postoperative complications and mortality regardless of blood pressure.
Methods and analysis We plan to conduct a prospective observational cohort study in patients undergoing acute non-cardiac surgery (November 1st, 2017 to October 31st, 2018) at two University Hospitals. Data will be collected prospectively from patient records including patient demographics, comorbidity and intraoperative hemodynamic values, with PPI as the primary exposure variable, and postoperative complications and mortality within 30 and 90 days as outcome variables. We primarily assess association between PPI and outcome in multivariate regression models. Secondly, the predictive value of PPI for outcome, using area under the receiver operating characteristics curve is assessed.
Ethics and dissemination Data will be reported according to The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Results will be published in a peer reviewed journal. The study is approved by the regional research ethics committee, storage and management of data has been approved by the Regional Data Protection Agency, and access to medical records is approved by the hospital board of directors at the involved hospitals and departments.
Detailed description
Background Perioperative haemodynamic instability is associated with postoperative morbidity and mortality. Patients undergoing acute major abdominal or hip fracture surgery have high complication rates and account for a major part of overall postoperative mortality in developed countries. These patients are often frail, with multiple comorbidities making them vulnerable to anaesthesia and surgery. Despite the benefit of a multidisciplinary effort to improve perioperative care, such patients demonstrate a high risk of complications and death. Conventional perioperative haemodynamic monitoring is often based only on heart rate (HR) and mean blood pressure (MAP). Although perioperative hypotension is associated with complications in major surgery, blood pressure is often an inadequate marker of perioperative organ perfusion, consequently leading to little precision in administration of fluid and vasoactive medication. Minimally-invasive haemodynamic monitoring of cardiac output (CO), and goal directed therapy based on stroke volume optimization, has been associated with improved outcome in major elective surgery, but high quality evidence for the advantage of such monitoring in emergency surgery is sparse.
Macrocirculatory parameters such as MAP and CO may be uncoupled from the microcirculation during sepsis and severe blood loss due to sympathetic or medically induced vasoconstriction, and as such, these parameters are not necessarily optimal for resuscitation.
Assuming that blood flow is directed from peripheral tissue to vital organs during progressive stages of circulatory impairment and shock, a non-invasive method to detect impaired peripheral perfusion could be a relevant endpoint.
The peripheral perfusion index (PPI) has the advantage that is derived from the photoelectric plethysmographic pulse oximetry signal most likely obtained in all patients for evaluation of arterial oxygen saturation (SAT) already in the emergency room and continued during and after surgery as in wards and in the ICU. The PPI reflects the ratio between the pulsatile and non-pulsatile component of the arterial waveform as assessed by light traversing the tissue addressed, most often the finger, and it decreases in response to hypoperfusion.Thus, PPI reflects changes in peripheral perfusion and blood volume and reduced peripheral perfusion is associated with morbidity following acute surgery, in critically ill patients, and patients presenting septic shock. However, it remains uncertain which threshold for PPI should trigger intervention in patients undergoing acute surgery reflecting that evaluation is made only in relatively small populations of mixed medical and surgical patients.
Hypothesis We hypothesize that PPI reflects impaired peripheral circulation and that patients with low intraoperative PPI, independent of MAP, have higher risk of postoperative complications and mortality than patients with normal or high PPI.
Objectives The main objective of this study is to evaluate the association between intraoperative PPI and outcome defined as severe postoperative complications and 30- and 90-days mortality. Secondly, we assess the predictive value of intraoperative PPI in relation to outcome and evaluate whether PPI has better prediction of adverse outcome than the commonly used MAP thresholds and try to establish intervention thresholds for PPI that in acute non-cardiac surgical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients > 18 years of age having performed acute abdominal or orthopedic surgery from 1th November 2017 through 31th October 2018 at Hvidovre and Bispebjerg University Hospitals. Study subjects will be obtained from the hospitals electronic medical records via specific procedural- or diagnostic codes representing the acute orthopedic or abdominal surgery in the specified one-year period.
Key inclusion criteria (2 listed)
- Orthopedic surgery patients with fracture of the hip booked for or having performed procedures with the following procedural codes: KNFB02, KNFJ81, KNFJ51, KNFJ52, KNFJ70 representing arthroplasty, intra-medullar nailing, and screws respectively.
- For abdominal surgery patients we include patients booked for acute laparoscopy for diagnostic purposes (KJAH01) and explorative laparotomy (KJAH00). To identify all patients having performed acute abdominal surgery, we also include surgery related to ileus: KJFK00, KJFK01, KJFK10, KJAP00, KJAP01, KJFK96, KJFK97, any perforation of vicera: KJDA60, KJDA70, KJDA80, and any ischemic condition of the gut: KJFB00, KJFB01, KJFB33, KJFB34, KJFB96, KJFB97.
Key exclusion criteria (3 listed)
- No sampling of PPI registered
- Foreign/temporary civil registration number that prevents follow up
- Earlier enrollment in cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Any severe complication or death
Time frame: 30 days
Severe postoperative complications (Clavien Dindo III-IV) or death (Clavien Dindo V)
1 secondary outcome
Any severe complication or death
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 31753878Agerskov M, Thusholdt ANW, Hojlund J, Meyhoff CS, Sorensen H, Wiberg S, Secher NH, Bang Foss N. Protocol for a multicentre retrospective observational cohort study in Denmark: association between the intraoperative peripheral perfusion index and postoperative morbidity and mortality in acute non-cardiac surgical patients. BMJ Open. 2019 Nov 21;9(11):e031249. doi: 10.1136/bmjopen-2019-031249.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fracture of Hip and Ileus, run by Hvidovre 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jan 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Any severe complication or death (time frame: 30 days). 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 NCT03757442, which also lists 1 linked publication.
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 29 Jan 2021.