Peripheral PerfusionNCT03395483
Peripheral and Mesenteric Perfusion in Elective Surgical Patients
An observational study of Peripheral Perfusion and Bowel Ischemia, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
An important goal of haemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. The mesenteric haemodynamic response to circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Peripheral Perfusion, Bowel Ischemia, Colorectal Surgery
- What is being tested?
- Haemodynamic monitoring
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Apr 2018to 1 Oct 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: x
Who may be able to join
- Adult
- Elective colorectal surgery, low anterior resection of the colon, sigmoid colectomy or right hemicolectomy
- Written informed consent
Who cannot join
- No consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Peripheral Perfusion Index; Correlations Between Peripheral and Mesenteric Perfusion in Elective Surgical Patients
An important goal of haemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. The mesenteric haemodynamic response to circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty. Assuming blood flow is diverted from the peripheral tissue and the gastrointestinal tract to vital organs, during circulatory shock, an objective, simple and non-invasive method of detecting peripheral tissue perfusion impairment might detect this at an early stage.
The peripheral perfusion index (PPI) reflects changes in peripheral perfusion and laser doppler flowmetry allows measurement of bowel tissue perfusion.
The aim of this study is to explore the association between changes in peripheral and intestinal perfusion in patients undergoing elective colorectal surgery exposed to intraoperative haemodynamic challenges.
Read the detailed description
An important goal of haemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation, but in clinical practice, monitoring and resuscitation is routinely based on measuring of blood pressure and heart rate, which might be inadequate endpoints for optimal resuscitation. Haemodynamic management targeting cardiac output and stroke volume (SV), and to some extent, flow and tissue perfusion is feasible when applying minimally-invasive or non-invasive methods, but has been limited to a narrow number of critically ill patients and to the intraoperative setting. Another approach to resuscitation is aimed at flow and perfusion of vital organs. Ideally, measurements would be done directly on these organs, but no feasible methods exist. Assuming blood flow is diverted from the peripheral tissue and the gastrointestinal tract to vital organs, during circulatory shock, an objective, simple and non-invasive method of detecting peripheral tissue perfusion impairment might detect this at an early stage. The peripheral perfusion index (PPI) is derived from the photoelectric plethysmographic pulse oximetry signal, which all patients are monitored by perioperatively to assess arterial oxygen saturation. The PPI is a numerical non-invasive measure representing the ratio between the pulsatile (arterial) and non-pulsatile component of the light reaching the pulse oximeter, and PPI decreases in states of hypoperfusion. PPI reflects changes in peripheral perfusion and blood volume and decreased peripheral perfusion determined by PPI predicts surgical complications and morbidity in acute surgical and septic shock patients.
The mesenteric haemodynamic response to circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty for the clinicians due to its non specific presentations and lack of a simple diagnostic test. In patients undergoing colorectal surgery for malignancy, laser doppler flowmetry allows measurement of bowel tissue perfusion.
The aim of this study is to explore the association between changes in peripheral and intestinal perfusion in patients undergoing elective colorectal surgery exposed to intraoperative haemodynamic challenges.
- Being tested
- Haemodynamic monitoring
- Keywords
- peripheral perfusion, Haemodynamic Instability, mesenteric bloodflow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemodynamic monitoringOther
see Group description
| Study group | Role | What they receive |
|---|---|---|
| Elective, adult colorectal surgical patients | All patients will be monitored by the non-invasive Masimo Radical7 pulseoximeter (Masimo, Irvine, CA, USA) measuring PPI and the MoorVMS-LDF (Moor Instruments Ldt., Axminster, UK) measuring mesenteric tissue blood flow using doppler flowmetry. Patients will be subjected to a haemodynamic challenge using anti-trendelenburg position. Receives: Other: Haemodynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral perfusion index and mesenteric perfusion changes from baseline after haemodynamic challenges
Association between PPI and mesenteric perfusion
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start10 Apr 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral PerfusionStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Højlund, Hvidovre University Hospital
- Investigators
- Marianne Agerskov, MD, Research Fellow, Study chair, Department af Anaesthesia, Hvidovre Hospital, University of CopenhagenJakob Højlund, Chief Physician, Principal investigator, Department of Anaesthesia, Hvidovre Hospital, University of CopenhagenNicolai Bang Foss, Clinical Professor, DMSc., Study director, Department of Anaesthesia, Hvidovre Hospital, University of CopenhagenHenrik Sørensen, MD, DMSc., Study chair, Department of Anaesthesiology, Abdominal Centre, Rigshospitalet, University of CopenhagenNiels Secher, Professor, DMSc., Study chair, Department of Anaesthesiology, Abdominal Centre, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395483
- Sponsor's protocol ID
- H-17004663
- Status last verified
- Oct 2019
- First submitted
- 16 Dec 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Peripheral Perfusion Index; Correlations Between Peripheral and Mesenteric Perfusion in Elective Surgical Patients
- ClinicalTrials.gov ID
- NCT03395483
- Acronym / sponsor ID
- H-17004663
- Keywords
- peripheral perfusion, Haemodynamic Instability, mesenteric bloodflow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 10 Jan 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.
An important goal of haemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. The mesenteric haemodynamic response to circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty. Assuming blood flow is diverted from the peripheral tissue and the gastrointestinal tract to vital organs, during circulatory shock, an objective, simple and non-invasive method of detecting peripheral tissue perfusion impairment might detect this at an early stage.
The peripheral perfusion index (PPI) reflects changes in peripheral perfusion and laser doppler flowmetry allows measurement of bowel tissue perfusion.
The aim of this study is to explore the association between changes in peripheral and intestinal perfusion in patients undergoing elective colorectal surgery exposed to intraoperative haemodynamic challenges.
Detailed description
An important goal of haemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation, but in clinical practice, monitoring and resuscitation is routinely based on measuring of blood pressure and heart rate, which might be inadequate endpoints for optimal resuscitation. Haemodynamic management targeting cardiac output and stroke volume (SV), and to some extent, flow and tissue perfusion is feasible when applying minimally-invasive or non-invasive methods, but has been limited to a narrow number of critically ill patients and to the intraoperative setting. Another approach to resuscitation is aimed at flow and perfusion of vital organs. Ideally, measurements would be done directly on these organs, but no feasible methods exist. Assuming blood flow is diverted from the peripheral tissue and the gastrointestinal tract to vital organs, during circulatory shock, an objective, simple and non-invasive method of detecting peripheral tissue perfusion impairment might detect this at an early stage. The peripheral perfusion index (PPI) is derived from the photoelectric plethysmographic pulse oximetry signal, which all patients are monitored by perioperatively to assess arterial oxygen saturation. The PPI is a numerical non-invasive measure representing the ratio between the pulsatile (arterial) and non-pulsatile component of the light reaching the pulse oximeter, and PPI decreases in states of hypoperfusion. PPI reflects changes in peripheral perfusion and blood volume and decreased peripheral perfusion determined by PPI predicts surgical complications and morbidity in acute surgical and septic shock patients.
The mesenteric haemodynamic response to circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty for the clinicians due to its non specific presentations and lack of a simple diagnostic test. In patients undergoing colorectal surgery for malignancy, laser doppler flowmetry allows measurement of bowel tissue perfusion.
The aim of this study is to explore the association between changes in peripheral and intestinal perfusion in patients undergoing elective colorectal surgery exposed to intraoperative haemodynamic challenges.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective, adult colorectal surgical patients | – | Other: Haemodynamic monitoringAll patients will be monitored by the non-invasive Masimo Radical7 pulseoximeter (Masimo, Irvine, CA, USA) measuring PPI and the MoorVMS-LDF (Moor Instruments Ldt., Axminster, UK) measuring mesenteric tissue blood flow using doppler flowmetry. Patients will be subjected to a haemodynamic challenge using anti-trendelenburg position. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- x
Key inclusion criteria (3 listed)
- Adult
- Elective colorectal surgery, low anterior resection of the colon, sigmoid colectomy or right hemicolectomy
- Written informed consent
Key exclusion criteria (1 listed)
- No consent
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 |
|---|---|---|
| Haemodynamic monitoringsee Group description | Other | Elective, adult colorectal surgical patients |
Primary outcome
Peripheral perfusion index and mesenteric perfusion changes from baseline after haemodynamic challenges
Time frame: Perioperatively
Association between PPI and mesenteric perfusion
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 1 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Peripheral Perfusion
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Sepsis
RecruitingObservational study
Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
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Not yet recruitingObservational study
Core-to-Big-Toe Temperature Gradient as a Marker of Peripheral Perfusion in Adult Patients With Septic Shock
Septic Shock, Sepsis
Not yet recruitingPhase 4
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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.
Marianne Agerskov, MD, Research Fellow study chair
Department af Anaesthesia, Hvidovre Hospital, University of Copenhagen
Jakob Højlund, Chief Physician principal investigator
Department of Anaesthesia, Hvidovre Hospital, University of Copenhagen
Nicolai Bang Foss, Clinical Professor, DMSc. study director
Department of Anaesthesia, Hvidovre Hospital, University of Copenhagen
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 Peripheral Perfusion and Bowel Ischemia, 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 3 inclusion and 1 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 1 Nov 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?
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?
Peripheral perfusion index and mesenteric perfusion changes from baseline after haemodynamic challenges (time frame: Perioperatively). 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 1 Nov 2019.