Peripheral Perfusion Index in Acute Surgical Patients

NCT03757442 | Completed DMC

• 1 other identifier: W217038300-2018-77
• Study Type: observational
• Target: 1,338
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Fracture of Hip; Ileus; Perforated Viscus; Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• Any severe complication or death

  Severe postoperative complications (Clavien Dindo III-IV) or death (Clavien Dindo V)

  30 days

Secondary Outcomes (1)

• Any severe complication or death

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• No sampling of PPI registered
• Foreign/temporary civil registration number that prevents follow up
• Earlier enrollment in cohort

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Department of Anesthesia, Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31753878 DERIVED

MeSH Terms

Conditions

Hip Fractures; Ileus; Anastomotic Leak

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research Fellow

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: November 29, 2018
• Study Start: February 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 29, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)