Myocardial Injury and Intraoperative Tissue Oximetry in Patients Undergoing Spine Surgery

NCT03518372 | Completed

• 2 other identifiers: Tissue Oximetry and TroponinIRB#14-12996
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Myocardial injury after non-cardiac surgery (MINS) is common in patients undergoing major surgery. Many of the events are undetected and associated with a high 30-day mortality risk. Knowledge of which perioperative factors that predicts MINS is lacking. Decrease in tissue oxygenation (StO2) is common in patients undergoing major spine surgery and is associated with postoperative complications in these patients. However, an association between decrease in tissue oxygenation and MINS has not been examined. This group of patients may have other potential predictors of postoperative complications that the study group would like to investigate. In this observational cohort study, we will include 70 patients undergoing major spine surgery at University of California San Francisco. The primary hypothesis is that decrease in intraoperative tissue oxygenation is associated with postoperative myocardial injury.

Conditions

Hypoxia; Myocardial Injury; Surgery--Complications

Keywords

Hypoxia; Myocardial Injury; Surgery--Complications; Tissue Oximetry; Near-infrared Spectroscopy (NIRS)

Outcome Measures

Primary Outcomes (1)

• High-sensitivity Troponin T elevation

  Peak value (the highest of two postoperative measurements) of high-sensitivity Troponin T (hsTnT) elevation (as assessment for myocardial injury).

  Measurement done on first and second day after surgery (highest value of the two is used in the primary analysis)

Secondary Outcomes (1)

• Myocardial injury after non-cardiac surgery (MINS)

  Baseline prior to surgery (for adjustment), first and second day after surgery.

Other Outcomes (5)

• Myocardial infarction

  Within 30 days after surgery

• Non-fatal cardiac arrest

  Within 30 days after surgery

• Transient cerebral ischemia (TCI)

  Within 30 days after surgery

Eligibility Criteria

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

Study Population

Eligible patients are undergoing spine surgery at University of California, San Francisco at the Parnassus Campus.

You may qualify if:

• Male or female ≥18 years
• Patient is undergoing elective surgery of the spine
• Surgery is scheduled to last ≥ 2 hours and involve instrumentation

You may not qualify if:

• Patient is \< 18 years
• Patient is undergoing emergent or urgent surgery
• American Society of Anesthesiologist (ASA) status \> IV
• Patient is undergoing non-instrumental surgery, such as laminectomy alone
• Patient is undergoing spine surgery for tumor or infection

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Meng L, Xiao J, Gudelunas K, Yu Z, Zhong Z, Hu X. Association of intraoperative cerebral and muscular tissue oxygen saturation with postoperative complications and length of hospital stay after major spine surgery: an observational study. Br J Anaesth. 2017 Apr 1;118(4):551-562. doi: 10.1093/bja/aex008.

  PMID: 28403400 BACKGROUND

• Bernholm KF, Meyhoff CS, Bickler P. Association between tissue oxygenation and myocardial injury in patients undergoing major spine surgery: a prospective cohort study. BMJ Open. 2021 Sep 17;11(9):e044342. doi: 10.1136/bmjopen-2020-044342.

  PMID: 34535471 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples: Plasma for high-sensitivity Troponin T analysis. Three samples in total: One baseline, one on first postoperative day and one on second postoperative day. Each samples is 4.5 mL.

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Phil Bickler, MD PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 8, 2018
• Study Start: January 2, 2018
• Primary Completion: July 24, 2018
• Study Completion: July 24, 2018
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)