NCT03471962

Brief Summary

Demonstrate the ability of the RQ, measured indirectly from the anesthesia ventilator, to predict the occurrence of anaerobic metabolism in patients operated of major non-cardiac surgical operation in the operating room

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

September 18, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

March 14, 2018

Last Update Submit

September 17, 2018

Conditions

Keywords

respiratory quotient (RQ)anaerobic metabolismmajor surgery

Outcome Measures

Primary Outcomes (1)

  • Respiratory Quotient (RQ)

    indirectly measured from the anesthetic respirator, and its predictive ability to develop anaerobic metabolism.

    1 Month

Interventions

surgeryOTHER

Indirect measurement of RQ was performed by anesthesia ventilator and compared to marker of anaerobic metabolism (arterial lactate, venoarterial PCO2 gradient, venoarterial PCO2 gradient/ arteriovenous O2 content difference, ScVO2) at different time of the srugery (every hours). In post-operative time, complications and hospital's length of stay were recorded.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to the operating room of Amiens University Hospital supported for major non-cardiac surgery (abdominal, orthopedic, vascular) for which the practitioner had decided in accordance with the care protocols of the department to carry out an hemodynamic optimization

You may qualify if:

  • Adult patients admitted to the operating room of Amiens University Hospital supported for major non-cardiac surgery (abdominal, orthopedic, vascular) for which the practitioner had decided in accordance with the care protocols of the department to carry out an hemodynamic optimization,
  • Patients monitored by a central venous catheter and an invasive measurement of blood pressure,
  • Ventilated patients in controlled mode,
  • Major patients.

You may not qualify if:

  • Cardiac surgery with the need of extracorporeal circulation
  • Thoracic surgery with the need of unipulmonary ventilation
  • Permanent laparoscopic surgery and up to 30 minutes after exsufflation of CO2
  • Acute or chronic respiratory insufficiency documented
  • Interstitial lung disease with diffusion disorders
  • Preoperative oxygen therapy
  • Acute Respiratory Distress Syndrome with FiO2\> 60%.
  • Refusal of patient participation.
  • Pregnant woman.
  • Patient under guardianship or curatorship or deprived of public right.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

Related Publications (1)

  • Bar S, Grenez C, Nguyen M, de Broca B, Bernard E, Abou-Arab O, Bouhemad B, Lorne E, Guinot PG. Predicting postoperative complications with the respiratory exchange ratio after high-risk noncardiac surgery: A prospective cohort study. Eur J Anaesthesiol. 2020 Nov;37(11):1050-1057. doi: 10.1097/EJA.0000000000001111.

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Stéphane BAR, Dr

    CHU AMIENS-PICARDIE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 21, 2018

Study Start

May 4, 2017

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

September 18, 2018

Record last verified: 2018-08

Locations