NCT03751579

Brief Summary

The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis. A study has been conducted in our department to demonstrate the ability of the indirectly measured RQ from the inspired and exhaled breath analysis of the anesthetic respirator to predict the onset of anaerobic metabolism and postoperative complications in the operating room. But, because of artificially increase of carbon dioxide due to insufflation, coelioscopic surgery was an exclusion criteria of our pilot study. However, no study has examined the impact of coelioscopy on the indirect measurement of RQ

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

November 8, 2018

Last Update Submit

May 9, 2023

Conditions

Keywords

coelioscopicsurgery complicationsrespiratory quotient

Outcome Measures

Primary Outcomes (1)

  • Indirect respiratory quotient by measurement of VO2 and VCO2

    The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2)

    during coelioscopic surgery

Secondary Outcomes (1)

  • occurence of at least one post-operative complication

    through study completion, an average of 6 months

Interventions

observational study based on the computation of respiratory quotient in patient cohort treated by routine coelioscopic surgery

Eligibility Criteria

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

Inclusion Criteria: * Age\>18 years old * Adults admitted to the operating room for coelioscopic surgery Exclusion Criteria: * Cardiac and thoracic surgery * Preoperative oxygen therapy

You may qualify if:

  • Age\>18 years old
  • Adults admitted to the operating room for coelioscopic surgery

You may not qualify if:

  • Cardiac and thoracic surgery
  • Preoperative oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bar S, Santarelli D, de Broca B, Abou Arab O, Leviel F, Miclo M, Dupont H, Guinot PG, Lorne E. Predictive value of the respiratory exchange ratio for the occurrence of postoperative complications in laparoscopic surgery: a prospective and observational study. J Clin Monit Comput. 2021 Aug;35(4):849-858. doi: 10.1007/s10877-020-00544-5. Epub 2020 Jun 12.

0

Study Design

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

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 23, 2018

Study Start

November 1, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 10, 2023

Record last verified: 2023-05