NCT03751605

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 respiratory quotient (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. Unipulmonary ventilation is the rule in thoracic surgery: it improves surgical exposure and protects the operated lung. However, no study has examined the impact of these mechanisms on the indirect measurement of RQ in unipulmonary ventilation. The main objective of our work is to validate indirect RQ measurement during unipulmonary ventilation. The secondary objective was to assess the predictability of postoperative complications of indirect QR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

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

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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
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

November 8, 2018

Last Update Submit

February 28, 2023

Conditions

Keywords

unipulmonary ventilation, complications, respiratory quotient.

Outcome Measures

Primary Outcomes (1)

  • Indirect respiratory quotient

    during surgery

Secondary Outcomes (1)

  • occurrence 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 unipulmonary ventilation in routine thoracic 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 thoracic surgery requiring unipulmonary ventilation Exclusion Criteria: * Cardiac surgery * Laparoscopy * Preoperative oxygen therapy

You may qualify if:

  • Age\>18 years old
  • Adults admitted to the operating room for thoracic surgery requiring unipulmonary ventilation

You may not qualify if:

  • Cardiac surgery
  • Laparoscopy
  • Preoperative oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

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

February 1, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations