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Indirect Measurement of Respiratory Quotient in Coelioscopic Surgery

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ClinicalTrials.gov Identifier: NCT03751579
Recruitment Status : Unknown
Verified November 2018 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Not yet recruiting
First Posted : November 23, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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


Condition or disease Intervention/treatment
Respiratory Quotient Measurement Procedure: coelioscopic surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Respiratory Quotient Measurement Measured Indirectly in Coelioscopic Surgery
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019
Groups and Cohorts
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Intervention Details:
  • Procedure: coelioscopic surgery
    observational study based on the computation of respiratory quotient in patient cohort treated by routine coelioscopic surgery

Outcome Measures
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Primary Outcome Measures :
  1. Indirect respiratory quotient by measurement of VO2 and VCO2 [ Time Frame: during coelioscopic surgery ]
    The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2)


Secondary Outcome Measures :
  1. occurence of at least one post-operative complication [ Time Frame: through study completion, an average of 6 months ]
    the aim is to predict the occurence of at least one complication with the use of indirect respiratory quotient


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cardiac and thoracic surgery
  • Preoperative oxygen therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751579


Contacts
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Contact: Stéphane Bar Bar.Stephane@chu-amiens.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03751579    
Other Study ID Numbers: PI2018_843_0046
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
coelioscopic
surgery complications
respiratory quotient