Indirect Measurement of Respiratory Quotient in Unipulmon... | NCT03751605

Studies
Indirect Measurement of Respiratory Quotient in Unipulmonary Ventilation.

NCT03751605

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Completed

Last Update Posted

Mar 1, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Respiratory Quotient Measurement

Interventions

unipulmonary ventilation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

Feb 1, 2023Actual

First Submitted Date

Nov 8, 2018

First Submission Date that Met QC Criteria

Nov 21, 2018

First Posted Date

Nov 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2023

Last Update Posted Date

Mar 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
unipulmonary ventilation	Procedure	observational study based on the computation of respiratory quotient in patient cohort treated by unipulmonary ventilation in routine thoracic surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Indirect respiratory quotient		during surgery

Secondary Outcomes

Measure	Description	Time Frame
occurrence of at least one post-operative complication	the aim is to predict the occurrence of at least one complication with the use of indirect respiratory quotient	through study completion, an average of 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample