Evaluation of Synchrony in the Post-operative Patient | NCT01771341

Studies
Evaluation of Synchrony in the Post-operative Patient

NCT01771341

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Jan 22, 2015Estimated

Enrollment

29Actual

Phase

Not Applicable

Conditions

Patient-ventilator Asynchronism

Interventions

MAQUET SERVOi ventilator with Edi Catheter
MAQUET SERVOi ventilator

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

Jan 2015

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

Feb 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jun 15, 2012

First Submission Date that Met QC Criteria

Jan 16, 2013

First Posted Date

Jan 18, 2013Estimated

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

Jan 21, 2015

Last Update Posted Date

Jan 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pressure support	Placebo Comparator		Device: MAQUET SERVOi ventilator
NAVA	Experimental		Device: MAQUET SERVOi ventilator with Edi Catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MAQUET SERVOi ventilator with Edi Catheter	Device	NAVA respiratory modality	NAVA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Asynchrony index (AI)	Number of asynchrony events/total respiratory rate	8 hours

Secondary Outcomes

Measure	Description	Time Frame
PaO2/FiO2 ratio	ratio of partial pressure arterial oxygen and fraction of inspired oxygen	8 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult > 18 yr-old
abdominal post-operative patient
able to trigger the ventilator

Exclusion Criteria:

infant
pregnancy
esophageal surgery
recent esophageal variceal bleeding

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florent WALLET, MD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud		Pierre-Bénite		69310	France

Intervention Browse Module

MeSH Terms

ID	Term
D059725	Interactive Ventilatory Support

Ancestor Terms

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy

Browse Leaves

Not provided

Browse Branches

Not provided