Influence of Inspiratory Flow Pattern on Exchange of Carb... | NCT01686984

Studies
Influence of Inspiratory Flow Pattern on Exchange of Carbon Dioxide in Humans Without Primary Lung Disease

NCT01686984

Sponsor

Region Skane

Status

Completed

Last Update Posted

May 14, 2015Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Pulmonary Gas Exchange
Carbon Dioxide

Interventions

Altered breath

Countries

Sweden

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

May 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

Sep 2012

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Sep 13, 2012

First Submission Date that Met QC Criteria

Sep 17, 2012

First Posted Date

Sep 18, 2012Estimated

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

May 13, 2015

Last Update Posted Date

May 14, 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

The purpose of this study is to investigate how inspiratory flow pattern influences CO2 elimination in people without primary lung disease.

The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause and high end-inspiratory flow, will promote CO2 exchange in the alveoli.

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

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Altered breath	Experimental	The group where the investigators alter the inspiratory and expiratory aspects of a ventilated breath.	Other: Altered breath

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Altered breath	Other		Altered breath

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Carbon dioxide elimination in a ventilator assisted breath.		30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Blood CO2 concentration.		30 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No known primary lung disease

Exclusion Criteria:

Primary lung disease

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
Mikael Bodelsson, Professor	Division of Anesthesia, Skane University Hospital, Lund, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Brain, Heart and Lungs, Neurosurgical Clinic, Skane University Hospital, Lund		Lund	Skåne County	22185	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27440637	Derived	Sturesson LW, Malmkvist G, Allvin S, Collryd M, Bodelsson M, Jonson B. An appropriate inspiratory flow pattern can enhance CO2 exchange, facilitating protective ventilation of healthy lungs. Br J Anaesth. 2016 Aug;117(2):243-9. doi: 10.1093/bja/aew194.