Impact of Spontaneous Breathing on Ventilation Distributi... | NCT01382927

Studies
Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients

NCT01382927

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Jun 27, 2011Estimated

Enrollment

16Estimated

Phase

Not provided

Conditions

Obesity
Hip Arthroplasty
General Anesthesia
Spinal Anesthesia
Atelectasis

Interventions

Not provided

Countries

Germany

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 22, 2011

First Submission Date that Met QC Criteria

Jun 24, 2011

First Posted Date

Jun 27, 2011Estimated

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

Jun 24, 2011

Last Update Posted Date

Jun 27, 2011Estimated

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

General anesthesia (GA) and paralysis are factors which facilitate atelectasis formation, especially in obese patients. Spontaneous breathing can reduce the amount of atelectasis. In this study, the investigators are comaparing obese patients undergoing hip arthroplasty in GA versus spinal anesthesia. Distribution of ventilation during and after anesthesia is assessed by eletrical impedance tomography (EIT).

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

Not provided

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

16Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
arterial pO2 on room air		24hrs
Center of Ventilation	measured by EIT	24hrs

Secondary Outcomes

Measure	Description	Time Frame
Peak Flow		24hrs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI >30
age 18-85
elective hip arthroplasty in general anesthesia or spinal anesthesia

Exclusion Criteria:

pregnancy/breastfeeding
allergies against drugs used for the anesthesia
contraindications for EIT
severe cardiac or pulmonary comorbidities
unable to consent or understand/follow study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Obese Patients aged 18-85, scheduled for elective hip arthroplasty

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Carl-Gustav-Carus	Recruiting	Dresden	Germany	01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
General Anesthesia
Spinal Anesthesia