Lung Ventilation During Cardiopulmonary Resuscitation | NCT02420483

Studies
Lung Ventilation During Cardiopulmonary Resuscitation

NCT02420483

Sponsor

University of Thessaly

Status

Unknown status

Last Update Posted

May 3, 2017Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Ventilation During Cardiopulmonary Resuscitation

Interventions

Cardiopulmonary resuscitation chest compressions

Countries

Greece

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 2017

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

Dec 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Mar 27, 2015

First Submission Date that Met QC Criteria

Apr 14, 2015

First Posted Date

Apr 17, 2015Estimated

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 2, 2017

Last Update Posted Date

May 3, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

DEMOSTHENES MAKRIS, ASS PROFESSOR CRITICAL CARE MEDICINE, University of ThessalyPrincipal Investigator

Lead Sponsor

University of ThessalyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 authors to measure passive tidal volumes generated during external chest compressions in order to determine whether chest compressions alone without any mechanical ventilatory support in cardiopulmonary resuscitation can provide adequate ventilation. The authors will study 25 volunteers who meet the following inclusion criteria: age 18-55 years, ASA I-II, candidates for surgical operation, who will receive general anesthesia. Patients who will be operated in the chest, who present musculoskeletal diseases, cardiopulmonary or vascular acute or chronic diseases, who had history of pneumothorax, of thromboembolism, osteoporosis, menopause, history of current rib or sternal or clavicle fractures, will be excluded. All eligible patients will enter the study and will receive general anesthesia and intubation according to treating doctors' decision.

Patients will be ventilated mechanically for 5 minutes to establish stable conditions. A pneumotachograph will be then connected to the ventilatory circuit so that respiratory efforts (volume, airway pressure and flow) can be continuously monitored at real time.

An esophageal catheter will be then inserted to monitor esophageal pressures and to provide data for lung mechanics calculation. Following the above procedures and before any surgical procedure, chest compressions will be performed to the patient by a senior anesthesiologist according to ERC guidelines of 2010 for 30 seconds.

Following chest compressions, patients will be evaluated for possible complications and after the establishment of stable conditions surgical procedures will follow. After the end of the surgical operation clinical and chest ultrasound evaluation will be performed.

Written inform consent will be obtained by all patients before procedures.

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

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients	Experimental	Cardiopulmonary resuscitation with measurement of tidal volume, airway pressure and flow by a pneumotachograph and airway, oesophageal pressure sensors	Other: Cardiopulmonary resuscitation chest compressions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiopulmonary resuscitation chest compressions	Other		Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tidal volume during cardiopulmonary resuscitation	Tidal volume will be assessed by a pneumotachograph (Hans Rudolf USA)	30 seconds

Secondary Outcomes

Measure	Description	Time Frame
Esophageal pressures during cardiopulmonary resuscitation	esophageal pressures will be assessed with an esophageal balloon-catheter that will be introduced via the nares while the patients is still awake and will be positioned at 40 cm from the nares. Correct positioning will be confirmed by the demonstration of negative pressure swings against an occluded airway.	30 seconds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-55 years
ASA I-II
candidates for surgical operation who will receive general anesthesia

Exclusion Criteria:

surgical operation in the chest
musculoskeletal diseases
cardiopulmonary or vascular acute or chronic diseases
history of pneumothorax
thromboembolism
osteoporosis menopause history of current rib or sternal or clavicle fractures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Larissa	Recruiting	Larissa	Thessaly	41110	Greece