Spirometry in Esophageal Intubation | NCT01080508

Studies
Spirometry in Esophageal Intubation

NCT01080508

Sponsor

University Medical Center Groningen

Status

Completed

Last Update Posted

Apr 17, 2024Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Esophageal Intubation

Interventions

tracheal ventilation with regular tube
ventilation after intubation with special tube

Countries

Netherlands

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

Apr 2024

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

Dec 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Mar 3, 2010

First Submission Date that Met QC Criteria

Mar 3, 2010

First Posted Date

Mar 4, 2010Estimated

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

Apr 15, 2024

Last Update Posted Date

Apr 17, 2024Actual

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 primary objective of the study is to describe the pressure patterns during esophageal and tracheal ventilation and to validate the diagnostic algorithm.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1		asa 1&2 patients	Other: tracheal ventilation with regular tube
group 2		asa 1&2 patients	Other: ventilation after intubation with special tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tracheal ventilation with regular tube	Other	Description of the pressure waveforms during tracheal ventilation	group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of the sensitivity and specificity of the algorithm to detect esophageal intubation.		during intubation

Secondary Outcomes

Measure	Description	Time Frame
Pressure pattern of ventilation in esophageal and tracheal ventilation.		during intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients, requiring total anesthesia for a surgical procedure where the use of the easytube could be indicated.

Exclusion Criteria:

ASA III
Expected difficulty for oral intubation.
Expected operation time >3 hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

ASA I & II patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alain F kalmar, Dr.	University Medical Center Groningen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen, University of Groningen, the Netherlands		Groningen			Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22044726	Derived	Kalmar AF, Absalom A, Monsieurs KG. A novel method to detect accidental oesophageal intubation based on ventilation pressure waveforms. Resuscitation. 2012 Feb;83(2):177-82. doi: 10.1016/j.resuscitation.2011.10.009. Epub 2011 Oct 30.