Esophageal Manometry in Mechanically Ventilated Patients | NCT02901158

Studies
Esophageal Manometry in Mechanically Ventilated Patients

NCT02901158

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Oct 11, 2018Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Acute Respiratory Failure

Interventions

Not provided

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

Oct 2018

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 2016Actual

Primary Completion Date

Mar 2018Actual

Completion Date

May 2018Actual

First Submitted Date

Sep 9, 2016

First Submission Date that Met QC Criteria

Sep 14, 2016

First Posted Date

Sep 15, 2016Estimated

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

Oct 10, 2018

Last Update Posted Date

Oct 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stefan Lundin, Professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

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

Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure.

In this study high resolution solid-state manometry technique was used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure.

Detailed Description

In this study high resolution solid-state manometry technique was instead used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. The manometry catheter has 36 circumferential sensors at 1 cm intervals. Each sensor has 12 pressure-sensitive segments that add to the signal at that location. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure. Possible differences in tidal variations in esophageal pressure in different parts of the esophagus were assessed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Critical care patients		Mechanically ventilated patients in the critical care unit
OR-patients		Mechanically ventilated patients in the operating room

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Esophageal pressure measurements in mechanically ventilated patients	Esophageal pressure was measured in mechanically ventilated patients in the critical care unit and in the operating room.	Within one hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients in the critical care unit receiving mechanical ventilation or Patients anesthetized and undergoing surgery

Exclusion Criteria:

Patients with a contraindication to insert a catheter in the esophagus for instance due to an operation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Mechanically ventilated patients in the critical care unit and in the operating room.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Lundin, MD, PhD	Sahlgrenska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital		Gothenburg		S-413 45	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31196203	Derived	Persson P, Ahlstrand R, Gudmundsson M, de Leon A, Lundin S. Detailed measurements of oesophageal pressure during mechanical ventilation with an advanced high-resolution manometry catheter. Crit Care. 2019 Jun 13;23(1):217. doi: 10.1186/s13054-019-2484-8.