Alternative Measurements of Cough Pressure and Effects of... | NCT02957045

Studies
Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure

NCT02957045

Sponsor

Parc de Salut Mar

Status

Completed

Last Update Posted

Nov 7, 2016Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Respiratory Physiology

Interventions

Cough pressure measurement
Pcough

Countries

Spain

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

Nov 2016

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

Aug 2005

Primary Completion Date

May 2008Actual

Completion Date

Jun 2009Actual

First Submitted Date

Oct 17, 2016

First Submission Date that Met QC Criteria

Nov 4, 2016

First Posted Date

Nov 7, 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

Nov 4, 2016

Last Update Posted Date

Nov 7, 2016Estimated

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

Pressure generated by cough is an expression of expiratory muscle strength. Cough pressure (Pcough) is usually measured with gastric and/or esophageal catheters, but these are often either inconvenient or uncomfortable for the patient. The aim of this study was to evaluate whether central venous, vesical or rectal catheters could be useful to measure cough pressures as alternative sites to standard esophageal and gastric balloons.

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

Label	Type	Description	Intervention Names
Cough	Experimental		Procedure: Cough pressure measurement Device: Pcough

Name	Type	Description	Arm Group Labels	Other Names
Cough pressure measurement	Procedure		Cough
Pcough

Measure	Description	Time Frame
Cough pressure		From baseline until 1 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18 to 75 years and scheduled for colon cancer surgery were recruited.
Informed consent signed.

Exclusion Criteria:

Rectal surgery, advanced cancer, abdominal wall disorders, respiratory or neuromuscular illness, body mass index > 30, chronic pain, pregnancy and inability to cough adequately.

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital del Mar		Barcelona	Barcelona	08003	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30285741	Derived	Aguilera LG, Gallart L, Alvarez JC, Valles J, Gea J. Rectal, central venous, gastric and bladder pressures versus esophageal pressure for the measurement of cough strength: a prospective clinical comparison. Respir Res. 2018 Oct 1;19(1):191. doi: 10.1186/s12931-018-0897-6.