NCT02957045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

October 17, 2016

Last Update Submit

November 4, 2016

Conditions

Respiratory Physiology

Outcome Measures

Primary Outcomes (1)

  • Cough pressure

    From baseline until 1 hour

Study Arms (1)

Cough

EXPERIMENTAL
Procedure: Cough pressure measurementDevice: Pcough

Interventions

Cough pressure measurementPROCEDURE
Cough
PcoughDEVICE
Cough

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30285741DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator anesthesiologist

Study Record Dates

First Submitted

October 17, 2016

First Posted

November 7, 2016

Study Start

August 1, 2005

Primary Completion

May 1, 2008

Study Completion

June 1, 2009

Last Updated

November 7, 2016

Record last verified: 2016-11

Locations

ES(1)