Back to resultsAlternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure (ESPIRATOS)
Primary Purpose
Respiratory Physiology
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cough pressure measurement
Pcough
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Physiology
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.
Sites / Locations
- Hospital del Mar
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cough
Arm Description
Outcomes
Primary Outcome Measures
Cough pressure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02957045
Brief Title
Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure
Acronym
ESPIRATOS
Official Title
Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Physiology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cough
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cough pressure measurement
Intervention Type
Device
Intervention Name(s)
Pcough
Primary Outcome Measure Information:
Title
Cough pressure
Time Frame
From baseline until 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
30285741
Citation
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.
Results Reference
derived
Learn more about this trial
Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure
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