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Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure (ESPIRATOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957045
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Lluís Gallart, Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE November 7, 2016
Last Update Posted Date November 7, 2016
Study Start Date  ICMJE August 2005
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
Cough pressure [ Time Frame: From baseline until 1 hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure
Official Title  ICMJE Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Respiratory Physiology
Intervention  ICMJE
  • Procedure: Cough pressure measurement
  • Device: Pcough
Study Arms  ICMJE Experimental: Cough
Interventions:
  • Procedure: Cough pressure measurement
  • Device: Pcough
Publications * Aguilera LG, Gallart L, Álvarez JC, Vallès 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2016)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02957045
Other Study ID Numbers  ICMJE ESPIRATOS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lluís Gallart, Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Parc de Salut Mar
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP