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

Respiratory Physiology Clinical Trial

— ESPIRATOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957045
• Other study ID #: ESPIRATOS
• Status: Completed
• Phase: N/A
• First received: October 17, 2016
• Last updated: November 4, 2016
• Start date: August 2005
• Est. completion date: June 2009

Study information

• Verified date: November 2016
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Respiratory Physiology

Intervention

Procedure:
• Cough pressure measurement

Device:
• Pcough

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough pressure		From baseline until 1 hour	No