Respiratory PhysiologyESPIRATOSNCT02957045
Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure
A study testing Cough pressure measurement and Pcough in people with Respiratory Physiology, run by Parc de Salut Mar at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Physiology
- What is being tested?
- Cough pressure measurement and Pcough
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2005to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75 years and scheduled for colon cancer surgery were recruited.
- Informed consent signed.
Who cannot join
- Rectal surgery, advanced cancer, abdominal wall disorders, respiratory or neuromuscular illness, body mass index > 30, chronic pain, pregnancy and inability to cough adequately.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Respiratory Physiology
- Being tested
- Cough pressure measurement, Pcough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough pressure measurementProcedure or surgery
PcoughDevice
| Study group | Role | What they receive |
|---|---|---|
| Cough | Experimental | Not described Receives: Procedure: Cough pressure measurement; Device: Pcough |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough pressure
Measured: From baseline until 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startAug 2005
- Primary completionMay 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lluís Gallart, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957045
- Sponsor's protocol ID
- ESPIRATOS
- Acronym
- ESPIRATOS
- Status last verified
- Nov 2016
- First submitted
- 17 Oct 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30285741
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure
- ClinicalTrials.gov ID
- NCT02957045
- Acronym / sponsor ID
- ESPIRATOS / ESPIRATOS
- Conditions
- Respiratory Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cough | Experimental | Procedure: Cough pressure measurement, Device: Pcough |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 75 years and scheduled for colon cancer surgery were recruited.
- Informed consent signed.
Key exclusion criteria (1 listed)
- Rectal surgery, advanced cancer, abdominal wall disorders, respiratory or neuromuscular illness, body mass index > 30, chronic pain, pregnancy and inability to cough adequately.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough pressure measurement | Procedure or surgery | Cough |
| Pcough | Device | Cough |
Primary outcome
Cough pressure
Time frame: From baseline until 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Derived from this study: PubMed 30285741Aguilera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough pressure measurement and Pcough in people with Respiratory Physiology, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough pressure (time frame: From baseline until 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.