Postoperative Respiratory ComplicationsNCT02229591
Expiratory Flow Limitation and Postoperative Complications
An observational study of Postoperative Respiratory Complications, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles dysfunction, and progressive neuroventilatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Respiratory Complications
- How many people
- 330 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Sep 2016
- Phase
- Observational
- 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
Study population: Patients undergoing abdominal, thyroid or vascular surgery in Sant'Anna Hospital
Who may be able to join
- General anesthesia
- Duration of the surgery >2 hours
Who cannot join
- <18 years
- Consensus not given
Trial locations and contacts
1 site in 1 country.
About this study
Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis is that EFL should affect post operative outcomes like incidence of pulmonary complication and length of stay in hospital
- Conditions
- Postoperative Respiratory Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EFL patients | Patients with Expiratory Flow Limitation undergoing surgery | |
| Control group | Patients withouth Expiratory Flow Limitation undergoing surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary complication
Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startJan 2013
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Respiratory ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savino Spadaro, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229591
- Sponsor's protocol ID
- 17082014
- Status last verified
- Oct 2016
- First submitted
- 28 Aug 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expiratory Flow Limitation and Postoperative Complications
- ClinicalTrials.gov ID
- NCT02229591
- Acronym / sponsor ID
- 17082014
- Conditions
- Postoperative Respiratory Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Sep 2014 (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.
Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis is that EFL should affect post operative outcomes like incidence of pulmonary complication and length of stay in hospital
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFL patients | – | –Patients with Expiratory Flow Limitation undergoing surgery |
| Control group | – | –Patients withouth Expiratory Flow Limitation undergoing surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing abdominal, thyroid or vascular surgery in Sant'Anna Hospital
Key inclusion criteria (2 listed)
- General anesthesia
- Duration of the surgery >2 hours
Key exclusion criteria (2 listed)
- <18 years
- Consensus not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary complication
Time frame: 28 days
Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation
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 26 Oct 2016.
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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?
An observational study of Postoperative Respiratory Complications, run by Università degli Studi di Ferrara at 1 site in Italy.
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 2 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 26 Oct 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 Italy. 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?
Pulmonary complication (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2016.