Postoperative ComplicationsPhyCUSNCT03543930
Physiologic Effects of CPAP After Vascular Surgery
An observational study of Postoperative Complications and Respiratory Failure, run by University of Genova at 1 site in Italy.
Trial summary
This study aims to investigate, with a case-crossover design, the effects of a short course of preventive CPAP administered in the immediate postoperative period in patients at high-risk of developing postoperative pulmonary complications undergoing major vascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Respiratory Failure
- What is being tested?
- Postoperative preventive CPAP
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2018to 1 Jul 2019
- 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: Consecutive patients undergoing vascular surgical procedures on the abdominal aorta with open or endovascular approach
Who may be able to join
- Open or endovascular surgery on the abdominal aorta
- Surgical procedure requiring general anaesthesia and invasive intraoperative mechanical ventilation
- Intermediate-high risk of postoperative pulmonary complications (ARISCAT score ≥ 26)
Who cannot join
- Prolonged post-operative invasive ventilation
- Invasive or non-invasive ventilation or oxygen therapy in the last month
- ASA class IV or V
- Emergency procedures
- Pneumothorax or active pulmonary infection
- Any contraindication to CPAP
- Prolonged bed rest
- Patient refusal to participate or to receive preventive CPAP
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico San Martino
Genova, 16132
Paolo Pelosi, Professor, +39 010 5554970, ppelosi@hotmail.com
Paolo Pelosi, Chief of ICU
About this study
This study aims to investigate, with a case-crossover design, the effects of a short course of preventive CPAP administered in the immediate postoperative period in patients at high-risk of developing postoperative pulmonary complications undergoing major vascular surgery.
- Conditions
- Postoperative Complications, Respiratory Failure
- Being tested
- Postoperative preventive CPAP
- Medical subject headings
- Postoperative Complications, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative preventive CPAPDevice
Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2
| Study group | Role | What they receive |
|---|---|---|
| Major open vascular surgery | Surgical procedures on the abdominal aorta requiring median abdominal incision Receives: Device: Postoperative preventive CPAP | |
| Endovascular aortic repair | Abdominal aortic repair with endovascular approach Receives: Device: Postoperative preventive CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FIO2 ratio
Increase of the PaO2/FIO2 ratio compared to the baseline value
Measured: Two hours after the administration of CPAP
Secondary outcomes (1)
Esophageal pressure-time product (PTPes)
Increase of the PTPes compared to the baseline value
Measured: Two hours after the administration of CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start25 May 2018
- Primary completion25 May 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pelosi, University of Genova
- Investigators
- Lorenzo Ball, MD, Principal investigator, Università degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543930
- Sponsor's protocol ID
- PhyCUS Study
- Acronym
- PhyCUS
- Status last verified
- Jun 2018
- First submitted
- 18 May 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Effects of CPAP After Vascular Surgery
- ClinicalTrials.gov ID
- NCT03543930
- Acronym / sponsor ID
- PhyCUS / PhyCUS Study
- Conditions
- Postoperative Complications, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 25 May 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 1 Jun 2018 (actual)
- 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.
This study aims to investigate, with a case-crossover design, the effects of a short course of preventive CPAP administered in the immediate postoperative period in patients at high-risk of developing postoperative pulmonary complications undergoing major vascular surgery.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major open vascular surgery | – | Device: Postoperative preventive CPAPSurgical procedures on the abdominal aorta requiring median abdominal incision |
| Endovascular aortic repair | – | Device: Postoperative preventive CPAPAbdominal aortic repair with endovascular approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing vascular surgical procedures on the abdominal aorta with open or endovascular approach
Key inclusion criteria (3 listed)
- Open or endovascular surgery on the abdominal aorta
- Surgical procedure requiring general anaesthesia and invasive intraoperative mechanical ventilation
- Intermediate-high risk of postoperative pulmonary complications (ARISCAT score ≥ 26)
Key exclusion criteria (8 listed)
- Prolonged post-operative invasive ventilation
- Invasive or non-invasive ventilation or oxygen therapy in the last month
- ASA class IV or V
- Emergency procedures
- Pneumothorax or active pulmonary infection
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 |
|---|---|---|
| Postoperative preventive CPAPAdministration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2 | Device | Endovascular aortic repair, Major open vascular surgery |
Primary outcome
PaO2/FIO2 ratio
Time frame: Two hours after the administration of CPAP
Increase of the PaO2/FIO2 ratio compared to the baseline value
1 secondary outcome
Esophageal pressure-time product (PTPes)
Time frame: Two hours after the administration of CPAP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Lorenzo Ball, MD principal investigator
Università degli Studi di Genova
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 Complications and Respiratory Failure, run by University of Genova 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pelosi, Prof. (+39 335 5941740, ppelosi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FIO2 ratio (time frame: Two hours after the administration of CPAP). 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 3 Jul 2018.