Continuous Positive Airway Pressure [E02.041.625.790.259]NCT01956422
Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy
A study testing Continuous Positive Airway Pressure(CPAP) and Venturi Mask FiO2 40% in people with Continuous Positive Airway Pressure [E02.041.625.790.259] and Prostatectomy [E04.950.774.860.625], run by ASST Fatebenefratelli Sacco at 1 site in Italy.
Trial summary
Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may reduce the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (PaO2<60 mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of basal value. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Continuous Positive Airway Pressure [E02.041.625.790.259], Prostatectomy [E04.950.774.860.625], Laparoscopy [E01.370.388.250.520]
- What is being tested?
- Continuous Positive Airway Pressure(CPAP) and Venturi Mask FiO2 40%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2013to Jul 2014
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective laparoscopic prostatectomy
- American Society of Anesthesiologists status I-II
Who cannot join
- Cardiac functional status New York Heart Association (NYHA) >II
- Chronic Obstructive Pulmonary Disease (COPD) Gold Class >2
Trial locations and contacts
1 site in 1 country.
About this study
Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may reduce the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (PaO2<60 mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of basal value.
Read the detailed description
Laparoscopic radical prostatectomy (LRP) is a wide used, well tolerated procedure. However, the general anesthesia, the need for pneumoperitoneum and Trendelenburg position may have detrimental effects on both pulmonary volumes and mechanics, and they may increase the risk of postoperative respiratory failure (PORF). Continuous positive airway pressure (CPAP) improves oxygenation and reduces the rate of re-intubation in the presence of PORF.
The aim of our study is to investigate postoperative respiratory function and the likely benefits of the use of CPAP, compared with Venturi mask in terms of prevention of post-operative hypoxaemia and worsening of lung spirometry.
CPAP is delivered with "CASTAR" Helmet by StarMed.
- Conditions
- Continuous Positive Airway Pressure [E02.041.625.790.259], Prostatectomy [E04.950.774.860.625], Laparoscopy [E01.370.388.250.520], Pneumoperitoneum [C06.844.670]
- Being tested
- Continuous Positive Airway Pressure(CPAP), Venturi Mask FiO2 40%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure(CPAP)Device
Venturi Mask FiO2 40%Device
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure(CPAP) | Experimental | In the first 24 hours after laparoscopic prostatectomy patients undergo 3 CPAP cycles (PEEP 7.5, FIO2 40% delivered with Helmet)lasting 2 hours. Receives: Device: Continuous Positive Airway Pressure(CPAP) |
| Venturi Mask FiO2 40% | Active comparator | In the first 24 hours after laparoscopic prostatectomy patients breathe Oxygen 40% delivered with Venturi Mask Receives: Device: Venturi Mask FiO2 40% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)
Measured: 24 hours after the end of surgery
Secondary outcomes (1)
Incidence of pneumonia
Measured: Partecipants will be followed for the duration of hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Continuous Positive Airway Pressure [E02.041.625.790.259]Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Fossali, ASST Fatebenefratelli Sacco
- Investigators
- Tommaso Fossali, Consultant, Principal investigator, ASST Fatebenefratelli Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956422
- Sponsor's protocol ID
- CE#382/2013
- Status last verified
- Jul 2014
- First submitted
- 27 Sep 2013
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829.
PubMed 18362624Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM; Piedmont Intensive Care Units Network (PICUN). Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. JAMA. 2005 Feb 2;293(5):589-95. doi: 10.1001/jama.293.5.589.
PubMed 15687314
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01956422
- Acronym / sponsor ID
- CE#382/2013
- Conditions
- Continuous Positive Airway Pressure [E02.041.625.790.259], Prostatectomy [E04.950.774.860.625], Laparoscopy [E01.370.388.250.520], Pneumoperitoneum [C06.844.670]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Oct 2013 (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.
Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may reduce the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (PaO2<60 mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of basal value.
Detailed description
Laparoscopic radical prostatectomy (LRP) is a wide used, well tolerated procedure. However, the general anesthesia, the need for pneumoperitoneum and Trendelenburg position may have detrimental effects on both pulmonary volumes and mechanics, and they may increase the risk of postoperative respiratory failure (PORF). Continuous positive airway pressure (CPAP) improves oxygenation and reduces the rate of re-intubation in the presence of PORF.
The aim of our study is to investigate postoperative respiratory function and the likely benefits of the use of CPAP, compared with Venturi mask in terms of prevention of post-operative hypoxaemia and worsening of lung spirometry.
CPAP is delivered with "CASTAR" Helmet by StarMed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure(CPAP) | Experimental | Device: Continuous Positive Airway Pressure(CPAP)In the first 24 hours after laparoscopic prostatectomy patients undergo 3 CPAP cycles (PEEP 7.5, FIO2 40% delivered with Helmet)lasting 2 hours. |
| Venturi Mask FiO2 40% | Active comparator | Device: Venturi Mask FiO2 40%In the first 24 hours after laparoscopic prostatectomy patients breathe Oxygen 40% delivered with Venturi Mask |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective laparoscopic prostatectomy
- American Society of Anesthesiologists status I-II
Key exclusion criteria (2 listed)
- Cardiac functional status New York Heart Association (NYHA) >II
- Chronic Obstructive Pulmonary Disease (COPD) Gold Class >2
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 |
|---|---|---|
| Continuous Positive Airway Pressure(CPAP) | Device | Continuous Positive Airway Pressure(CPAP) |
| Venturi Mask FiO2 40% | Device | Venturi Mask FiO2 40% |
Primary outcome
Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)
Time frame: 24 hours after the end of surgery
1 secondary outcome
Incidence of pneumonia
Time frame: Partecipants will be followed for the duration of hospital stay, an expected average of 1 week
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 11 Jul 2014.
- Background: PubMed 18362624Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829.
- Background: PubMed 15687314Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM; Piedmont Intensive Care Units Network (PICUN). Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. JAMA. 2005 Feb 2;293(5):589-95. doi: 10.1001/jama.293.5.589.
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.
Tommaso Fossali, Consultant principal investigator
ASST Fatebenefratelli Sacco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure(CPAP) and Venturi Mask FiO2 40% in people with Continuous Positive Airway Pressure [E02.041.625.790.259] and Prostatectomy [E04.950.774.860.625], run by ASST Fatebenefratelli Sacco 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 11 Jul 2014. 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?
Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline) (time frame: 24 hours after the end of surgery). 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 NCT01956422, which also lists 2 linked publications.
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 11 Jul 2014.