PneumoniaNCT01923038
Evaluation of Ventilatory Strategies During Laparoscopic Surgery
A study testing First arm: patients ventilated with zero end expiratory pressure, Patients ventilated with Positive End Expiratory Pressure and Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver in people with Pneumonia, run by Maria Vittoria Hospital at 1 site in Italy.
Trial summary
Atelectasis involving declive areas often occurs during general anesthesia and may persist postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg position. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- First arm: patients ventilated with zero end expiratory pressure, Patients ventilated with Positive End Expiratory Pressure and Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Aug 2013
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society Anesthesiology (ASA) I, II;
- age > 18 years;
- elective surgery
Who cannot join
- ASA III, IV;
- Age < 18 years;
- emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Re-expansion of Atelectasis During Laparoscopic Surgery. Recruitment Maneuver vs Positive End-expiratory Pressure: a Randomized Study
Atelectasis involving declive areas often occurs during general anesthesia and may persist postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress Index (SI), during constant flow inflation can lead ventilator setting during general anesthesia.
- Conditions
- Pneumonia
- Being tested
- First arm: patients ventilated with zero end expiratory pressure, Patients ventilated with Positive End Expiratory Pressure, Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver
- Keywords
- atelectasis, laparoscopic surgery, anesthesia, mechanical ventilation, Prevent, shape of the airway, pressure-time curve
- Medical subject headings
- Pneumonia, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First arm: patients ventilated with zero end expiratory pressureProcedure or surgery
Patients ventilated with Positive End Expiratory PressureProcedure or surgery
Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuverProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients ventilated with zero end expiratory pressure (ZEEP) | Active comparator | patients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure Receives: Procedure: First arm: patients ventilated with zero end expiratory pressure |
| Patients ventilated with positive end expiratory pressure | Active comparator | patients undergoing gynecologic laparoscopic surgery ventilated at PEEP Receives: Procedure: Patients ventilated with Positive End Expiratory Pressure |
| recruitment plus PEEP | Active comparator | patients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP Receives: Procedure: Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Stress Index
Measured: Continuous evaluation during time of surgery. Partecipants will be followed for the duration of hospital stay, an expected average of 1 weeks
Secondary outcomes (1)
Cardiac Index
Measured: Continuous evaluation during the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Vittoria Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilpaolo Manno, Maria Vittoria Hospital
- Investigators
- Emilpaolo Manno, MD, Study director, Maria Vittoria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923038
- Sponsor's protocol ID
- BCB232
- Other IDs
- MariaVittoria Hospital
- Status last verified
- Jan 2014
- First submitted
- 17 May 2013
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-expansion of Atelectasis During Laparoscopic Surgery. Recruitment Maneuver vs Positive End-expiratory Pressure: a Randomized Study
- ClinicalTrials.gov ID
- NCT01923038
- Acronym / sponsor ID
- BCB232
- Conditions
- Pneumonia
- Keywords
- atelectasis, laparoscopic surgery, anesthesia, mechanical ventilation, Prevent, shape of the airway, pressure-time curve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Maria Vittoria HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Aug 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.
Atelectasis involving declive areas often occurs during general anesthesia and may persist postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress Index (SI), during constant flow inflation can lead ventilator setting during general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients ventilated with zero end expiratory pressure (ZEEP) | Active comparator | Procedure: First arm: patients ventilated with zero end expiratory pressurepatients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure |
| Patients ventilated with positive end expiratory pressure | Active comparator | Procedure: Patients ventilated with Positive End Expiratory Pressurepatients undergoing gynecologic laparoscopic surgery ventilated at PEEP |
| recruitment plus PEEP | Active comparator | Procedure: Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuverpatients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society Anesthesiology (ASA) I, II;
- age > 18 years;
- elective surgery
Key exclusion criteria (3 listed)
- ASA III, IV;
- Age < 18 years;
- emergency surgery
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 |
|---|---|---|
| First arm: patients ventilated with zero end expiratory pressure | Procedure or surgery | Patients ventilated with zero end expiratory pressure (ZEEP) |
| Patients ventilated with Positive End Expiratory Pressure | Procedure or surgery | Patients ventilated with positive end expiratory pressure |
| Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver | Procedure or surgery | recruitment plus PEEP |
Primary outcome
Pulmonary Stress Index
Time frame: Continuous evaluation during time of surgery. Partecipants will be followed for the duration of hospital stay, an expected average of 1 weeks
1 secondary outcome
Cardiac Index
Time frame: Continuous evaluation during the time of surgery
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 20 Jan 2014.
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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.
Emilpaolo Manno, MD study director
Maria Vittoria Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First arm: patients ventilated with zero end expiratory pressure, Patients ventilated with Positive End Expiratory Pressure and Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver in people with Pneumonia, run by Maria Vittoria Hospital 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 3 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 20 Jan 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?
Pulmonary Stress Index (time frame: Continuous evaluation during time of surgery. Partecipants will be followed for the duration of hospital stay, an expected average of 1 weeks). 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 20 Jan 2014.