Development of Pulmonary Dysfunction Following Open Abdominal SurgeryPROVARNCT01683578
Protective Variable Ventilation for Open Abdominal Surgery
A study testing Variable Ventilation in people with Development of Pulmonary Dysfunction Following Open Abdominal Surgery, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Variable ventilation has been shown to improve lung function and reduce lung damage as well as inflammation in different models of the acute respiratory distress syndrome. Also, variable ventilation is able to recruit lungs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Development of Pulmonary Dysfunction Following Open Abdominal Surgery
- What is being tested?
- Variable Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Sep 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective open abdominal surgery
- ASA classification 2-3
- age between 18 und 85 yrs
- expected duration of surgery > 3 h
- expected extubation in the operation room
- written informed consent
Who cannot join
- chronic lung disease (except to COPD stadium I and II, and asthma)
- Body Mass Index (BMI) > 40
- allergy to one of the drugs to be used for general anesthesia
- participation in another interventional trial within 4 weeks before enrollment
- addiction or any other disease that may interfere with the capacity of giving informed consent
- pregnant or breastfeeding women
Show all 14Show fewer
- women in reproductive age, except to those who fulfill one of the following:
- post-menopause (12 months natural amenorrhoea, or 6 months amenorrhoea and serum FSH > 40 mlU/ml
- post-operative (6 weeks after two-sided ovariectomy)
- routine and correct use of anticonceptional methods with failure rate < 1 % per year
- sexually not active
- vasectomy of the partner
- indication of low compliance with the protocol
- contraindication for MRI examination
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
Dresden, Saxony, 01307
About this study
Official title: Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation
Variable ventilation has been shown to improve lung function and reduce lung damage as well as inflammation in different models of the acute respiratory distress syndrome. Also, variable ventilation is able to recruit lungs. The present study will investigate whether variable as compared to non-variable ventilation improves post-operative lung function and reduces systemic inflammation in patients submitted to open abdominal surgery.
- Being tested
- Variable Ventilation
- Keywords
- mechanical ventilation, lung function, abdominal surgery, open, systemic inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable VentilationOther
| Study group | Role | What they receive |
|---|---|---|
| Variable Ventilation | Active comparator | Variable tidal volumes with mean at 8 mL/kg of predicted body weight Receives: Other: Variable Ventilation |
| Non-variable Ventilation | No intervention | Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity
Forced vital capacity is assessed on the first postoperative day
Measured: Preoperative until 5th postoperative day
Secondary outcomes (8)
Arterial partial CO2 pressure
PacO2 on the first postoperative day
Measured: Preoperative until 5th postoperative day
Peak expiratory flow
Measured: Preoperative until 5th postoperative day
Forced expiratory volume after 1 sec
Forced expiratory volume after 1 sec (FEV1) on first postoperative day
Measured: Preoperative until 5th postoperative day
PaO2/FIO2
PaO2/FIO2 during the intraoperative period
Measured: Preoperative until 5th postoperative day
Distribution of ventilation
Distribution of ventilation in lungs
Measured: Preoperative until 5th postoperative day
Atelectasis
Amount of lung atelectasis on the first postoperative day
Measured: Preoperative until 5th postoperative day
Postoperative pulmonary complications
Development of postoperative pulmonary complications
Measured: Preoperative until discharge from hospital
Inflammation markers
Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma
Measured: Preoperative until 5th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionSep 2013
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 Development of Pulmonary Dysfunction Following Open Abdominal SurgeryStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo Gama de Abreu, MD, PhD, Principal investigator, Klinikum Ludwigshafen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683578
- Sponsor's protocol ID
- PulmEngineering-2012-01
- Acronym
- PROVAR
- Status last verified
- Mar 2016
- First submitted
- 3 Sep 2012
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Conrad C, Bischlager K, Braune A, Huhle R, Insorsi A, Tarantino F, Ball L, Schultz MJ, Abolmaali N, Koch T, Pelosi P, Gama de Abreu M; PROtective Ventilation (PROVE) Network. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):581-591. doi: 10.1016/j.bja.2017.11.078. Epub 2017 Dec 1.
PubMed 29452815Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Schultz MJ, Pelosi P, Koch T, Gama de Abreu M. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial. Trials. 2014 May 2;15:155. doi: 10.1186/1745-6215-15-155.
PubMed 24885921
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation
- ClinicalTrials.gov ID
- NCT01683578
- Acronym / sponsor ID
- PROVAR / PulmEngineering-2012-01
- Keywords
- mechanical ventilation, lung function, abdominal surgery, open, systemic inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Sep 2012 (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.
Variable ventilation has been shown to improve lung function and reduce lung damage as well as inflammation in different models of the acute respiratory distress syndrome. Also, variable ventilation is able to recruit lungs. The present study will investigate whether variable as compared to non-variable ventilation improves post-operative lung function and reduces systemic inflammation in patients submitted to open abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Variable Ventilation | Active comparator | Other: Variable VentilationVariable tidal volumes with mean at 8 mL/kg of predicted body weight |
| Non-variable Ventilation | No intervention | –Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- elective open abdominal surgery
- ASA classification 2-3
- age between 18 und 85 yrs
- expected duration of surgery > 3 h
- expected extubation in the operation room
Key exclusion criteria (14 listed)
- chronic lung disease (except to COPD stadium I and II, and asthma)
- Body Mass Index (BMI) > 40
- allergy to one of the drugs to be used for general anesthesia
- participation in another interventional trial within 4 weeks before enrollment
- addiction or any other disease that may interfere with the capacity of giving informed consent
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 |
|---|---|---|
| Variable Ventilation | Other | Variable Ventilation |
Primary outcome
Forced vital capacity
Time frame: Preoperative until 5th postoperative day
Forced vital capacity is assessed on the first postoperative day
8 secondary outcomes
Arterial partial CO2 pressure
Time frame: Preoperative until 5th postoperative day
Peak expiratory flow
Time frame: Preoperative until 5th postoperative day
Forced expiratory volume after 1 sec
Time frame: Preoperative until 5th postoperative day
PaO2/FIO2
Time frame: Preoperative until 5th postoperative day
Distribution of ventilation
Time frame: Preoperative until 5th postoperative day
Atelectasis
Time frame: Preoperative until 5th postoperative day
Postoperative pulmonary complications
Time frame: Preoperative until discharge from hospital
Inflammation markers
Time frame: Preoperative until 5th postoperative day
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 31 Mar 2016.
- Derived from this study: PubMed 29452815Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Conrad C, Bischlager K, Braune A, Huhle R, Insorsi A, Tarantino F, Ball L, Schultz MJ, Abolmaali N, Koch T, Pelosi P, Gama de Abreu M; PROtective Ventilation (PROVE) Network. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):581-591. doi: 10.1016/j.bja.2017.11.078. Epub 2017 Dec 1.
- Derived from this study: PubMed 24885921Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Schultz MJ, Pelosi P, Koch T, Gama de Abreu M. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial. Trials. 2014 May 2;15:155. doi: 10.1186/1745-6215-15-155.
- Homepage of the Pulmonary Engineering Group DresdenLink provided by the sponsor.
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.
Marcelo Gama de Abreu, MD, PhD principal investigator
Klinikum Ludwigshafen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable Ventilation in people with Development of Pulmonary Dysfunction Following Open Abdominal Surgery, run by Technische Universität Dresden at 1 site in Germany.
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 6 inclusion and 14 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 31 Mar 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 Germany. 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?
Forced vital capacity (time frame: Preoperative until 5th postoperative day). 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 NCT01683578, 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 31 Mar 2016.