Pulmonary Ventilation; Newborn, AbnormalNCT03326414
Influence of Different PEEP Levels and Tidal Volumes on Regional Lung Function
A study testing Constant PEEP - low tidal volume, Constant PEEP - high tidal volume and constant tidal volume - low PEEP in people with Pulmonary Ventilation; Newborn, Abnormal, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Mechanical ventilation is indispensable for most of surgical interventions but can induce lung injury even in pulmonary healthy patients. This can lead to postoperative pulmonary complications. These adverse effects could be prevented by a better monitoring of intraoperative lung function. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pulmonary Ventilation; Newborn, Abnormal
- What is being tested?
- Constant PEEP - low tidal volume, Constant PEEP - high tidal volume and constant tidal volume - low PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2018to Jun 2018
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- scheduled for robot assisted prostate ectomy
Who cannot join
- body mass index >35 kg/m²
- chronic obstructive lung disease (GOLD III or IV)
- obstructive sleep apnoe syndrome
- planned or unplanned admission to intensive care unit for prolonged ventilation
- mechanical ventialtion within the last 30 days
- lung operation in the past
- other lung disease that impairs activity
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Hamburg, 20246
About this study
Official title: Influence of Different PEEP Levels and Different Tidal Volumes on Regional Pulmonary Function in Patients Undergoing Robot Assisted Prostatectomy Detected by Electrical Impedance Tomography
Mechanical ventilation is indispensable for most of surgical interventions but can induce lung injury even in pulmonary healthy patients. This can lead to postoperative pulmonary complications. These adverse effects could be prevented by a better monitoring of intraoperative lung function. Electrical impedance tomography is able to visualize aeration within the lung in real time.
The planned study investigates the influence of different levels of positive endexspiratory pressure and different tidal volumes on the aeration.
Read the detailed description
Available perioperative parameters to set mechanical ventilation parameters represent only global lung function. But to reduce postoperative pulmonary complications induced by mechanical ventilation a better monitoring of intraoperative lung function seems to be crucial, that provides more regional information of lung collapse or over distention.
By application of small currents via electrodes around the thorax and measuring of the resultant resistance the electrical impedance tomography (EIT) can determine the level of aeration of the lung in a cross sectional plane. The EIT device used in this study calculates the percentage of the investigated lung area that can be defined as over distended or collapsed respectively. In these sections the change of resistance within a respiration cycle is reduced compared to well ventilated areas are therefore called silent spaces. Silent spaces located ventral are termed non-dependent (NSS) and silent spaces located dorsal are termed dependent (DSS). Based on this information the clinician is able to set the respirator in a more lung protective manor.
To better understand the influence of positive endexspiratory pressure (PEEP) and tidal volume (Vt) on reginal lung function we are going to carry out the presented study.
40 patients undergoing robot assisted prostatectomy should be enrolled in a study that consists of two phases. In the first phase 20 patients are ventilated with constant PEEP (10mbar) and in ten patients each the Vt is set to 5 or 12ml/kg ideal body weight. In the second phase in further 20 patients the Vt is set to 8ml/ kg ideal bodyweight and the PEEP is 3 or 12mbar in one half of the patients. Under the different ventilation settings the NSS and DSS, the oxygenation index and lung compliance will be investigated.
- Conditions
- Pulmonary Ventilation; Newborn, Abnormal
- Being tested
- Constant PEEP - low tidal volume, Constant PEEP - high tidal volume, constant tidal volume - low PEEP, constant tidal volume - high PEEP
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constant PEEP - low tidal volumeProcedure or surgery
The respirator is set according to study protocol
Constant PEEP - high tidal volumeProcedure or surgery
The respirator is set according to study protocol
constant tidal volume - low PEEPProcedure or surgery
The respirator is set according to study protocol
constant tidal volume - high PEEPProcedure or surgery
The respirator is set according to study protocol
| Study group | Role | What they receive |
|---|---|---|
| Constant PEEP - low tidal volume | Other | PEEP is 10mbar, tidal volume is set to 4-5ml/kg IBW Receives: Procedure: Constant PEEP - low tidal volume |
| Constant PEEP - high tidal volume | Other | PEEP is 10mbar, tidal volume is set to 8-10ml/kg IBW Receives: Procedure: Constant PEEP - high tidal volume |
| constant tidal volume - low PEEP | Other | tidal volume is 8ml/kg IBW, PEEP is set to 3mbar Receives: Procedure: constant tidal volume - low PEEP |
| constant tidal volume - high PEEP | Other | tidal volume is 8ml/kg IBW, PEEP is set to 12mbar Receives: Procedure: constant tidal volume - high PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of "dependent silent spaces" (DSS) and "non-dependent silent spaces" (NSS)
The change of silent spaces under different ventilator settings during surgery is investigated.
Measured: measurement of DSS and NSS are carried out prior to induction of anesthesia, 10 minutes after induction, 30 minutes after after installation of capnoperitoneum, 10 minutes after skin closure, 15 minutes after arrival at the PACU
Secondary outcomes (2)
Oxygenation index
The partial pressure of oxygen is determined at every point of measurement and the value is devided by inspiratory oxygen fraction
Measured: prior to induction of anesthesia, 10 minutes after induction, 30 minutes after installation of capnoperitoneum, 10 minutes after skin closure, 15 minutes after arrival at the PACU
complinace of the respiratory system
The compliance of the respiratory system (ml/mbar) is mesured by the respirator during mechanical ventilation
Measured: 10 minutes after induction, 30 minutes after capnoperitoneum applied, 10 minutes after skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study startJan 2018 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionJun 2018 (estimated)
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 Pulmonary Ventilation; Newborn, AbnormalStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Model description
- 40 patients are to be investigated during the project. In phase one 20 patients are ventilated with constant PEEP of 10mbar and the tidal volume is set to 4-5ml/kg IBW or 8-10ml/kg IBW respectively. In phase two further 20 patients are ventilated with a constant tidal volume of 8ml/kg IBW and the PEEP is set to 3mbar or 12mbar respectively.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel A Reuter, MD, Study director, Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Hospital Hamburg-Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326414
- Sponsor's protocol ID
- ANA-UKE-PV5538
- Status last verified
- Oct 2017
- First submitted
- 28 Aug 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not planned to share data with other researchers except data published within an article.
Publications
Canet J, Sabate S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.
PubMed 26020123Ukere A, Marz A, Wodack KH, Trepte CJ, Haese A, Waldmann AD, Bohm SH, Reuter DA. Perioperative assessment of regional ventilation during changing body positions and ventilation conditions by electrical impedance tomography. Br J Anaesth. 2016 Aug;117(2):228-35. doi: 10.1093/bja/aew188.
PubMed 27440635
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different PEEP Levels and Different Tidal Volumes on Regional Pulmonary Function in Patients Undergoing Robot Assisted Prostatectomy Detected by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT03326414
- Acronym / sponsor ID
- ANA-UKE-PV5538
- Conditions
- Pulmonary Ventilation; Newborn, Abnormal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 31 Oct 2017 (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.
Mechanical ventilation is indispensable for most of surgical interventions but can induce lung injury even in pulmonary healthy patients. This can lead to postoperative pulmonary complications. These adverse effects could be prevented by a better monitoring of intraoperative lung function. Electrical impedance tomography is able to visualize aeration within the lung in real time.
The planned study investigates the influence of different levels of positive endexspiratory pressure and different tidal volumes on the aeration.
Detailed description
Available perioperative parameters to set mechanical ventilation parameters represent only global lung function. But to reduce postoperative pulmonary complications induced by mechanical ventilation a better monitoring of intraoperative lung function seems to be crucial, that provides more regional information of lung collapse or over distention.
By application of small currents via electrodes around the thorax and measuring of the resultant resistance the electrical impedance tomography (EIT) can determine the level of aeration of the lung in a cross sectional plane. The EIT device used in this study calculates the percentage of the investigated lung area that can be defined as over distended or collapsed respectively. In these sections the change of resistance within a respiration cycle is reduced compared to well ventilated areas are therefore called silent spaces. Silent spaces located ventral are termed non-dependent (NSS) and silent spaces located dorsal are termed dependent (DSS). Based on this information the clinician is able to set the respirator in a more lung protective manor.
To better understand the influence of positive endexspiratory pressure (PEEP) and tidal volume (Vt) on reginal lung function we are going to carry out the presented study.
40 patients undergoing robot assisted prostatectomy should be enrolled in a study that consists of two phases. In the first phase 20 patients are ventilated with constant PEEP (10mbar) and in ten patients each the Vt is set to 5 or 12ml/kg ideal body weight. In the second phase in further 20 patients the Vt is set to 8ml/ kg ideal bodyweight and the PEEP is 3 or 12mbar in one half of the patients. Under the different ventilation settings the NSS and DSS, the oxygenation index and lung compliance will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 40 patients are to be investigated during the project. In phase one 20 patients are ventilated with constant PEEP of 10mbar and the tidal volume is set to 4-5ml/kg IBW or 8-10ml/kg IBW respectively. In phase two further 20 patients are ventilated with a constant tidal volume of 8ml/kg IBW and the PEEP is set to 3mbar or 12mbar respectively.
| Arm | Type | Receives |
|---|---|---|
| Constant PEEP - low tidal volume | Other | Procedure: Constant PEEP - low tidal volumePEEP is 10mbar, tidal volume is set to 4-5ml/kg IBW |
| Constant PEEP - high tidal volume | Other | Procedure: Constant PEEP - high tidal volumePEEP is 10mbar, tidal volume is set to 8-10ml/kg IBW |
| constant tidal volume - low PEEP | Other | Procedure: constant tidal volume - low PEEPtidal volume is 8ml/kg IBW, PEEP is set to 3mbar |
| constant tidal volume - high PEEP | Other | Procedure: constant tidal volume - high PEEPtidal volume is 8ml/kg IBW, PEEP is set to 12mbar |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years of age
- scheduled for robot assisted prostate ectomy
Key exclusion criteria (7 listed)
- body mass index >35 kg/m²
- chronic obstructive lung disease (GOLD III or IV)
- obstructive sleep apnoe syndrome
- planned or unplanned admission to intensive care unit for prolonged ventilation
- mechanical ventialtion within the last 30 days
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 |
|---|---|---|
| Constant PEEP - low tidal volumeThe respirator is set according to study protocol | Procedure or surgery | Constant PEEP - low tidal volume |
| Constant PEEP - high tidal volumeThe respirator is set according to study protocol | Procedure or surgery | Constant PEEP - high tidal volume |
| constant tidal volume - low PEEPThe respirator is set according to study protocol | Procedure or surgery | constant tidal volume - low PEEP |
| constant tidal volume - high PEEPThe respirator is set according to study protocol | Procedure or surgery | constant tidal volume - high PEEP |
Primary outcome
Change of "dependent silent spaces" (DSS) and "non-dependent silent spaces" (NSS)
Time frame: measurement of DSS and NSS are carried out prior to induction of anesthesia, 10 minutes after induction, 30 minutes after after installation of capnoperitoneum, 10 minutes after skin closure, 15 minutes after arrival at the PACU
The change of silent spaces under different ventilator settings during surgery is investigated.
2 secondary outcomes
Oxygenation index
Time frame: prior to induction of anesthesia, 10 minutes after induction, 30 minutes after installation of capnoperitoneum, 10 minutes after skin closure, 15 minutes after arrival at the PACU
complinace of the respiratory system
Time frame: 10 minutes after induction, 30 minutes after capnoperitoneum applied, 10 minutes after skin closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Background: PubMed 26020123Canet J, Sabate S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.
- Background: PubMed 27440635Ukere A, Marz A, Wodack KH, Trepte CJ, Haese A, Waldmann AD, Bohm SH, Reuter DA. Perioperative assessment of regional ventilation during changing body positions and ventilation conditions by electrical impedance tomography. Br J Anaesth. 2016 Aug;117(2):228-35. doi: 10.1093/bja/aew188.
- Individual participant dataSharing planned: Undecided. It is not planned to share data with other researchers except data published within an article.
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.
Daniel A Reuter, MD study director
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Hospital Hamburg-Eppendorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constant PEEP - low tidal volume, Constant PEEP - high tidal volume and constant tidal volume - low PEEP in people with Pulmonary Ventilation; Newborn, Abnormal, run by Universitätsklinikum Hamburg-Eppendorf 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 2 inclusion and 7 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 31 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander März, MD (+40 40 7410 ext. 54477, a.maerz@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of "dependent silent spaces" (DSS) and "non-dependent silent spaces" (NSS) (time frame: measurement of DSS and NSS are carried out prior to induction of anesthesia, 10 minutes after induction, 30 minutes after after installation of capnoperitoneum, 10 minutes after skin closure, 15 minutes after arrival at the PACU). 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 NCT03326414, 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 Oct 2017.