Mechanical Ventilation ComplicationNCT03635281
Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone in One Lung Ventilation
A study testing Recruitment manoeuvers and incremental PEEP in people with Mechanical Ventilation Complication, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
The intraoperative driving pressure (∆P) has been recently identified as the greater independent predictor of postoperative pulmonary complications after one lung ventilation (OLV). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Recruitment manoeuvers and incremental PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2017to 30 Oct 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing VATS with OLV ≥2 hours
Who cannot join
- ASA (American Society of Anesthesiologists Physical Status Classification) score ≥ 4
- severe chronic respiratory failure (chronic obstructive pulmonary disease patients with GOLD stage 3 or 4
- preoperative hemoglobin less than 10 g ml-1
- hemodynamic instability (defined as a decrease in systolic arterial pressure of more than 20% from baseline),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone on Ventilation Perfusion Mismatch and Respiratory Mechanics in One Lung Ventilation. A Randomized Trial
The intraoperative driving pressure (∆P) has been recently identified as the greater independent predictor of postoperative pulmonary complications after one lung ventilation (OLV). The application of a positive end-expiratory pressure (PEEP) level of 5 or 10 cmH2O has been shown to reduce the ∆P and the V/Q mismatch (Spadaro 2017); however, the "optimal" PEEP level able to minimize the ∆P may change significantly across patients. The aim of this study is to describe the optimal PEEP levels in patients undergoing thoracic surgery
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Recruitment manoeuvers, incremental PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment manoeuversProcedure or surgery
Recruitment manoeuvers will be performed as follow Recruitment manoeuvers
- set FIO2 at 1.0
- Ppeak limit at 45 cmH2O
- Respiratory rate set at 6
- I:E set at 1:1
- Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O
- If the maximum VT is set without rasing the Pplat, raise PEEP
- Allow three respiratory cycles with Pplat between 30 and 40 cmH2O
- End of RM
The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached).
incremental PEEPProcedure or surgery
In this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached
| Study group | Role | What they receive |
|---|---|---|
| PEEP group | Experimental | In this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached) Receives: Procedure: incremental PEEP |
| RM+PEEP group | Experimental | Recruitment maneuvers will be performed as follow Recruitment maneuvers
1. set FIO2 at 1.0
2. Ppeak limit at 45 cmH2O
3. Respiratory rate set at 6
4. I:E set at 1:1
5. Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O
6. If the maximum VT is set without rasing the Pplat, raise PEEP
7. Allow three respiratory cycles with Pplat between 30 and 40 cmH2O
8. End of RM
The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached). Receives: Procedure: Recruitment manoeuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary shunt, expressed as percentage, measured by ALPE system
Measured: 20 minutes after intervention
Secondary outcomes (1)
intraoperative driving pressure, measured as plateau pressure - PEEP
Measured: 20 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Aug 2017
- Primary completion30 Sep 2018
- Study completion30 Oct 2018
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 Mechanical Ventilation ComplicationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savino Spadaro, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635281
- Sponsor's protocol ID
- OLVRM
- Status last verified
- Jan 2019
- First submitted
- 31 Jul 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spadaro S, Grasso S, Karbing DS, Fogagnolo A, Contoli M, Bollini G, Ragazzi R, Cinnella G, Verri M, Cavallesco NG, Rees SE, Volta CA. Physiologic Evaluation of Ventilation Perfusion Mismatch and Respiratory Mechanics at Different Positive End-expiratory Pressure in Patients Undergoing Protective One-lung Ventilation. Anesthesiology. 2018 Mar;128(3):531-538. doi: 10.1097/ALN.0000000000002011.
PubMed 29215365Spadaro S, Grasso S, Karbing DS, Santoro G, Cavallesco G, Maniscalco P, Murgolo F, Di Mussi R, Ragazzi R, Rees SE, Volta CA, Fogagnolo A. Physiological effects of two driving pressure-based methods to set positive end-expiratory pressure during one lung ventilation. J Clin Monit Comput. 2021 Oct;35(5):1149-1157. doi: 10.1007/s10877-020-00582-z. Epub 2020 Aug 20.
PubMed 32816177
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone on Ventilation Perfusion Mismatch and Respiratory Mechanics in One Lung Ventilation. A Randomized Trial
- ClinicalTrials.gov ID
- NCT03635281
- Acronym / sponsor ID
- OLVRM
- Conditions
- Mechanical Ventilation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 17 Aug 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.
The intraoperative driving pressure (∆P) has been recently identified as the greater independent predictor of postoperative pulmonary complications after one lung ventilation (OLV). The application of a positive end-expiratory pressure (PEEP) level of 5 or 10 cmH2O has been shown to reduce the ∆P and the V/Q mismatch (Spadaro 2017); however, the "optimal" PEEP level able to minimize the ∆P may change significantly across patients. The aim of this study is to describe the optimal PEEP levels in patients undergoing thoracic surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP group | Experimental | Procedure: incremental PEEPIn this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached) |
| RM+PEEP group | Experimental | Procedure: Recruitment manoeuversRecruitment maneuvers will be performed as follow Recruitment maneuvers 1. set FIO2 at 1.0 2. Ppeak limit at 45 cmH2O 3. Respiratory rate set at 6 4. I:E set at 1:1 5. Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O 6. If the maximum VT is set without rasing the Pplat, raise PEEP 7. Allow three respiratory cycles with Pplat between 30 and 40 cmH2O 8. End of RM The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing VATS with OLV ≥2 hours
Key exclusion criteria (4 listed)
- ASA (American Society of Anesthesiologists Physical Status Classification) score ≥ 4
- severe chronic respiratory failure (chronic obstructive pulmonary disease patients with GOLD stage 3 or 4
- preoperative hemoglobin less than 10 g ml-1
- hemodynamic instability (defined as a decrease in systolic arterial pressure of more than 20% from baseline),
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 |
|---|---|---|
| Recruitment manoeuversRecruitment manoeuvers will be performed as follow Recruitment manoeuvers 1. set FIO2 at 1.0 2. Ppeak limit at 45 cmH2O 3. Respiratory rate set at 6 4. I:E set at 1:1 5. Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O 6. If the maximum VT is set without rasing the Pplat, raise PEEP 7. Allow three respiratory cycles with Pplat between 30 and 40 cmH2O 8. End of RM The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached). | Procedure or surgery | RM+PEEP group |
| incremental PEEPIn this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached | Procedure or surgery | PEEP group |
Primary outcome
pulmonary shunt, expressed as percentage, measured by ALPE system
Time frame: 20 minutes after intervention
1 secondary outcome
intraoperative driving pressure, measured as plateau pressure - PEEP
Time frame: 20 minutes after intervention
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 Jan 2019.
- Results publication: PubMed 29215365Spadaro S, Grasso S, Karbing DS, Fogagnolo A, Contoli M, Bollini G, Ragazzi R, Cinnella G, Verri M, Cavallesco NG, Rees SE, Volta CA. Physiologic Evaluation of Ventilation Perfusion Mismatch and Respiratory Mechanics at Different Positive End-expiratory Pressure in Patients Undergoing Protective One-lung Ventilation. Anesthesiology. 2018 Mar;128(3):531-538. doi: 10.1097/ALN.0000000000002011.
- Derived from this study: PubMed 32816177Spadaro S, Grasso S, Karbing DS, Santoro G, Cavallesco G, Maniscalco P, Murgolo F, Di Mussi R, Ragazzi R, Rees SE, Volta CA, Fogagnolo A. Physiological effects of two driving pressure-based methods to set positive end-expiratory pressure during one lung ventilation. J Clin Monit Comput. 2021 Oct;35(5):1149-1157. doi: 10.1007/s10877-020-00582-z. Epub 2020 Aug 20.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment manoeuvers and incremental PEEP in people with Mechanical Ventilation Complication, run by Università degli Studi di Ferrara 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 1 inclusion and 4 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 Jan 2019. 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 shunt, expressed as percentage, measured by ALPE system (time frame: 20 minutes after intervention). 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 NCT03635281, 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 Jan 2019.