Lung CollapseNCT02798133
Open Lung Approach Versus Standard Protective Strategies
A study testing OLA and RM-5 in people with Lung Collapse, run by Fundación para la Investigación del Hospital Clínico de Valencia.
Trial summary
The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low tidal volume (VT) ventilation, with or without an individualized post-RM positive end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Collapse
- What is being tested?
- OLA and RM-5
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection
Who cannot join
- i) laparoscopic surgery, ii) patients with previous respiratory disease.
About this study
Official title: Open Lung Approach Versus Standard Protective Strategies: Effects on Driving Pressure and Ventilatory Efficiency During Anesthesia
The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low tidal volume (VT) ventilation, with or without an individualized post-RM positive end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.
- Conditions
- Lung Collapse
- Being tested
- OLA, RM-5
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLAProcedure or surgery
PEEP titration trial for best Cdyn after the alveolar recruitment maneuver
RM-5Procedure or surgery
Fixed standard PEEP after the alveolar recruitment maneuver
| Study group | Role | What they receive |
|---|---|---|
| OLA | Experimental | recruitment maneuver + individualized PEEP Receives: Procedure: OLA |
| RM-5 | Active comparator | recruitment maneuver + fixed standard PEEP Receives: Procedure: RM-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
driving pressure
The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications
Measured: intraoperative
Secondary outcomes (1)
ventilatory efficiency
Ventilatory efficiency measured with volumetric capnography which includes dead space and tidal elimination of carbon dioxide.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CollapseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798133
- Sponsor's protocol ID
- OLA
- Status last verified
- Apr 2017
- First submitted
- 5 Jun 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.
PubMed 26947624Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.
PubMed 26672923Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
PubMed 24557111Zorrilla-Vaca A, Zapata-Pena DA, Allen MB, Linares M, Sanahuja P, Librero J, Ferrando C; iPROVE Study Group Collaborators. Intraoperative corticosteroid administration and postoperative pulmonary complications: a secondary analysis of the iPROVE clinical trials. Br J Anaesth. 2026 Aug 27:S0007-0912(26)00583-0. doi: 10.1016/j.bja.2026.08.001. Online ahead of print.
PubMed 42660722Ferrando C, Suarez-Sipmann F, Tusman G, Leon I, Romero E, Gracia E, Mugarra A, Arocas B, Pozo N, Soro M, Belda FJ. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177399. doi: 10.1371/journal.pone.0177399. eCollection 2017.
PubMed 28493943
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Lung Approach Versus Standard Protective Strategies: Effects on Driving Pressure and Ventilatory Efficiency During Anesthesia
- ClinicalTrials.gov ID
- NCT02798133
- Acronym / sponsor ID
- OLA
- Conditions
- Lung Collapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Jun 2016 (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.
The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low tidal volume (VT) ventilation, with or without an individualized post-RM positive end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLA | Experimental | Procedure: OLArecruitment maneuver + individualized PEEP |
| RM-5 | Active comparator | Procedure: RM-5recruitment maneuver + fixed standard PEEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-III undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection
Key exclusion criteria (1 listed)
- i) laparoscopic surgery, ii) patients with previous respiratory disease.
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 |
|---|---|---|
| OLAPEEP titration trial for best Cdyn after the alveolar recruitment maneuver | Procedure or surgery | OLA |
| RM-5Fixed standard PEEP after the alveolar recruitment maneuver | Procedure or surgery | RM-5 |
Primary outcome
driving pressure
Time frame: intraoperative
The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications
1 secondary outcome
ventilatory efficiency
Time frame: intraoperative
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 26 Apr 2017.
- Background: PubMed 26947624Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.
- Background: PubMed 26672923Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.
- Background: PubMed 24557111Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
- Derived from this study: PubMed 42660722Zorrilla-Vaca A, Zapata-Pena DA, Allen MB, Linares M, Sanahuja P, Librero J, Ferrando C; iPROVE Study Group Collaborators. Intraoperative corticosteroid administration and postoperative pulmonary complications: a secondary analysis of the iPROVE clinical trials. Br J Anaesth. 2026 Aug 27:S0007-0912(26)00583-0. doi: 10.1016/j.bja.2026.08.001. Online ahead of print.
- Derived from this study: PubMed 28493943Ferrando C, Suarez-Sipmann F, Tusman G, Leon I, Romero E, Gracia E, Mugarra A, Arocas B, Pozo N, Soro M, Belda FJ. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177399. doi: 10.1371/journal.pone.0177399. eCollection 2017.
- Individual participant dataSharing planned: Yes
Related trials for Lung Collapse
RecruitingObservational study
Physiological Finding in Management of COVID 19 Patients
COVID-19 (Coronavirus Disease 2019)
RecruitingObservational study
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
Septic Shock
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Active, not recruitingObservational study
Real-World Use of Tarlatamab in Chinese Patients With Small-Cell Lung Cancer
Extensive-Stage Small Cell Lung Cancer
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.
Questions about this trial
What is this clinical trial studying?
A study testing OLA and RM-5 in people with Lung Collapse, run by Fundación para la Investigación del Hospital Clínico de Valencia.
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 1 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
driving pressure (time frame: intraoperative). 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 NCT02798133, which also lists 5 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 26 Apr 2017.