HyperoxiaiPROVE-O2NCT02776046

Individualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2).

A study testing High FiO2 and Conventional FiO2 in people with Hyperoxia and Postoperative Complication, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a perioperative individualized ventilatory strategy to reduce the overall incidence of SSI. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperoxia, Postoperative Complication, Surgical Site Infection
What is being tested?: High FiO2 and Conventional FiO2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 756 participants
Where: 1 siteSpain
Study dates: 1 Jun 2017to Feb 2019
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

Age not less than 18
Planned abdominal surgery> 2 hours.
Signed informed consent for participation in the study.

Who cannot join

Age less than 18 years.
Pregnant or breast-feeding.
Patients with BMI >35.
Syndrome of moderate or severe respiratory distress: PaO2/FiO2 < 200 mmHg.
Heart failure: NYHA IV.
Hemodynamic failure: CI <2.5 L/min/m2 and / or requirements before surgery ionotropic support.

Show all 11Show fewer

Diagnosis or suspicion of intracranial hypertension (intracranial pressure> 15 mmHg).
Mechanical ventilation in the last 15 days.
Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).
Patient with preoperatively CPAP.
Participation in another experimental protocol at the time of intervention selection.

Trial locations and contacts

1 site in 1 country.

Carlos Ferrando, MD, PhD contact

609892732

cafeoranestesia@gmail.com

Spain1 site, 1 recruiting

Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Valencia, 46010
Carlos ferrando, MD, PhD, 609892732, cafeoranestesia@gmail.com
Recruiting

Other trials in Spain

About this study

Official title: Individualized Perioperative Open-luna Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). A Comparative, Prospective, Multicenter, Randomized Controlled Trial

The iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a perioperative individualized ventilatory strategy to reduce the overall incidence of SSI.

Conditions: Hyperoxia, Postoperative Complication, Surgical Site Infection
Being tested: High FiO2, Conventional FiO2
Keywords: Oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy
Medical subject headings: Hyperoxia, Postoperative Complications, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High FiO2Drug
High FiO2 with a perioperative open lung strategy
Conventional FiO2Drug
Conventional FiO2 with a perioperative open lung strategy

Study groups in NCT02776046
Study group	Role	What they receive
High FiO2	Experimental	Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed. Postoperatively 3h with 0.8 FiO2 and individualized CPAP Receives: Drug: High FiO2
Conventional FiO2	Active comparator	Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.3. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed. Postoperatively 3h with 0.3 FiO2 and individualized CPAP Receives: Drug: Conventional FiO2

What is being measured

The primary outcome is the main question the study is designed to answer.

Surgical site infection
Measured: seven postoperative days

Secondary outcomes (3)

Systemic complications
Measured: seven postoperative days
Pulmonary complications
Measured: seven postoperative days
Systemic and pulmonary complications
Measured: thirty postoperative days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 2017Feb 2019

First posted18 May 2016 (estimated)
Study start1 Jun 2017
Primary completionNov 2018 (estimated)
Study completionFeb 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for HyperoxiaStudies 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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 756 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02776046
Sponsor's protocol ID: iPROVE-O2
Acronym: iPROVE-O2
Status last verified: Feb 2018
First submitted: 15 May 2016
Last updated: 26 Feb 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PubMed 23902482
Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035.
PubMed 16249417
Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.
PubMed 19826023
Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.
PubMed 10639541
Ferrando C, Librero J, Tusman G, Serpa-Neto A, Villar J, Belda FJ, Costa E, Amato MBP, Suarez-Sipmann F; iPROVE Network Group. Intraoperative open lung condition and postoperative pulmonary complications. A secondary analysis of iPROVE and iPROVE-O2 trials. Acta Anaesthesiol Scand. 2022 Jan;66(1):30-39. doi: 10.1111/aas.13979. Epub 2021 Sep 22.
PubMed 34460936
Ferrando C, Aldecoa C, Unzueta C, Belda FJ, Librero J, Tusman G, Suarez-Sipmann F, Peiro S, Pozo N, Brunelli A, Garutti I, Gallego C, Rodriguez A, Garcia JI, Diaz-Cambronero O, Balust J, Redondo FJ, de la Matta M, Gallego-Ligorit L, Hernandez J, Martinez P, Perez A, Leal S, Alday E, Monedero P, Gonzalez R, Mazzirani G, Aguilar G, Lopez-Baamonde M, Felipe M, Mugarra A, Torrente J, Valencia L, Varon V, Sanchez S, Rodriguez B, Martin A, India I, Azparren G, Molina R, Villar J, Soro M; iPROVE-O2 Network. Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial. Br J Anaesth. 2020 Jan;124(1):110-120. doi: 10.1016/j.bja.2019.10.009. Epub 2019 Nov 22.
PubMed 31767144
Ferrando C, Soro M, Unzueta C, Canet J, Tusman G, Suarez-Sipmann F, Librero J, Peiro S, Pozo N, Delgado C, Ibanez M, Aldecoa C, Garutti I, Pestana D, Rodriguez A, Garcia Del Valle S, Diaz-Cambronero O, Balust J, Redondo FJ, De La Matta M, Gallego L, Granell M, Martinez P, Perez A, Leal S, Alday K, Garcia P, Monedero P, Gonzalez R, Mazzinari G, Aguilar G, Villar J, Belda FJ; iPROVE-O2 Network Group. Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 31;7(7):e016765. doi: 10.1136/bmjopen-2017-016765.
PubMed 28760799

Want to know more?

Carlos Ferrando, MD, PhD

609892732

cafeoranestesia@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Individualized Perioperative Open-luna Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). A Comparative, Prospective, Multicenter, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02776046
Acronym / sponsor ID: iPROVE-O2 / iPROVE-O2
Conditions: Hyperoxia, Postoperative Complication, Surgical Site Infection
Keywords: Oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 756 participants (estimated)
Lead sponsor: Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
Collaborators: Hospital Universitario La Fe, Hospital General Universitario de Valencia, Hospital de Manises, Hospital de Elche, Hospital de Villajoyosa, Hospital San Pau de Barcelona, Hospital Clinic of Barcelona, Hospital Germans Tríes i Pujol de Badalona, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital General Universitario Gregorio Marañon, Hospital Ramón y Cajal de Madrid, Puerta de Hierro University Hospital, Hospital Universitario Fundación Alcorcón, Hospitales Universitarios Virgen del Rocío, Hospital Son Espases de Mallorca, Hospital Universitario de Gran Canaria Doctor Negrín, Hospital Nuestra Señora de la Candelaria de Santa Cruz de Tenerife, Hospital de Leon, Hospital POVISA de Vigo, Hospital Álvaro Cunqueiro de Vigo, Hospital de Albacete, Hospital Principe de Asturias de Madrid, Hospital Miguel Servet de Zaragoza, Hospital General de Ciudad Real, Hospital Río Hortega de Valladolid
Study start: 1 Jun 2017 (actual)
Primary completion: Nov 2018 (estimated)
Study completion: Feb 2019 (estimated)
First posted: 18 May 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 iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a perioperative individualized ventilatory strategy to reduce the overall incidence of SSI.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
High FiO2	Experimental	Drug: High FiO2Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed. Postoperatively 3h with 0.8 FiO2 and individualized CPAP
Conventional FiO2	Active comparator	Drug: Conventional FiO2Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.3. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed. Postoperatively 3h with 0.3 FiO2 and individualized CPAP

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age not less than 18
Planned abdominal surgery> 2 hours.
Signed informed consent for participation in the study.

Key exclusion criteria (11 listed)

Age less than 18 years.
Pregnant or breast-feeding.
Patients with BMI >35.
Syndrome of moderate or severe respiratory distress: PaO2/FiO2 < 200 mmHg.
Heart failure: NYHA IV.

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
High FiO2High FiO2 with a perioperative open lung strategy	Drug	High FiO2
Conventional FiO2Conventional FiO2 with a perioperative open lung strategy	Drug	Conventional FiO2

Primary outcome

Surgical site infection
Time frame: seven postoperative days

3 secondary outcomes

Systemic complications
Time frame: seven postoperative days
Pulmonary complications
Time frame: seven postoperative days
Systemic and pulmonary complications
Time frame: thirty postoperative days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
Background: PubMed 23902482Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
Background: PubMed 16249417Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035.
Background: PubMed 19826023Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.
Background: PubMed 10639541Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.
Derived from this study: PubMed 34460936Ferrando C, Librero J, Tusman G, Serpa-Neto A, Villar J, Belda FJ, Costa E, Amato MBP, Suarez-Sipmann F; iPROVE Network Group. Intraoperative open lung condition and postoperative pulmonary complications. A secondary analysis of iPROVE and iPROVE-O2 trials. Acta Anaesthesiol Scand. 2022 Jan;66(1):30-39. doi: 10.1111/aas.13979. Epub 2021 Sep 22.
Derived from this study: PubMed 31767144Ferrando C, Aldecoa C, Unzueta C, Belda FJ, Librero J, Tusman G, Suarez-Sipmann F, Peiro S, Pozo N, Brunelli A, Garutti I, Gallego C, Rodriguez A, Garcia JI, Diaz-Cambronero O, Balust J, Redondo FJ, de la Matta M, Gallego-Ligorit L, Hernandez J, Martinez P, Perez A, Leal S, Alday E, Monedero P, Gonzalez R, Mazzirani G, Aguilar G, Lopez-Baamonde M, Felipe M, Mugarra A, Torrente J, Valencia L, Varon V, Sanchez S, Rodriguez B, Martin A, India I, Azparren G, Molina R, Villar J, Soro M; iPROVE-O2 Network. Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial. Br J Anaesth. 2020 Jan;124(1):110-120. doi: 10.1016/j.bja.2019.10.009. Epub 2019 Nov 22.
Derived from this study: PubMed 28760799Ferrando C, Soro M, Unzueta C, Canet J, Tusman G, Suarez-Sipmann F, Librero J, Peiro S, Pozo N, Delgado C, Ibanez M, Aldecoa C, Garutti I, Pestana D, Rodriguez A, Garcia Del Valle S, Diaz-Cambronero O, Balust J, Redondo FJ, De La Matta M, Gallego L, Granell M, Martinez P, Perez A, Leal S, Alday K, Garcia P, Monedero P, Gonzalez R, Mazzinari G, Aguilar G, Villar J, Belda FJ; iPROVE-O2 Network Group. Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 31;7(7):e016765. doi: 10.1136/bmjopen-2017-016765.

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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.

Carlos Ferrando, MD, PhD contact

609892732

cafeoranestesia@gmail.com

Javier Belda, Md, PhD study director

Department of Anesthesia and Critical Care; Hospital Clinico Universitario

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High FiO2 and Conventional FiO2 in people with Hyperoxia and Postoperative Complication, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.

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 11 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 26 Feb 2018. 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 Spain. 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 Carlos Ferrando, MD, PhD (609892732, cafeoranestesia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical site infection (time frame: seven postoperative days). 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 NCT02776046, which also lists 7 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 Feb 2018.