Expired Study
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Boston, Massachusetts


Purpose:

The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and postoperative individualized ventilatory support will decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all patients at risk.


Criteria:

Inclusion Criteria: - Age not less than 18 - Risk of postoperative pulmonary complication moderate-high defined by a score ≥ 26 on the risk scale ARISCAT (based on the analysis of seven factors, where a score between 26 and 44 points defines a moderate risk, and a score> 44 points define a high risk, included in the Information Booklet Investigator). - Planned abdominal surgery> 2 hours. - Signed informed consent for participation in the study. Exclusion Criteria: - 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. - 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.


Study is Available At:


Original ID:

iPROVE


NCT ID:

NCT02158923


Secondary ID:


Study Acronym:

iPROVE


Brief Title:

Individualized Perioperative Open Lung Ventilatory Strategy


Official Title:

Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fundación para la Investigación del Hospital Clínico de Valencia


Oversight Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Factor


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

920


Enrollment Type:

Actual


Overall Contact Information

Official Name:Carlos Ferrando, MD, PhD
Study Director
Hospital Clínico Universitario Valencia

Study Dates

Start Date:September 2014
Completion Date:April 2016
Completion Type:Actual
Primary Completion Date:April 2016
Primary Completion Type:Actual
Verification Date:May 2016
Last Changed Date:May 14, 2016
First Received Date:June 5, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Reduction of lung and systemic postoperative complications
Time Frame:Up to 30 postoperative days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Reduction of lung and systemic postoperative complications
Time Frame:Up to 7 postoperative days
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Alveolar recruitment maneuver
Description:To start Alveolar Recruitment Maneuver (ARM), change ventilatory pressure-controlled mode (PCV) with 15 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 10 cmH2O. PEEP level will increase 5 on 5 cmH2O every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (25 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)
Arm Name:Individualized ventilation
Intervention Type:Procedure
Name:Calculation of optimal PEEP
Description:Change ventilation mode to volume controlled ventilation (VCV) with a VT of 8 ml / kg, RR 15 rpm and adjust a PEEP of 20 cmH2O. Descend PEEP level 2 by 2 cmH2O every 30 seconds until obtain the best respiratory system compliance (Crs) PEEP. Once you know the optimal level of PEEP (best Crs PEEP), will be conducted again alveolar recruitment maneuver and adjust the best Crs level of PEEP + 2 cmH2O .
Arm Name:Individualized ventilation
Intervention Type:Procedure
Name:Postoperative CPAP
Description:Postoperatively, non-invasive mechanical ventilation with a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied.
Arm Name:Individualized vent. + postop. CPAP

Study Arms

Study Arm Type:Active Comparator
Arm Name:Standard vent. + postoperative CPAP
Description:Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, PEEP 6 cmH2O and FiO2 0.8. In these groups no recruitment maneuvers or optimal PEEP setting will be performed. Postoperatively, a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied.
Study Arm Type:No Intervention
Arm Name:Standard ventilation
Description:Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, PEEP 6 cmH2O and FiO2 0.8. In these groups no recruitment maneuvers or optimal PEEP setting will be performed.
Study Arm Type:Experimental
Arm Name:Individualized vent. + postop. CPAP
Description:Intraoperatively ventilated patients with a tidal volume 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. Pos
Study Arm Type:Experimental
Arm Name:Individualized ventilation
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Fundación para la Investigación del Hospital Clínico de Valencia
Agency Class:Other
Agency Type:Collaborator
Agency Name:Hospital de Manises

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Espósito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
PMID:23093163
Reference Type:Reference
Citation:PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology, Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
PMID:24894577
Reference Type:Reference
Citation: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.
PMID:23902482

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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