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Individualized Perioperative Open Lung Ventilatory Strategy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02158923
Acronym
iPROVE
Enrollment
920
Registered
2014-06-09
Start date
2014-09-30
Completion date
2016-04-30
Last updated
2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderated-high Risk of Postoperative Pulmonary Complication, Abdominal Surgery Expected More Than Two Hours

Keywords

ventilation, lung, lung complications, postoperative complications, perioperative lung protective ventilation

Brief summary

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.

Interventions

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.)

PROCEDURECalculation of optimal PEEP

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 .

PROCEDUREPostoperative CPAP

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.

Sponsors

Hospital de Manises
CollaboratorOTHER
Hospital General Valencia
CollaboratorOTHER
Hospital Universitario La Fe
CollaboratorOTHER
Germans Trias i Pujol Hospital
CollaboratorOTHER
Hospital de Sant Pau
CollaboratorOTHER
Hospital del Mar
CollaboratorOTHER
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
CollaboratorOTHER
Hospital General Universitario Gregorio Marañon
CollaboratorOTHER
Hospital General Universitario de Alicante
CollaboratorOTHER
Hospital Juan Canalejo
CollaboratorOTHER
Hospital General Regional de León
CollaboratorOTHER_GOV
Hospital Universitario Virgen de la Arrixaca
CollaboratorOTHER
Hospital Miguel Servet
CollaboratorOTHER
Hospital Clínico Universitario de Valladolid
CollaboratorOTHER
Hospital Universitario Fundación Alcorcón
CollaboratorOTHER
Hospital General de Ciudad Real
CollaboratorOTHER
Hospital Universitario de Valme
CollaboratorOTHER
Hospital de Basurto
CollaboratorOTHER
Hospital Dr. Negrín
CollaboratorUNKNOWN
Hospital de Galdakano
CollaboratorUNKNOWN
Complejo Hospitalario de Especialidades Juan Ramón Jimenez
CollaboratorOTHER
Puerta de Hierro University Hospital
CollaboratorOTHER
Fundación para la Investigación del Hospital Clínico de Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Reduction of lung and systemic postoperative complicationsUp to 7 postoperative days

Secondary

MeasureTime frame
Reduction of lung and systemic postoperative complicationsUp to 30 postoperative days

Other

MeasureTime frame
Mortality evaluation180 and 365 days postoperative

Countries

Argentina, Spain, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026