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OpenTrials
Completed

NCT Number: NCT02158923

Individualized Perioperative Open Lung Ventilatory Strategy

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.

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Key information

Conditions

Moderated-high Risk of Postoperative Pulmonary Complication Abdominal Surgery Expected More Than Two Hours Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Privado de la Comunidad, Mar del Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alveolar Recruitment maneuver

Procedure

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.)

Calculation of optimal PEEP

Procedure

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 .

Postoperative CPAP

Procedure

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.

Primary outcomes

  1. Reduction of lung and systemic postoperative complications

    Time frame: Up to 7 postoperative days

Secondary outcomes

  1. Reduction of lung and systemic postoperative complications

    Time frame: Up to 30 postoperative days

Other outcomes

  1. Mortality evaluation

    Time frame: 180 and 365 days postoperative

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

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

Registry information

Official study title

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

Acronym: iPROVE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2014
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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