None listed
Conditions
Brief summary
Recently, Futier et al. found that the use of a lung-protective ventilation strategy in intermediate-risk and high-risk patients undergoing major abdominal surgery was associated with improved clinical outcomes and reduced health care utilization, as compared with a practice of nonprotective mechanical ventilation (N Engl J Med. 2013 Aug 1;369(5):428-37). Moreover, Severgnini et al. found that a protective ventilation strategy during abdominal surgery lasting more than 2 h improved respiratory function and reduced the modified Clinical Pulmonary Infection Score without affecting length of hospital stay (Anesthesiology. 2013 Jun;118(6):1307-21). However, to date no studies investigate the role of a protective ventilation strategy during neurosurgery. The present pilot study aims to evaluate if a protective ventilation strategy is: 1) safety (i.e. number of intraopeartive complication like desaturation or hypootension) and 2) feasible (i.e. evaluation of the cerebral tension by the surgeon, possibility of optimal control of arterial carbon dioxide) during a major neurosurgery. Secondarily, the study aims to evaluate: 1) if a protective ventilation strategy will translate into reduced number of pulmonary complications (i.e. post-operative hypoxaemia, pneumonia, need of non-invasive or invasive ventilatory support), as assesed through peripheral oxygenation, arterial blood gases and/or chest X-Ray after the surgery, need of oxygen or non-invasive ventilation or invasive ventilation, compared to conventional strategies; 2) if a protective ventilation strategy will translate into reduced number of extra-pulmonary complications (sepsis or septic shock), as assessed by the vital parameters and laboratory blood tests (white blood cell, c-reactive protein, procalcitonin, organ failures indexes), compared to conventional strategies; 3) the ICU, hospital and 30-days mortalities, as assessed through hospital medical records; 4) the number of admission in ICU (together with the reason of admission); 5) the ICU lenght of stay as computed by the total number of days spent in ICU (whenever a patient will be admitted for any reason); 6) the hospital lenght of stay, as computed by the total number of days from the hospital admission to discharge; 7) the impact of the ventilation strategy on the cerebral tension at the beginning of the surgery, as assessed by the surgeon through a dedicated 4-point rating scale, from 0 (i.e. no cerebral tension) to 4 (i.e. severe cerebral tension).
Interventions
The patient randomized in the intervention group will undergo to a protective mechanical ventilation strategy set as described: volume controlled ventilation mode with a Positive End-Expiratory pressure equal to 5 cmH2O, a tidal volume equal to 6 ml/kg of ideal body weight. The respiratory rate will be initially set at 16 breaths/min. After the induction of anesthesia and patient's intubation, and before the beginning of the surgery, a recruitment maneuver will be done applying a pressure to the
The patient randomized in the intervention group will undergo to a protective mechanical ventilation strategy set as described: volume controlled ventilation mode with a Positive End-Expiratory pressure equal to 5 cmH2O, a tidal volume equal to 6 ml/kg of ideal body weight. The respiratory rate will be initially set at 16 breaths/min. After the induction of anesthesia and patient's intubation, and before the beginning of the surgery, a recruitment maneuver will be done applying a pressure to the airway opening equal to 30 cmH2O for a period of 25-30 seconds. Recruitment maneuvers will be done anytime the patient will be deconnected from the ventilator. The treatment will be administered to patients until the end of the surgery and, afterwards, till patients will be awaken from of the anesthesia
Sponsors
Federico Longhini, MD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All the patients meeting the following criteria will be eligible for the study: 1) age equal or greater than 18 years; 2) cerebral or spinal neurosurgery with an expected duration equal or greater than 4 hours, 3) risk index for pulmonary post-operative complications greater than 2; 4) no need for post-operative ICU.
Exclusion criteria
Patients will be excluded if meeting one or more of the following criteria: 1) mechanical ventilation in the previous 2 weeks 2) BMI equal or greater than 35 3) sepsis or acute rspiratory failure in the previous 2 weeks 4) emergent or urgent surgery 5) neuromuscular diseases 6) consent withdraw.
Outcome results
None listed