Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery
Not Applicable
Completed
- Conditions
- AnesthesiaSurgery--Complications
- Interventions
- Drug: Intravenous anestheticDrug: Crystalloid SolutionsDiagnostic Test: Esophageal pressure measurementDiagnostic Test: Lung volume measurement with the nitrogen washin-washout technique
- Registration Number
- NCT03157479
- Lead Sponsor
- Catholic University of the Sacred Heart
- Brief Summary
Background. The use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. It is unknown whether such ventilatory approach may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and Trendelenburg position may alter lung volumes and chest-wall elastance.
Objective. The investigators designed a randomized, controlled trial to assess the effect of a lung-protective ventilation strategy on postoperative oxygenation in obese patients undergoing laparoscopic surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
- scheduled for gynaecological laparoscopic surgery in the Trendelenburg position
- Obesity with body mass index>35 kg/m^2
- written informed consent
Exclusion Criteria
- Clinical history or signs of chronic heart failure
- history of neuromuscular disease
- history of thoracic surgery
- pregnancy
- chronic respiratory failure requiring long-term oxygen administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protective ventilation Intravenous anesthetic Volume controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 10 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8 seconds and an inspiratory pause of 0.3 seconds and FiO2 will be kept unchanged during the whole study period. In patients in this group, recruiting maneuvers will be performed throughout a stepwise 5 cmH2O PEEP increase every 30 seconds to achieve a PEEP of 35 cmH2O during Pressure Controlled Ventilation (10 cmH2O of inspiratory pressure while keeping respiratory rate unmodified), followed by a stepwise 5 cmH2O PEEP reduction every 30 seconds until the baseline set peep is reached. Protective ventilation Crystalloid Solutions Volume controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 10 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8 seconds and an inspiratory pause of 0.3 seconds and FiO2 will be kept unchanged during the whole study period. In patients in this group, recruiting maneuvers will be performed throughout a stepwise 5 cmH2O PEEP increase every 30 seconds to achieve a PEEP of 35 cmH2O during Pressure Controlled Ventilation (10 cmH2O of inspiratory pressure while keeping respiratory rate unmodified), followed by a stepwise 5 cmH2O PEEP reduction every 30 seconds until the baseline set peep is reached. Protective ventilation Esophageal pressure measurement Volume controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 10 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8 seconds and an inspiratory pause of 0.3 seconds and FiO2 will be kept unchanged during the whole study period. In patients in this group, recruiting maneuvers will be performed throughout a stepwise 5 cmH2O PEEP increase every 30 seconds to achieve a PEEP of 35 cmH2O during Pressure Controlled Ventilation (10 cmH2O of inspiratory pressure while keeping respiratory rate unmodified), followed by a stepwise 5 cmH2O PEEP reduction every 30 seconds until the baseline set peep is reached. Protective ventilation Lung volume measurement with the nitrogen washin-washout technique Volume controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 10 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8 seconds and an inspiratory pause of 0.3 seconds and FiO2 will be kept unchanged during the whole study period. In patients in this group, recruiting maneuvers will be performed throughout a stepwise 5 cmH2O PEEP increase every 30 seconds to achieve a PEEP of 35 cmH2O during Pressure Controlled Ventilation (10 cmH2O of inspiratory pressure while keeping respiratory rate unmodified), followed by a stepwise 5 cmH2O PEEP reduction every 30 seconds until the baseline set peep is reached. Standard Ventilation Intravenous anesthetic Volume controlled ventilation with tidal volume 10 ml/kg of PBW (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 5 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 mmHg and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8-1 seconds and an inspiratory pause of 0.3 second Standard Ventilation Esophageal pressure measurement Volume controlled ventilation with tidal volume 10 ml/kg of PBW (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 5 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 mmHg and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8-1 seconds and an inspiratory pause of 0.3 second Standard Ventilation Lung volume measurement with the nitrogen washin-washout technique Volume controlled ventilation with tidal volume 10 ml/kg of PBW (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 5 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 mmHg and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8-1 seconds and an inspiratory pause of 0.3 second Standard Ventilation Crystalloid Solutions Volume controlled ventilation with tidal volume 10 ml/kg of PBW (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 5 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 mmHg and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8-1 seconds and an inspiratory pause of 0.3 second
- Primary Outcome Measures
Name Time Method Postoperative oxygenation One hour after extubation PaO2/FiO2 ratio 1 hour after extubation, while the patient is receiving oxygen through VenturiMask 40%
- Secondary Outcome Measures
Name Time Method Postoperative forced vital capacity (FVC) 48 hours after the end of surgery the total amount of air exhaled during a forced expiratory maneuver started from the level of total lung capacity
Postoperative Tiffeneau index 48 hours after the end of surgery computed as FEV1/FVC
Postoperative Dyspnea 1 hour after surgery Dyspnea assessed by Borg dyspnea scale
Postoperative forced expiratory volume in 1 second (FEV1) 48 hours after the end of surgery volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity
Pulmonary infection 24 hours after the end of surgery modified clinical pulmonary infection score (mCPIS)
Postoperative pulmonary infiltrates 24 hours after the end of surgery Evaluated with the chest x-ray by two independent clinicians blinded to treatment assignment
Intraoperative driving pressure during surgery, recorded on a 60-minute basis driving pressure, computed as Plateau pressure-PEEP
Intraoperative lung driving pressure during surgery, recorded on a 60-minute basis transpulmonary driving pressure, computed as Transpulmonary end-inspiratory pressure-transpulmonary total end-expiratory pressure
Intraoperative oxygenation during surgery, recorded on a 60-minute basis PaO2/FiO2
Intraoperative dead space during surgery, recorded on a 60-minute basis Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2
Lung recruitment during surgery, recorded on a 60-minute basis lung recruitment/changes in end expiratory lung volume between the two groups
Intraoperative blood pressure during surgery, recorded on a 60-minute basis Arterial blood pressure
Intraoperative respiratory system compliance during surgery, recorded on a 60-minute basis computed as Tidal volume/airway driving pressure
Intraoperative lung compliance during surgery, recorded on a 60-minute basis computed as Tidal volume/lung driving pressure
Trial Locations
- Locations (1)
General surgery OR, A. Gemelli hospital
🇮🇹Rome, Italy