Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery. A Single-centre Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Intravenous anesthetic
- Conditions
- Anesthesia
- Sponsor
- Catholic University of the Sacred Heart
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative oxygenation
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Massimo Antonelli
MD, Full Professor, Director of the Department of Anesthesiology and Intensive Care Medicine
Catholic University of the Sacred Heart
Eligibility Criteria
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
Arms & Interventions
Protective ventilation
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.
Intervention: Intravenous anesthetic
Protective ventilation
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.
Intervention: Crystalloid Solutions
Protective ventilation
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.
Intervention: Esophageal pressure measurement
Protective ventilation
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.
Intervention: Lung volume measurement with the nitrogen washin-washout technique
Standard Ventilation
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
Intervention: Intravenous anesthetic
Standard Ventilation
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
Intervention: Crystalloid Solutions
Standard Ventilation
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
Intervention: Esophageal pressure measurement
Standard Ventilation
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
Intervention: Lung volume measurement with the nitrogen washin-washout technique
Outcomes
Primary Outcomes
Postoperative oxygenation
Time Frame: One hour after extubation
PaO2/FiO2 ratio 1 hour after extubation, while the patient is receiving oxygen through VenturiMask 40%
Secondary Outcomes
- Postoperative forced vital capacity (FVC)(48 hours after the end of surgery)
- Postoperative Tiffeneau index(48 hours after the end of surgery)
- Postoperative Dyspnea(1 hour after surgery)
- Postoperative forced expiratory volume in 1 second (FEV1)(48 hours after the end of surgery)
- Pulmonary infection(24 hours after the end of surgery)
- Postoperative pulmonary infiltrates(24 hours after the end of surgery)
- Intraoperative driving pressure(during surgery, recorded on a 60-minute basis)
- Intraoperative lung driving pressure(during surgery, recorded on a 60-minute basis)
- Intraoperative oxygenation(during surgery, recorded on a 60-minute basis)
- Intraoperative dead space(during surgery, recorded on a 60-minute basis)
- Lung recruitment(during surgery, recorded on a 60-minute basis)
- Intraoperative blood pressure(during surgery, recorded on a 60-minute basis)
- Intraoperative respiratory system compliance(during surgery, recorded on a 60-minute basis)
- Intraoperative lung compliance(during surgery, recorded on a 60-minute basis)