Lung Protective Ventilation Strategies

NCT ID: NCT06247943

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-03-17

Brief Summary

Obesity is becoming a common condition and bariatric metabolic surgery is one of the main options for treating morbid obesity. However, since most patients undergoing robotic bariatric surgery are class III obese, it brings new challenges to perioperative anesthesia management. Here, we explored the effects of lung-protective ventilation strategies on pulmonary oxygenation function and respiratory mechanics in patients undergoing robotic bariatric surgery.

Detailed Description

Forty obese patients who underwent robotic bariatric surgery in our hospital were selected and randomly divided into a lung-protective ventilation strategy group (Group P) and a control group (Group C). The volume-controlled mode was used to assist ventilation, and the inspiratory/expiratory ratio (I: E) was 1:2. Tidal volume (VT) was set according to the Predicted body weight (PBW) throughout the whole procedure, and in group C, VT was 9 ml /kg without Positive end-expiratory pressure (PEEP), and the inhaled oxygen concentration (Fraction of oxygen) was 0.5 ml /kg, while the inspiratory oxygen concentration (Fraction of oxygen) was 0.5 ml /kg. Group C: VT 9ml /kg, no Positive end-expiratory pressure (PEEP), Fraction of inspiration O2 (FiO2) of 60%; Group P: the ventilation mode was the same as that of Group C from tracheal intubation to the beginning of pneumoperitoneum for 10 minutes, and after 10 minutes of pneumoperitoneum, the ventilation mode was the same as that of Group C. After the pneumoperitoneum for 10 minutes, the ventilation mode was VT 7ml/kg, PEEP 6cmH2O, FiO2 of 40%, and the plateau pressure was maintained at <30cmH2O. In both groups, the intraoperative gas flow was 2L/min, and SpO2 was maintained at ≥95%; if it could not be maintained, the oxygenation function of the patients could be improved by adjusting the ventilation parameters and strategies; meanwhile, the respiratory rate (RR) was adjusted to maintain the End-tidal carbon dioxide partial pressure (PETCO2) at ≥30%, and the end-tidal carbon dioxide partial pressure (PETCO2) was maintained at ≥30%, and the end-tidal carbon dioxide partial pressure (PETCO2) was maintained at ≥30%. The respiratory mechanical parameters: tidal volume, RR, airway peak pressure (PPeak), plateau pressure (PPeak), and plateau pressure (PPeak) were recorded at 5 minutes after tracheal intubation (T0), 10 minutes after the start of the pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the pneumoperitoneum was closed (T4). pressure (PPeak), and plateau pressure (PPlate), and calculate the dynamic lung compliance; arterial blood was drawn at T0, T1, T2, T3, and T4, respectively, and the arterial partial pressure of oxygen (PaO2) and the arterial partial pressure of carbon dioxide (Arterial CO2) were measured. The arterial partial pressure of oxygen (PaO2) and arterial carbon dioxide pressure (PaCO2) were measured, and the oxygenation index (OI) was calculated.

Conditions

Respiration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Lung Protective Ventilation Strategy Group

Use of lung-protective ventilation strategies

Group Type: EXPERIMENTAL

Lung Protective Ventilation Strategy

Intervention Type: PROCEDURE

After 10 minutes of pneumoperitoneum, VT 7 ml/kg was used, PEEP 6 cmH2O, FiO2 was 40%, and plateau pressure \<30 cmH2O was maintained throughout.

Control Group

Use of general ventilation strategies

Group Type: OTHER

regular ventilation

Intervention Type: PROCEDURE

VT 9ml /kg without PEEP, FiO2 of 60%

Interventions

Lung Protective Ventilation Strategy

After 10 minutes of pneumoperitoneum, VT 7 ml/kg was used, PEEP 6 cmH2O, FiO2 was 40%, and plateau pressure \<30 cmH2O was maintained throughout.

Intervention Type: PROCEDURE

regular ventilation

VT 9ml /kg without PEEP, FiO2 of 60%

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Obese patients with ASA grade Ⅰ ~ Ⅲ No obvious abnormality in preoperative lung function and blood gas analysis results Undergoing robotic bariatric surgery

Exclusion Criteria

Had been mechanically ventilated 2 weeks before surgery Thoracic deformity Neuromuscular disease Significant abnormalities in vital organ function Combined pneumothorax or pulmonary herniation Participating in other clinical intervention trials or refusing general anesthesia with tracheal intubation Emergency surgery

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guolin Wang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin Medical University General Hospital

Tianjin, , China

Countries

China

Other Identifiers

GWang026

Identifier Type: -

Identifier Source: org_study_id