Lung Protective Ventilation Strategies

Lung Protective Ventilation Strategies to Improve Oxygenation Function and Respiratory Mechanics in Patients Undergoing Robotic Bariatric Surgery

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.

Study Overview

• Status: Completed
• Conditions: Respiration
• Intervention / Treatment: Procedure: Lung Protective Ventilation Strategy; Procedure: regular ventilation

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung Protective Ventilation Strategy Group; Use of lung-protective ventilation strategies	Procedure: 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.
Other: Control Group; Use of general ventilation strategies	Procedure: regular ventilation; VT 9ml /kg without PEEP, FiO2 of 60%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenation	Oxygenation index	5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
Respiratory mechanics	plateau airway pressure	5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
oxygenation	arterial oxygen partial pressure	5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
Respiratory mechanics	peak airway pressure	5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
Respiratory mechanics	end-tidal carbon dioxide partial pressure	5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamics	mean arterial pressure	5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)
complications	postoperative pulmonary complications	postoperative days 1, 3, and 5

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): March 16, 2024
• Study Completion (Actual): March 17, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: GWang026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No