Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery Without Capnothorax

• Conditions: Robotic Thoracic Surgery; Mechanical Ventilation; Positive End Expiratory Pressure (PEEP)

• Registration Number: NCT06784037
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

The aim of this study is to assess the impact on lung mechanics during robotic lung resection when no capnothorax is used.

Detailed Description

Assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP without capnothorax. PEEP requirement and lung mechanics without capnothorax will be compared with a historical cohort population of robotic surgery with capnothorax.

Study Timeline

• Study Start: 2024-02-16
• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing uniportal robotic lung resection under no capnothorax

Exclusion Criteria

• Refusal to participate
• Contraindications to recruitment maneuvers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory airway pressures	During intra-operative mechanical ventilation (4 hours)	Respiratory airway pressures (peak pressure, plateau pressure and PEEP in cmH2O)
Respiratory rate	During intra-operative mechanical ventilation (4 hours)	Respiratory rate (in cycles per minute)
Respiratory system compliance	During intra-operative mechanical ventilation (4 hours)	Respiratory pressures measurement will be combined to obtain respiratory system compliance.; Respiratory system compliance = (plateau pressure-PEEP) / respiratory tidal volume (expressed in cmH2O/mL)

Secondary Outcome Measures

Name	Time	Method
Arterial blood gas parameters: pO2	During intra-operative mechanical ventilation (4 hours)	pO2 in mmHg in arterial blood gas sample
Arterial blood gas parameters: pCO2	During intra-operative mechanical ventilation (4 hours)	pCO2 in mmHg in arterial blood gas sample
Arterial blood gas parameters: pH	During intra-operative mechanical ventilation (4 hours)	pH of arterial blood gas samples (no unit can be applied)
Arterial blood gas parameters: sodium bicarbonate	During intra-operative mechanical ventilation (4 hours)	Arterial blood sample sodium bicarbonate concentration (in mmol/L)
Arterial blood gas parameters: base excess	During intra-operative mechanical ventilation (4 hours)	Base excess in arterial blood gas samples in mEq/L

Trial Locations

Locations (1)

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Catalunya, Spain