Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery

NCT06026670 | Completed

• 1 other identifier: HCB/2023/0147
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Minimally invasive thoracic surgery is increasingly popular. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation in difficult to access spaces and eliminates tremor which reduces learning curve and it may have a reduction of complications. During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also a continuous tension capnothorax. CO2 insufflation with intrathoracic positive pressure has a potential negative impact on the cardiorespiratory physiology. Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung injury which are related to pulmonary postoperative complications (PPC). In order to reduce PPC and ventilation induced lung injury, lung protective strategies are used which reduce atelectrauma and overdistension. These strategies consist of three main pillars: use of low tidal volumes, performance of recruitment maneuvers and application of optimal positive end-expiratory pressure (PEEP). However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical studies with one-lung ventilation have reported improved oxygenation and ventilation when an alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O. Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation and lung mechanics with individualized PEEP determined by using a PEEP decrement titration trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS may modify pulmonary compliance and optimal PEEP may be different from patients having VATS resection. Even though both methods are habitual in the clinical practice, there are no studies of the effect of an alveolar recruitment maneuver with individualized PEEP during one-lung ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in RATS compared with the establishment of a standardized PEEP. The investigators perform a descriptive observational prospective study to test this hypothesis.

Conditions

Ventilator-Induced Lung Injury

Keywords

Optimal PEEP; Robotic-Assisted Thoracic Surgery.; Recruitment Maneuvers; Mechanical Ventilation; One-lung ventilation; Capnothorax; Positive End-Expiratory Pressure

Outcome Measures

Primary Outcomes (1)

• Optimal PEEP

  Assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP during capnothorax.

  4 hours

Secondary Outcomes (1)

• Perioperative complications

  7 days

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ASA physical status I to III admitted to Hospital Clínic de Barcelona undergoing elective RATS lung resection who agree to participate in the study and sign the written consent form

You may qualify if:

• ASA physical status I to III
• Admitted to Hospital Clínic de Barcelona
• Undergoing elective RATS lung resection
• Who agree to participate in the study and sign the written consent form.

You may not qualify if:

• Patients with age \<18 years
• ASA physical status IV
• Pneumonectomy
• New York Heart Association III to IV
• Preoperative hemoglobin \<10 mg/dL will be excluded from the study.
• Patients in which recruitment maneuvers are contraindicated (history of pneumothorax, contralateral pulmonary bulla, hemodynamic instability, lung emphysema, COPD, bronchopleural fistula, acute cor pulmonale or intracranial hypertension).

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Ricard Navarro

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: September 7, 2023
• Study Start: July 3, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 26, 2024
• Last Updated: February 28, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)