Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung Resection Surgery.

NCT05525312 | Recruiting

• 1 other identifier: RECHMPL19_0492
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

During thoracic surgery, one-lung ventilation (OLV) is associated with hypoxemia, lung injury, and perioperative respiratory complications. The level of positive-end expiratory pressure (PEEP) to apply during OLV remains controversial. The open-lung approach consists in setting a level of PEEP corresponding to the best lung compliance, using an esophageal catheter to measure the transpulmonary pressure. This approach has been effective in laparoscopic surgeries or acute respiratory distress syndrome, but has never been evaluated in thoracic surgery.

Conditions

Lung Diseases

Keywords

Pulmonary resection surgery; One lung ventilation; Positive end-expiratory pressure; Esophageal pressure; Transpulmonary pressure; Lung compliance; Protective ventilation; Hypoxemia; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• The incidence of intraoperative hypoxemia

  A SpO2\<92% while the FiO2 is progressively decreased to 50% according to a standardized algorithm.

  During the Open-Lung Ventilation (OLV) period

Secondary Outcomes (17)

• Hypoxemia events

  During the OLV period

• The ventilatory parameters

  T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation

• The ventilatory parameters

  T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation

• The ventilatory parameters

  T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation

• The ventilatory parameters

  T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation

Study Arms (2)

"Standard" protective ventilation

OTHER

Patients receiving a positive-end expiratory pressure (PEEP) of 5 cmH2O

Procedure: "Standard" protective ventilation strategy

"Open lung" protective ventilation protocol

EXPERIMENTAL

Patients with a titrated positive-end expiratory pressure (PEEP) corresponding to the best lung compliance calculated with transpulmonary pressure.

Procedure: "Open-lung" protective ventilation strategy

Interventions

"Open-lung" protective ventilation strategy PROCEDURE

In the "open-lung" group, the positive end-tidal pressure (PEEP) is titrated to match the best lung compliance. During a "PEEP decrement trial", PEEP is decreased from 20 cmH2O to 4 cmH2O by steps of 2 cmH2O/minute, and the driving the transpulmonary pressure (PTP) is calculated at each level of PEEP. In the "open-lung" group, the targeted PEEP corresponds to the lowest driving PTP during the "PEEP decrement trial", meaning the best lung compliance. Thereafter, the PEEP is set at this level and maintained until extubation.

"Open lung" protective ventilation protocol

"Standard" protective ventilation strategy PROCEDURE

In the "standard" group, the positive end-tidal pressure (PEEP) is arbitrarily set at 5 cmH2O, since this is the currently recommended level of PEEP, commonly used in control groups of previous clinical trials.

"Standard" protective ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be over 18 years old,
• To be able to attend all scheduled visits and to comply with all trial procedures,
• To be scheduled for a lung cancer resection surgery (performed by either video-assisted thoracoscopy or thoracotomy).

You may not qualify if:

• Non-carcinologic indication of lung resection (e.g. Lung volume reduction for bullous emphysema reduction, lung abscess),
• Bilateral pulmonary resection surgery or history of lung resection surgery,
• Lung resection under sternotomy
• Non intubated video-assisted thoracoscopy
• Robotic thoracic surgery
• Contraindication to esophageal catheter (history of esophageal varices, hepatic cirrhosis child ≥ b, esophageal or gastric surgery, thoracic radiotherapy, latex allergy),
• ASA (American Society of Anesthesiologists) score ≥ 4,
• Chronic obstructive pulmonary disease GOLD III or IV (Forced Expiratory Volume, FEV\<50%),
• Uncontrolled asthma (FEV \<50%),
• Intracardiac shunt,
• Hemoglobinopathy making the SpO2 values invalid,
• Heart failure NYHA III or IV,
• Documented pulmonary hypertension (Mean Pulmonary Arterial Pressure at rest, mPAP\>20 mmHg),
• To be under legal protection,
• Unable to read or write,

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve

Montpellier, 34090, France

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Hypoxia; Postoperative Complications

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Hélène Dr DAVID

CONTACT

06.65.84.95.24; h-david@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the "standard" protective ventilation versus an "open lung" protective ventilation protocol during a pulmonary resection surgery

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 1, 2022
• Study Start: March 20, 2024
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)