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

ConditionLung Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • "Open-lung" protective ventilation strategy

    Procedure/Surgery

    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.

  • "Standard" protective ventilation strategy

    Procedure/Surgery

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: "Standard" protective ventilationOther 1 intervention
Group B: "Open lung" protective ventilation protocolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of intraoperative hypoxemia

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

Time frame
During the Open-Lung Ventilation (OLV) period

Secondary outcomes

1

Hypoxemia events

The number of hypoxemia events, depth, and duration of hypoxemia.

Time frame
During the OLV period
2

The ventilatory parameters

Plateau pressure (mbar)

Time frame
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
3

The ventilatory parameters

Driving PTP (cmH2O)

Time frame
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
4

The ventilatory parameters

Airway driving pressure (cmH2O)

Time frame
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

Other outcomes

Sponsors and contacts

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