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NCT Number: NCT06446544

Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation: a Randomized Study

In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications, particularly infectious ones. During one-lung ventilation, mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity (FRC) which will in turn lead to collapse of the small airways leading to the formation of atelectasis.

Strategies exist to limit the appearance of atelectasis. One of the intraoperative strategies is alveolar recruitment. Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure. Physiologically, alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas. In single-lung ventilation, intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis.

The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume (EFVP), which corresponds to the CRF associated with positive expiratory pressure (PEEP). This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE, thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis. Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient. Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE.

The effectiveness of recruitment maneuvers can be evaluated and quantified (with the Lung Ultrasound Score (LUS)) postoperatively using pleuropulmonary ultrasound. Thus, early ultrasound detection, from the post-interventional monitoring room (SSPI), would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed. A patient could benefit, for example, from prophylactic NIV from the recovery room, from a stricter postural program in a seated position, or from an earlier and/or more intensive respiratory rehabilitation program with the physiotherapy team.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de ROUEN

Rouen, 76031, France

Location contact

Jean Selim, Dr

CONTACT

[email protected]

Jean Selim, Dr

PRINCIPAL_INVESTIGATOR

About this study

In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications, particularly infectious ones. During one-lung ventilation, mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity (FRC) which will in turn lead to collapse of the small airways leading to the formation of atelectasis.

Strategies exist to limit the appearance of atelectasis. One of the intraoperative strategies is alveolar recruitment. Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure. Physiologically, alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas. In single-lung ventilation, intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis.

The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume (EFVP), which corresponds to the CRF associated with positive expiratory pressure (PEEP). This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE, thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis. Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient. Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE.

The effectiveness of recruitment maneuvers can be evaluated and quantified (with the Lung Ultrasound Score (LUS)) postoperatively using pleuropulmonary ultrasound. Thus, early ultrasound detection, from the post-interventional monitoring room (SSPI), would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed. A patient could benefit, for example, from prophylactic NIV from the recovery room, from a stricter postural program in a seated position, or from an earlier and/or more intensive respiratory rehabilitation program with the physiotherapy team.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Adult patient aged 18 to 75 years inclusive
  • Patient requiring lobectomy or segmentectomy by video or robot-thoracoscopy
  • Patient having read and understood the information letter and signed the consent form
  • Patient affiliated to a social security system
  • Women :
  • Of childbearing age (defined by the CTFG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy))
  • using effective contraception according to the WHO (combined hormonal contraception (containing estrogens and progestins), progestin-only contraception, intrauterine device (IUD), male or female condoms) for at least 4 weeks before inclusion and during the study And,
  • Presenting a negative urine pregnancy test at inclusion;
  • Menopause: menopause according to the CTFG is defined as the absence of periods for 12 months without any other medical cause. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal interval can be used to confirm a postmenopausal state in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

Exclusion criteria

  • Patients aged 76 and over
  • COPD patients (Gold stage 3 or 4 of the 2023 Gold classification)
  • Patients with a history of ischemic coronary artery disease
  • Patients with a history of pulmonary emphysema bubbles on the ventilated lung
  • Tracheostomized patient
  • Obese patients (>30 kg/m²)
  • Patients with a history of pulmonary resection
  • ASA patients ≥4
  • Patient benefiting from a pre-operative rehabilitation protocol with physiotherapy
  • Pregnant or parturient or breastfeeding woman or proven absence of contraception
  • Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship
  • History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent
  • Patient refusing to give consent.

Treatment and study plan

VPFE monitoring with intraoperative alveolar recruitment maneuvers.

Procedure

VPFE monitoring with intraoperative alveolar recruitment maneuvers.

Primary outcomes

  1. Evaluate the effect of VPFE monitoring with intraoperative alveolar recruitment maneuvers compared to VPFE monitoring without intraoperative alveolar recruitment maneuvers on pulmonary aeration of the ventilated lung

    Time frame: 30 min post-extubation

    The primary endpoint will be the value of the LUS (Lung Ultrasound Score) score on the ventilated lung at the time of lung ultrasound in SSPI, 30 minutes after extubation (presence of atelectasis with a LUS score > or = 10/18).

Study contacts

Contact information is provided by the study sponsor or research team.

David Mallet

CONTACT

[email protected]

02 32 88 82 65

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: OLVEELV

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 6, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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