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Completed

NCT Number: NCT05077605

Effect of Extubation on Respiratory Function

The extubation phase is a risky period of anesthesia management. During this step, serious complications can arise: hypoxemia, laryngospasm, pharyngeal obstruction, pneumonia… In spite of these complications, extubation and its impact on respiratory function, particularly on the Functional Residual Capacity (FRC), remains poorly studied because of the difficulty to make bedside measurements.

The PulmoVista 500 is a clinical routine which provide effective non-invasive bedside measurements. It would be interesting to evaluate the impact of extubation on respiratory function, and more specifically FRC changes during and after extubation.

This study will allow a better physiopathological knowledge and a quality improvement patient extubation management.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital d'Instruction des Armées de Sainte Anne

Toulon, Var, 83100, France

About this study

The aim of this study is to evaluate the variation of functional residual capacity and its distribution before and after extubation.

Patients with scheduled surgery and receiving general anesthesia with orotracheal intubation are included and the measurements will be performed in the post-interventional monitoring room (PICU). EELI data will be collected before extubation and then at T0, then T5, T10, T15 and T20 minutes. No subsequent follow-up is required.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient over 18 years
  • Patient in operating room for scheduled surgery
  • Patient receiving general anaesthesia with orotracheal intubation
  • Patient given written consent after information
  • Patient covered by social security or equivalent regimen

Exclusion criteria

  • Patient undergoing thoracic and spinal surgery, due to the presence of dressings that interfere with measurements,
  • Patient who has undergone intracerebral surgery because of possible communication difficulties upon awakening,
  • Patients with a body mass index (BMI) > 50 (measurements not possible)
  • Pregnant or breastfeeding patient,
  • Patient contraindicated to the use of a thoracic electroimpedancemetry technique: dressings, wounds, presence of a pacemaker, defibrillator or any other active implant.
  • Patient deprived of liberty by a judicial or administrative decision or patient subject to a legal protection measure (guardianship, curatorship...)
  • Patient in a period of exclusion from another research protocol
  • Any other reason that, in the opinion of the investigator, could interfere with the evaluation of study objectives

Treatment and study plan

Functional residual capacity measure by electrical impedance tomography

Other

Patient functional residual capacity will be measured by electrical impedance tomography before extubation and then at 0, 10, 15 and 20 min after extubation.

Primary outcomes

  1. End Expiratory Lung Impedance (EELI)

    Time frame: Between 2 and 3 hours

    EELI variation before and at different timepoints after extubation: T0, T5, T10, T15 and T20 (min).

Secondary outcomes

  1. Tidal volume distribution

    Time frame: Between 2 and 3 hours

    Percentage of tidal volume in the different regions of interest before extubation and at different timepoints after it: T0, T5, T10, T15 and T20 (min).

  2. Tidal volume distribution depending on patient position

    Time frame: Between 2 and 3 hours

    Percentage of tidal volume according to patient position: supine with or without proclivity, lateral or ventral decubitus

  3. Tidal volume distribution depending on surgery type and duration

    Time frame: Between 2 and 3 hours

    Percentage of tidal volume according to type and duration of surgery

  4. Tidal volume distribution depending on ventilatory mode

    Time frame: Between 2 and 3 hours

    Percentage of tidal volume according to the ventilatory mode: controlled ventilation, spontaneous ventilation with inspiratory assistance, spontaneous ventilation of extubated patient with or without oxygenation device

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

Electrical Impedance Tomography: Effect of Extubation on Functional Residual Capacity

Acronym: PULMOVISTA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2021
Registry last updated
Jul 7, 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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