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Completed

NCT Number: NCT05147636

EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit

Extubation in intensive care unit is a risky situation. Its failure is associated with an increase in the duration of mechanical ventilation and high morbidity and mortality.

Our hypothesis is that the extubation procedure associating prior endotracheal aspiration followed by ablation of the intubation probe under the application of a PEEP, would make it possible both to avoid the leakage of secretions towards the lower airways and the alveolar recruitment, compared to extubation with concomitant endotracheal aspiration.

By these mechanisms, this extubation procedure combining prior endotracheal aspiration followed by ablation of the tube under the application of a PEEP, would make it possible to increase the ventilator free days from any mechanical ventilation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Orléans, Orléans, France

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About this study

Extubation consists of several distinct phases: obtaining the weaning criteria, succeeding weaning test and then removing the intubation tube.

While the first two stages are the subject of numerous publications, the last one is rarely studied. To reduce the risk of failure of extubation, the scientific societies of intensive care medicine have published recommendations. They relate to patient weaning and weaning testing, but there are no clear recommendations for the procedure for removing the intubation tube.

The ablation of the tube, performed by the chest physiotherapist or nurse, typically involves endotracheal aspiration, from deflation of the cuff to removal of the intubation tube.

The objective is theoretically to prevent the secretions accumulated above the cuff, at the pharyngeal level, from falling into the lower airways.

Laboratory data show that inhalation of secretions appears to be greater during ablation of the tube with concomitant endotracheal aspiration, which creates a reverse pressure gradient, propelling the secretions into the lower airways. The application of Positive Expiratory Pressure during the ablation of the tube would help to combat this phenomenon. At the same time, this Positive Expiratory Pressure could have a beneficial effect on alveolar recruitment.

Recent work proves the non-inferiority of the ablation of the tube with the application of a Positive Expiratory Pressure versus the so-called "reference" method, consisting of endotracheal aspiration during the ablation of the tube.

We wish to conduct a comparative, prospective, randomized, multicenter study comparing extubation with concomitant endotracheal aspiration versus ablation of the intubation tube under the application of a PEEP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Firstly, the decision to extubate must be made by the treating clinicians after having validated that the clinical criteria for weaning are met, namely: according to the international conference consensus on weaning , patients will be considered as ready for an initial SBT as soon as they meet all of the following criteria:

  • respiratory rate ≤35 breaths per minute,
  • adequate oxygenation defined as pulse oximetry (SpO2 ≥90%) with a fraction of inspired oxygen (FiO2) ≤0.4 or PaO2/FiO2 ≥150 mmHg with positive end-expiratory pressure ≤8 cm H2O,
  • hemodynamic stability with no need for vasopressors (or doses ≤0.3 μg/kg/min),
  • adequate cough,
  • patient awake with a Richmond Agitation-Sedation Scale between +1 and -2

Patients meeting any of the following criteria will be included in the EXSUPEEP trial:

  • ICU Hospitalization
  • Oro-tracheal intubation
  • Mechanical ventilation for more than 24 h
  • First extubation procedure during the stay in the including unit
  • Consent collected from a relative of the patient. Once it has been verified that the patient meets all the eligibility criteria listed above, the patient may be extubated after a successful SBT and after obtaining consent from the patient or family.

Exclusion criteria

Patients meeting any of the following criteria will be excluded from the EXSUPEEP trial:

  • Patients receiving ventilation via tracheostomy.
  • Patients with underlying chronic neuromuscular disease
  • Patients with severe head injury
  • Patients with a decision to withhold and/or withdraw life support
  • Patients not affiliated to or beneficiary of any social security scheme.
  • Person benefiting from enhanced protection, namely minors, pregnant or nursing women, persons deprived of their liberty by a judicial or administrative decision, persons residing in a healthcare or social establishment, adults under legal protection (safeguard of justice, guardianship or curatorship)
  • Inclusion in another research project that interferes with the outcomes of the present study
  • Weanability criteria not met within 72 hours following the signing of consent by the relatives.
  • Unsuccessful weaning test within 72 hours following the signing of consent by the relatives

Patients with personal NIV or continuous positive airway pressure at home will be included if Pressure Support (PS) and/or PEEP used in the ICU unit are different from the usual settings at home. Regarding infection by SARS-CoV-2 or use of endotracheal tubes with subglottic suction, they do not constitute an exclusion criterion.

Treatment and study plan

Extubation with PEEP

Procedure

No aspiration within the 3 minutes before extubation and extubation with 10cmH2O PEEP

Endotracheal Aspiration

Procedure

Aspiration during cuff deflation

Primary outcomes

  1. Ventilator free days at the 28th day

    Time frame: From DZéro to D27

    The primary endpoint is the number of mechanical ventilation-free days (invasive and non-invasive) after the first extubation procedure

Secondary outcomes

  1. Re-intubation rate

    Time frame: 7 days (from Dzéro to D6)

    The re-intubation rate (%) within seven days following the removal of the Extubation Procedure

  2. Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO)

    Time frame: 7 days (from Dzéro to D6)

    Duration marked in hours , same for NIV and HFO

  3. Proportion of patients with pneumonia and/or atelectasis

    Time frame: within 72 hours ( D2) and within 7 days ( D6)

    radiological assessment of pneumonia and/or atelectasis. A systematic chest radiography is to be done at 72 hours and 7 days after extubation procedure.

  4. Rate of Respiratory acute failure (RAF)

    Time frame: Within 7 days (from Dzéro to D6)

    Percentage of included patients who with clinical RAF after extubation procedure

  5. Lenght of stay in Intensive care unit (ICU) and in hospital

    Time frame: within 28 days

    Marked in days.

  6. Rate of death

    Time frame: Within 28 days (from Dzero to Day 27)

    Whatever the cause of death for included patients

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Bourg en Bresse

Other

Collaborators

  • Direction Générale de l'Offre de Soins
  • Hospices Civils de Lyon
  • the EXSUPEEP study was supported by a grant from the French Ministry of Health (MoH-fr)

Registry information

Official study title

EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit: a Multicentre Randomised Controlled Trial.

Acronym: EXSUPEEP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 7, 2021
Registry last updated
Dec 5, 2025

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.