Clinical trial NCT05147636: EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit
Official title: EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit: a Multicentre Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extubation in Intensive Care Unit
Keywords: extubation
intensive care
endotracheal aspiration
positive end expiratory pressure
non invasive ventilation
Lead sponsor: Centre Hospitalier de Bourg en Bresse
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
name: Hospices Civils de Lyon
First posted: 2021-12-07
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ventilator free days at the 28th day
timeFrame: From DZéro to D27
Secondary outcomes:
measure: Re-intubation rate
timeFrame: 7 days (from Dzéro to D6)
measure: Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO)
timeFrame: 7 days (from Dzéro to D6)
measure: Proportion of patients with pneumonia and/or atelectasis
timeFrame: within 72 hours ( D2) and within 7 days ( D6)
measure: Rate of Respiratory acute failure (RAF)
timeFrame: Within 7 days (from Dzéro to D6)
measure: Lenght of stay in Intensive care unit (ICU) and in hospital
timeFrame: within 28 days
measure: Rate of death
timeFrame: Within 28 days (from Dzero to Day 27)
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH Annecy Genevois
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Bourg en Bresse
country: France
facility: CH Bourg en Bresse
city: Dijon
country: France
facility: CHU Francois Mitterand
city: Grenoble
country: France
facility: CHU Michallon
city: Lyon
country: France
facility: HCL Croix Rousse
city: Lyon
country: France
facility: HCL Edouard Herriot
city: Lyon
country: France
facility: HCL Lyon Sud
city: Orléans
country: France
facility: CHU Orléans
city: Poitiers
country: France
facility: CHU La Miletrie
city: Saint-Étienne
country: France
facility: Hopital Nord
Study officials:
affiliation: CH Bourg en Bresse
name: Nicholas SEDILLOT
role: PRINCIPAL_INVESTIGATOR
References: