Endotracheal Suctionning During Positive Pressure Extubation in ICU

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans

About this trial

The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.

Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient

Intubated for more than 48 hours

Patient for whom extubation is prescribed by the patient's physician

Disqualifiers

Headboard restriction>30°.

Decision to limit active treatment in advance of reintubation

Protected person (under guardianship or curatorship)

Person under court protection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suctionning extubation

    Procedure/Surgery

    We will remove the intubation tube with endotracheal suctioning during the extubation procedure and maintain positive end expiratory pressure (PEEP) and pressure support. The PEEP level will be 10 cmH2O and the pressure support 7 cmH2O for 2 minutes prior to extubation. The vacuum level will be the maximum level (standard procedure in the unit), i.e. 450 mmHg. The closed-system suction probe is inserted up to the last mark corresponding to 40cm. The size of our closed system is identical for all patients, i.e. 14 french.

  • No suctionning Extubation

    Procedure/Surgery

    In the control group, removal of the intubation tube during the extubation procedure is performed with PEEP maintained, without endotracheal suctioning. The PEEP level will be set at 10 cmH2O and the pressure at 7 cmH2O in the 2 minutes prior to extubation.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Suctionning Extubation (experimental arm)Experimental treatment 1 intervention
Group B: No Suctionning Extubation (control arm)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Respiratoy/oxygenation index (ROX index)

Rox index will be assessed 3 hours after extubation by an investigator with no information about randomization (blind assessment)

Time frame
3 hours after extubation

Secondary outcomes

1

Mechanical ventilation weaning failure

Weaning failure corresponds with death or new intabution

Time frame
During 7 days after extubation
2

ROX index evolution

Rox index will be assessed 3 times after extubation in order to evaluate its evolution (blind assessment) : 1. 30 minutes after extubation 2. 1 hour after extubation 3. 3 hour after extubation

Time frame
During 3 hours after extubation
3

Pneumonia after extubation

Rate of hospital-acquired pneumonia confirmed by an investigator

Time frame
During 7 days after extubation
4

Airway clearance technique

Use of any airway clearance technique after extubation : * nasotracheal suction * respiratory physiotherapy * bronchial fibroscopy

Time frame
During 24 hours after extubation

Other outcomes

Sponsors and contacts

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