The Use of ExPreS - Extubation Predictive Score - in the Weaning of Patients in Invasive Mechanical Ventilation: a Randomized Clinical Trial

1. OBJECTIVES

1. 1 General To evaluate the effect of the Extubation Predictive Score (ExPreS) on the rate of successful extubation.

1.2 Specific To compare the predictive ability of ExPreS with the standard protocol at the study site.

To determine the success and failure rate of extubation within 48 hours according to the protocols used. 2. SELECTION OF PARTICIPANTS The sample will be composed of patients admitted to the ICUs of the participating institutions, on MV for more than 24 hours. Inclusion criteria are pacients admitted to the ICU, older than 18 years and on MV for more than 24 hours. The free and informed consent form must be signed by a family member or responsible adult. Exclusion criteria are death before SBT, tracheostomy, self-extubation, accidental extubation and failure to sign the consent form. The patient who fails extubation and requires reintubation will not be randomized. 3. RANDOMIZATION Patients meeting the criteria for initiation of MV weaning - improvement of the condition causing respiratory failure; arterial oxygen partial pressure higher than 60 mmHg, with inspired oxygen fraction lower than 0. 4 and positive end-expiratory pressure of 5 cm of water or less; hemodynamically stable (no or low dose of vasopressors, absence of decompensated coronary insufficiency or arrhythmias with hemodynamic repercussions); patient's ability to initiate an inspiratory effort; Absence of significant acid-base imbalance, tolerating PSV mode with PEEP of 3-5 and pressure over the PEEP of 7 cmH2O with adequate ventilation (volume of 6 ml/kg and RR ˃ 35/min) - will meet the conditions and will be randomized and submitted to SBT.

Randomization will be performed using the program www.random.org and, for allocation concealment The numbers generated will be placed in sealed and opaque envelopes with the previously defined nomenclature for each group: Group I (T-ayre and standard protocol) and Group II (T-ayre and ExPreS protocol). The envelopes are numbered and placed in order. Therefore, the evaluator and the researchers are prevented from choosing the group to which the individual will be assigned. Only one person will be responsible for opening the envelope and informing the witch group to which he or she has been assigned. 4. INTERVENTION Patients will be assigned to different interventions according to each group. Failure criteria for SBT will be the same for all groups: agitation, anxiety, decreased level of consciousness, respiratory rate higher than 35/min and/or use of accessory muscles, oxygen saturation measured by pulse oxymetry lower than 90% with fraction of inspired oxygen lower than 0.4 more than 0.5, heart rate higher than 140 bpm or an increase higher than 20% of basal, systolic blood pressure (SBP) lower than 90 mmHg or higher than 180 mmHg or presenting arrhythmia after initiation of SBT.