Rate of Reintubation in Mechanically Ventilated Neurosurgical and Neurologic Patients: Evaluation of a Systematic Approach to Weaning and Extubation. A Randomized Controlled Trial

Phase 2

Completed

• Conditions: Mechanically Ventilated Neurosurgical and Neurologic Patients; Neurological - Other surgery

• Registration Number: ACTRN12607000115437
• Lead Sponsor: Azienda Ospedaliera Ospedale Niguarda-Ca’ Granda, Milan, Italy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Considered eligible when 1) had received mechanical ventilation for more than 12 hours, 2) had no need for continuous i.v. sedative infusion and/or controlled mechanical ventilation, 3) were able to trigger the ventilator.

Exclusion Criteria

1) patients admitted already intubated from other institution, 2)presence of tracheotomy, 3) lesion affecting the upper airway, 4) pre-existing decision to withdraw or limit life support, 5)no scheduled surgery in the following 72 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of reintubation secondary to extubation failure. Patients who were not reintubated within 48 hours were considered successfully extubated. All patients were therefore continuously monitored during the 48 hours and were reintubated as soon as they met the predefined criteria for reintubation:1) emergency, such as respiratory or cardiac arrest, and gasping for air, 2) neurological deterioration (coma or agitation requiring continuous sedative intravenousinfusion), 3) hemodynamic instability (i.e. need for continuous catecholamine infusion despite adequate filling or life threatening arrhythmia), 4) upper airway obstruction with stridor and tirage, 5) unmanageable excess of tracheo-bronchial secretions, 6) respiratory distress, as assessed by the combination of SpO2 < 90%, tachypnea (> 35/min), and visible accessory muscle recruitment or thoraco-abdominal paradox, despite maximal oxygen administration and non-invasive ventilation.[Continuously monitored for 48 hours after first attempt of extubation]

Secondary Outcome Measures

Name	Time	Method
Mortality in Intensive Care Unit, rate of tracheotomy in Intensive Care Unit, duration of mechanical ventilation, and length of stay in Intensive Care Unit.[Patients were screened every day for death and tracheotomy. Days spent on mechanical ventilation and length of stay in ICU were determined for all patients when the ICU file was closed (death or ICU discharge). The perception of the protocol by the Intensive Care Unit staff was assessed by means of a Likert-like scale after completion of the study and before analyzing data.]