Impact of totally transdermal sedation in the weaning from remifentanil infusion among critically ill patients undergoing mechanical ventilation: a pilot randomized-controlled Study

Phase 1

• Conditions: Invasive mechanical ventilation is a lifesaving intervention among critically ill patients. However, prolonged ventilation is associated with increased morbidity and mortality. Optimal processes for weaning from ventilation have been studied for many years and have led to evidence-based clinical practice guidelines to facilitate early liberation from invasive mechanical ventilation. It is crucial to avoid prolonged MV, and weaning from the mechanical ventilator should not be delayed.; MedDRA version: 21.1Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002509-22-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•Age > 18 yo
•On Pressure Support Ventilation
•Analgosedation with continuous infusion of remifentanil lasting 5 days or more
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

•Hypoxemic respiratory failure (P/F < 200 mmHg);
•Haemodynamic instability requiring high doses of inotropes or vasopressors;
•Any condition that may contraindicate the use of remifentanil or TTS-fentanyl;
•Patient admitted for post-operative monitoring after elective surgery;
•EAdi catheter contraindicated.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We aim to assess if a TTS fentanyl-based sedation protocol can have an impact on the global Work of Breathing (WOB).;Secondary Objective: Secondary objectives of the study are strudy the duration of mechanical ventilation in patients receiving TTS-fentanyl compared to remifentanil infusion as well the duration of continuous infusion of opioids, the length of stay in ICU and in hospital;Primary end point(s): Primary endpoint is to demonstrate that the area under the curve (AUC) of the work of breathing per minute (assessed at 1, 6, 12, 24, 48 and 72 hours) in the intervention group is not higher than the control group;Timepoint(s) of evaluation of this end point: 72 hours from enrollment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Main secondary endpoints include differences in work of breathing per breath, inspiratory effort, delta EAdi, plateau pressure, driving pressure, transpulmonary driving pressure, pulmonary complicance, P0.1, P/F ratio, respiratory rate, tidal volume, arterial blood pressure, heart rate, global duration of mechanical ventilation, length of stay in ICU and in hospital.;Timepoint(s) of evaluation of this end point: from enrollment to the discharge from the hospital for what concern the global duration of mechanical ventilation, length of stay in ICU and in hospital. 72 hours for the others secondary endpoints