Back to resultsTotally Transdermal Sedation in the Weaning From Remifentanil Infusion (TOES)
Primary Purpose
Respiratory Insufficiency, Ventilator Weaning, Analgesics, Opioid
Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Fentanyl Transdermal System
Remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Age > 18 yo;
- Negative pregnancy test prior to inclusion in the study;
- The informed consent form needs to be signed and dated by the patient or a relative/legal guardian before of any procedure related to the study; if the patient is initially unable to sign the informed consent form, but later regains the ability to sign it, a new informed consent form will be given to the patient and must be signed and dated;
- Mechanically ventilated in Pressure Support Ventilation, according to the decision to the attending physician;
- A patient with prolonged weaning from the mechanical ventilator will be considered eligible. Prolonged weaning is defined as weaning that is still not terminated 7 days after the first separation attempt from the ventilator (by success or death).
- Analgesia provided by continuous infusion of remifentanil lasting five days or more and an intolerance to a dose reduction of 0.025 mcg/kg/min defined as the presence of at least one of the following criteria: RASS ≥ 2, a respiratory rate ≥ 35 breaths/minute, a PaCO2 < 30 mmHg, a heart rate > 120 bpm, a systolic blood pressure value > 160 mmHg or an increase of Visual Analogue Scale for pain assessment of ≥ 2 points.
Exclusion Criteria:
- Hypersensitivity to the active substance or any of the excipients;
- Hepatic or renal impairment;
- Fever (body temperature ≥ 38 °C) or septic shock, hypothermia (body temperature < 35 °C) or presence of active surface cooling systems;
- Hypercapnic patients with a PaCO2 > 45 mmHg;
- Current enrollment or plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days or 5 half-lives of the agent, prior to the baseline visit;
- Hypoxemic respiratory failure (P/F < 200 mmHg);
- Delirium state defined as RASS ≥ 3 and CAM-ICU positive;
- Hemodynamic instability requiring high doses of inotropes or vasopressors;
- Any condition that may contraindicate the use of remifentanil or transdermal fentanyl;
- Patients with a BMI ≥ 35;
- Patient admitted for postoperative monitoring after elective surgery;
- EAdi catheter contraindicated.
Sites / Locations
- Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
transdermal fentanyl
IV Remifentanil alone
Arm Description
transdermal fentanyl will be administered with a starting dose of 50 mcg/hr simultaneously with the preexistent remifentanil continue infusion. Remifentanil infusion rate will be increased or decreased based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit. After randomization, the transdermal fentanyl dose can be modified every 24 hours according to the study protocol to achieve the desired effect in terms of PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected
remifentanil infusion is administered alone, the infusion rate will be increased or decreased according to the study protocol based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit
Outcomes
Primary Outcome Measures
Comparison of the work of breathing (WOB) of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
To demonstrate that the area under the curve (AUC) of the work of breathing per minute (cmH20*sec/min) (assessed at 1, 6, 12, 24 hours for the first day after randomization, and every 24 hours for the following days) in the intervention group is not higher than the control group.
Comparison of the work of breathing per breath of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
cmH20*sec/min
Comparison of the inspiratory effort of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
cmH20
Comparison of the delta electrical activity of the diaphragm (EAdi) of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
microvolt (mcv)
Comparison of the plateau pressures of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
cmH20
Comparison of driving pressures of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
cmH20
Comparison of transpulmonary driving pressures of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
cmH20
Comparison of the pulmonary compliance of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
ml/cmH20
Comparison of P0.1 of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
cmH20
Comparison of P/F ratios of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
The P/F ratio equals the arterial PaO2 (Arterial Oxygen Partial Pressure) (mmHg) divided by the FIO2 (the fraction of inspired oxygen expressed as a decimal)
Secondary Outcome Measures
Comparison of respiratory rates of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
breaths per minute
Comparison of tidal volumes of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
milliliters
Comparison of arterial blood pressure of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
mmHg
Comparison of heart rates of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
bpm
Global duration of mechanical ventilation among the two groups.
Days
Global duration of intravenous remifentanil infusion among the two groups.
Hours
Length of stay in hospital among the two groups.
Days
Length of stay in ICU among the two groups.
Days
Full Information
NCT ID
NCT04204967
First Posted
December 7, 2019
Last Updated
September 15, 2022
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT04204967
Brief Title
Totally Transdermal Sedation in the Weaning From Remifentanil Infusion
Acronym
TOES
Official Title
Impact of Totally Transdermal Sedation in the Weaning From Remifentanil Infusion Among Critically Ill Patients Undergoing Mechanical Ventilation: a Pilot Randomized-controlled Study (The TOES Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The choice of the sedation protocol has a massive impact on the duration of mechanical ventilation and the timing of extubation. Many sedation protocols are described in the literature. The investigators aim to assess if a transdermal fentanyl-based sedation protocol can have an impact on the global Work of Breathing (WOB)
Detailed Description
The choice of the sedation protocol has a massive impact on the duration of mechanical ventilation and the timing of extubation. Many sedation protocols are described in the literature. No data are available about the possibility of using transdermal fentanyl as an alternative to intravenous opioids during the weaning phase from mechanical ventilation and the post-extubation period until the discharge from ICU to the ward. The investigators aim to assess if a transdermal fentanyl-based sedation protocol can have an impact on the global Work of Breathing (WOB). Secondary endpoints of the study are the duration of mechanical ventilation, the duration of continuous infusion of opioids, the length of stay in ICU and in hospital. Eligible patients will be randomized in 2 groups: Group 1 will receive remifentanil; Group 2 will receive transdermal fentanyl and remifentanil. An Edi Catheter for diaphragm electrical activity monitoring will be put in place for each patient.
Statistical Analysis: Distribution normality will be assessed with the Kolmogorov-Smirnov test. Continuous variables will be reported expressed as medians (interquartile ranges). Qualitative variables will be reported as frequencies. Analysis on the primary efficacy criterion and other quantitative variables will be assessed with the Wilcoxon-Mann-Whitney test. Categorical outcomes will be compared with the chi-square test, or Fisher's exact test, as appropriate. Cochran-Mantel-Haenszel statistics will be reported for all these results. Two-way analysis of variance (ANOVA) for repeated measures with Bonferroni correction will be used to determine the differences in secondary endpoints. Comparisons between groups regarding these variables at each study time point were performed with the Student's t-test or Mann-Whitney test, as appropriate. Mean difference and 95% confidence interval [Confidence Interval 95%] are reported for most significant results. Two-tail p values≤0.05 Will be considered significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Ventilator Weaning, Analgesics, Opioid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
2-arm, single-center, prospective randomized controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transdermal fentanyl
Arm Type
Experimental
Arm Description
transdermal fentanyl will be administered with a starting dose of 50 mcg/hr simultaneously with the preexistent remifentanil continue infusion. Remifentanil infusion rate will be increased or decreased based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit. After randomization, the transdermal fentanyl dose can be modified every 24 hours according to the study protocol to achieve the desired effect in terms of PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected
Arm Title
IV Remifentanil alone
Arm Type
Active Comparator
Arm Description
remifentanil infusion is administered alone, the infusion rate will be increased or decreased according to the study protocol based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit
Intervention Type
Drug
Intervention Name(s)
Fentanyl Transdermal System
Other Intervention Name(s)
Alghedon
Intervention Description
in the experimental arm transdermal fentanyl will be administered with a starting dose of 50 mcg/hr simultaneously with the preexistent remifentanil continue infusion. Remifentanil infusion rate will be increased or decreased based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit. After randomization, the transdermal fentanyl dose can be modified every 24 hours according to the study protocol to achieve the desired effect in terms of PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
In the active comparator arm remifentanil infusion is administered alone, the infusion rate will be increased or decreased according to the study protocol based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit.
In the experimental arm remifentanil is use together with transdermal fentanyl
Primary Outcome Measure Information:
Title
Comparison of the work of breathing (WOB) of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
To demonstrate that the area under the curve (AUC) of the work of breathing per minute (cmH20*sec/min) (assessed at 1, 6, 12, 24 hours for the first day after randomization, and every 24 hours for the following days) in the intervention group is not higher than the control group.
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of the work of breathing per breath of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
cmH20*sec/min
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of the inspiratory effort of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
cmH20
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of the delta electrical activity of the diaphragm (EAdi) of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
microvolt (mcv)
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of the plateau pressures of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
cmH20
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of driving pressures of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
cmH20
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of transpulmonary driving pressures of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
cmH20
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of the pulmonary compliance of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
ml/cmH20
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of P0.1 of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
cmH20
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of P/F ratios of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
The P/F ratio equals the arterial PaO2 (Arterial Oxygen Partial Pressure) (mmHg) divided by the FIO2 (the fraction of inspired oxygen expressed as a decimal)
Time Frame
starts with the randomization and ends 72 hours after randomization
Secondary Outcome Measure Information:
Title
Comparison of respiratory rates of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
breaths per minute
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of tidal volumes of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
milliliters
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of arterial blood pressure of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
mmHg
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Comparison of heart rates of the patients randomized to receive transdermal fentanyl vs. remifentanil alone.
Description
bpm
Time Frame
starts with the randomization and ends 72 hours after randomization
Title
Global duration of mechanical ventilation among the two groups.
Description
Days
Time Frame
starts with the randomization and ends with the discharge from the intensive care unit.
Title
Global duration of intravenous remifentanil infusion among the two groups.
Description
Hours
Time Frame
starts with the randomization and ends with the discharge from the intensive care unit.
Title
Length of stay in hospital among the two groups.
Description
Days
Time Frame
starts with the randomization and ends with the discharge from the Hospital.
Title
Length of stay in ICU among the two groups.
Description
Days
Time Frame
starts with the randomization and ends with the discharge from the intensive care unit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 yo;
Negative pregnancy test prior to inclusion in the study;
The informed consent form needs to be signed and dated by the patient or a relative/legal guardian before of any procedure related to the study; if the patient is initially unable to sign the informed consent form, but later regains the ability to sign it, a new informed consent form will be given to the patient and must be signed and dated;
Mechanically ventilated in Pressure Support Ventilation, according to the decision to the attending physician;
A patient with prolonged weaning from the mechanical ventilator will be considered eligible. Prolonged weaning is defined as weaning that is still not terminated 7 days after the first separation attempt from the ventilator (by success or death).
Analgesia provided by continuous infusion of remifentanil lasting five days or more and an intolerance to a dose reduction of 0.025 mcg/kg/min defined as the presence of at least one of the following criteria: RASS ≥ 2, a respiratory rate ≥ 35 breaths/minute, a PaCO2 < 30 mmHg, a heart rate > 120 bpm, a systolic blood pressure value > 160 mmHg or an increase of Visual Analogue Scale for pain assessment of ≥ 2 points.
Exclusion Criteria:
Hypersensitivity to the active substance or any of the excipients;
Hepatic or renal impairment;
Fever (body temperature ≥ 38 °C) or septic shock, hypothermia (body temperature < 35 °C) or presence of active surface cooling systems;
Hypercapnic patients with a PaCO2 > 45 mmHg;
Current enrollment or plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days or 5 half-lives of the agent, prior to the baseline visit;
Hypoxemic respiratory failure (P/F < 200 mmHg);
Delirium state defined as RASS ≥ 3 and CAM-ICU positive;
Hemodynamic instability requiring high doses of inotropes or vasopressors;
Any condition that may contraindicate the use of remifentanil or transdermal fentanyl;
Patients with a BMI ≥ 35;
Patient admitted for postoperative monitoring after elective surgery;
EAdi catheter contraindicated.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniele Natalini, MD
Phone
00393334055668
Email
daniele.natalini88@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anselmo Caricato, MD
Phone
00393393974355
Email
anselmo.caricato@unicatt.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. A Caricato, MD
Organizational Affiliation
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anselmo Caricato, MD
Phone
00390630153185
Email
Anselmo.Caricato@unicatt.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Totally Transdermal Sedation in the Weaning From Remifentanil Infusion
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