Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

T-piece Versus Pressure-support for the Spontaneous Breathing Trial (TiP-Ex)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227639
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials.

To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit.

Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.


Condition or disease Intervention/treatment Phase
Weaning From Mechanical Ventilation Extubation Procedure: T-piece trial Procedure: Pressure-support trial Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: T-piece Versus Pressure-support for the Spontaneous Breathing Trial Before Extubation in Patients at High-risk of Reintubation: a Multicenter Randomized Controlled Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Active Comparator: T-piece trial
In patients assigned to control group all spontaneous breathing trials will be performed using T-piece trial.
Procedure: T-piece trial
T-piece trial will be performed for around 1 hour with a T-piece connected to the extremity of the endotracheal tube by simply disconnecting the patient from the ventilator and by providing additional oxygen (≤ 6 L/min)

Experimental: Pressure-Support trial
In patients assigned to experimental group all spontaneous breathing trials will be performed with a pressure-support level of 8 cm H2O without positive end-expiratory pressure.
Procedure: Pressure-support trial
Pressure-Support trial will be performed for around 1 hour without disconnecting the patient from the ventilator, by using a low level of pressure-support (PS 8 cm H2O) with a FiO2 ≤ 40% and without positive end-expiratory pressure (PEEP), while continuously monitoring the respiratory rate and tidal volume on the ventilator display.




Primary Outcome Measures :
  1. Number of ventilator-free days at day 28 [ Time Frame: Day 28 ]
    The number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation (intubation or tracheostomy) between the first spontaneous breathing trial (day 1) and day 28.


Secondary Outcome Measures :
  1. The number of days alive and without mechanical ventilation (including intubation or non-invasive ventilation) between the first spontaneous breathing trial (day 1) and day 28. [ Time Frame: Between Day 1 and Day 28 ]
  2. The number of patients extubated within the 72 hours and within the 7 days following the first spontaneous breathing trial. [ Time Frame: Hour 72, Day 7 ]
  3. The number of patients extubated after simple (24h), difficult (> 24 hours and ≤ 7 days) or prolonged ( > 7 days) weaning [ Time Frame: Day 28 ]
  4. The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours. [ Time Frame: Hour 72 ]
  5. The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients [ Time Frame: Day 28 ]
  6. The number of patients reintubated within the 72 hours and within the 7 days following extubation. [ Time Frame: Day 28 ]
  7. The number of patients with post-extubation respiratory failure within the 7 days following extubation. [ Time Frame: Day 28 ]
  8. Length of stay in ICU in days. [ Time Frame: Day 90 ]
  9. Numbers of patients died in ICU, at day 28 and at day 90. [ Time Frame: Day 28 and Day 90 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Duration of mechanical ventilation prior to the first spontaneous brathing trial > 24h
  2. Patients at high-risk of reintubation according to the following criteria: Patients older than 65 years, or those having any underlying chronic cardiac or lung disease.
  3. Patient meeting all weaning criteria according to the international conference consensus on weaning.

    • Respiratory rate ≤ 35 breaths per minute,
    • Adequate oxygenation defined as SpO2 > 90% with FiO2 ≤ 0.4 or PaO2/FiO2 > 150 mm Hg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,
    • Adequate cough,
    • Patient awake with a Richmond Agitation-Sedation Scale between +1 and -2
    • No continuous sedation,
    • Hemodynamic stability with no need for vasopressors (or minimal dosis).
  4. Informed consent given by the relatives or the patient himself.

Exclusion Criteria:

  1. Patients admitted for traumatic brain injury
  2. Pre-existing peripheral neuromuscular disease (underlying myopathy or myasthenia gravis)
  3. Do-not-reintubate order at time of the first spontaneous breathing trial
  4. Patient previously included in the study
  5. No Health insurance coverage
  6. People under protection: Pregnant or breastfeeding women, minor patients, subjects with guardianship or under law protection.
  7. Refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227639


Contacts
Layout table for location contacts
Contact: Arnaud W. THILLE, Pr 0549446064 ext +33 arnaud.thille@chu-poitiers.fr
Contact: Céline DELETAGE 0549443854 celine.deletage@chu-poitiers.fr

Locations
Layout table for location information
France
Intensive reanimation
Poitiers, France, 86000
Sponsors and Collaborators
Poitiers University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Arnaud W. THILLE, Pr CHU Poitiers

Layout table for additonal information
Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT04227639    
Other Study ID Numbers: TiP-Ex
2019-A02151-56 ( Other Identifier: ID-RCB )
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes