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Does Tracheal Suction During Extubation in Intensive Care Unit Decrease Functional Residual Capacity

Primary Purpose

Critically Ill, Extubation, Intensive Care Unit

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
no tracheal suction
tracheal suction
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critically Ill focused on measuring critically ill patient, extubation, tracheal suction, intensive care unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age of 18 years or more
  • hospitalization in the surgical ICU (whatever the cause of hospitalization)
  • under mechanical ventilation via a tracheal tube (oro or nasotracheal) for at least 24 hours
  • satisfying general criteria for mechanical ventilation weaning (described by the French Language Resuscitation Society)
  • having successfully completed a spontaneous breathing trial (among those described by the SRLF)
  • physiotherapist available during the first hour after extubation

Exclusion Criteria:

  • the presence of an electrical implantable medical device (pacemaker, automatic defibrillator, deep brain stimulation box)
  • body mass index (BMI) > 50
  • pregnancy
  • tracheal tube with subglottic suction channel
  • technical impossibility of monitoring by electrical impedance tomography (chest plaster, undrained pneumothorax, ...).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    tracheal suction

    no tracheal suction

    Arm Description

    After a standardized protocol during the thirty minutes before extubation, extubation was performed with a standardized tracheal suction.

    After a standardized protocol during the thirty minutes before extubation, extubation was performed without tracheal suction.

    Outcomes

    Primary Outcome Measures

    ΔEELI 15
    The primary endpoint was the end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 15 minutes after extubation (ΔEELI 15). It happened so 45 minutes after inclusion (30 minutes of extubation protocol and 15 minutes after extubation)

    Secondary Outcome Measures

    ΔEELI H1
    The end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 60 minutes after extubation
    ΔEELI H2
    The end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 120 minutes after extubation
    Lowest oxygen saturation by pulse oximetry
    The lowest oxygen saturation by pulse oximetry observed within 6 hours after extubation
    Oxygen flow
    The maximum oxygen flow administered within 6 hours after extubation (for oxygen saturation by pulse oximetry between 95 and 98%)
    arterial partial pressure of oxygen
    Variation of arterial partial pressure of oxygen within 6 hours after extubation (1 arterial blood gas analysis before extubation and 2 after)
    arterial oxygen saturation
    Variation of arterial oxygen saturation within 6 hours after extubation (1 arterial blood gas analysis before extubation and 2 after)
    arterial partial pressure of carbon dioxide
    Variation of arterial partial pressure of carbon dioxide within 6 hours after extubation (1 arterial blood gas analysis before extubation and 2 after)
    Respiratory rates
    Respiratory rates 1 hour and then, 6 hours after the extubation
    Respiratory complication
    Composite endpoint including the occurence of at least of of the following complication during 48 hours after extubation: failure of extubation (need for reintubation) new atelectasis after extubation (a chest x-ray was supposed to support the diagnosis) the use of non-invasive ventilation for acute respiratory distress new pneumonia after extubation
    Death
    The occurence of death of the patient during 48 hours after extubation (whatever the cause of death was)

    Full Information

    First Posted
    March 6, 2018
    Last Updated
    September 20, 2018
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03681626
    Brief Title
    Does Tracheal Suction During Extubation in Intensive Care Unit Decrease Functional Residual Capacity
    Official Title
    Does Tracheal Suction During Extubation in Intensive Care Unit Decrease Functional Residual Capacity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 27, 2015 (Actual)
    Primary Completion Date
    August 31, 2016 (Actual)
    Study Completion Date
    September 2, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    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
    Little is known about the procedure of extubation of patients admitted in Intensive Care Units (ICU). In particular, effects of tracheal suction during extubation have never been evaluated. Tracheal suction induces alveolar derecruitment in sedated patients under mechanical ventilation and is a major source of pain. The aim of this study was to evaluate the impact of tracheal suction during the extubation procedure of critically ill patients on the end-expiratory lung volume.
    Detailed Description
    This is a prospective, monocentric study, conducted in the surgical ICU of the university hospital of Rouen, France. Sixty patients were expected to be randomized before extubation into two groups (ratio of 1:1) with different extubation protocols depending on whether tracheal suction was performed or not. After oral information and collection of the non opposition of the patient to participate in the study, eligible patients were randomized (raio 1:1) in two groups: "tracheal suction" group or "no tracheal suction" group. The allocation concealment was assured by enclosing assignments in sequentially numbered, opaque, sealed envelopes. Envelopes were opened after enrolment of each patient by the medical doctor in charged. Each envelope contained a number by a random allocation process using a computer-generated random block design (the randomization list was established by the local biostatistics unit before the beginning of the study). Juste after inclusion, the 30 minutes standardized extubation protocol started and consisted of: arterial blood gas analysis before the extubation (if there wasn't one dating less than 6 hours), adjustment of the backrest of the bed in tilt to + 45 °, tracheal suction 30 minutes before extubation (using a 14 french catheter, a vacuum of -200 mmHg systematically measured by a manometer XX), the ventilator was then set on pressure support ventilation with pressure support level of 8 cmH2O and positive end-expiratory pressure (PEEP) of 5 cmH2O (FiO2 was adjusted for oxygen saturation by pulse oximetry between 95 and 98%) for 30 minutes, installation of electrode belt for electrical impedance tomography (EIT) monitoring (Pulmovista 500, Dräger®) and calibration of the system, aspiration of oropharyngeal secretions immediately before extubation with an oral cannula. for "tracheal suction" group, extubation occured 30 minutes after inclusion. A tracheal suction (using a 14 french catheter, a vacuum of -200 mmHg) was performed at the same time as removal of the tracheal tube, after disconnection of the ventilator and after deflating the balloon of the tracheal tube. for "no tracheal suction" group, extubation occured 30 minutes after inclusion and was performed after deflation of the balloon (and without further maneuver). all patients underwent chest physical therapy between the 15th and 60th minutes following extubation. No calculation of the number of subjects needed was possible (no data available concerning ΔEELI at extubation). Data were described in the whole population and for each group ("tracheal suction" and "no tracheal suction") using the usual descriptive parameters: frequency for qualitative variables, median and interquartile range (IQR) for quantitative variables. Statistical analysis consisted of a nonparametric Mann and Whitney test for the quantitative variables and an exact Fisher test for the qualitative variables (using Statistical Analysis System software, version 9.4, Statistical Analysis System Institute; Cary, NC). The significance of the tests was retained for an α risk of 5%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critically Ill, Extubation, Intensive Care Unit
    Keywords
    critically ill patient, extubation, tracheal suction, intensive care unit

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tracheal suction
    Arm Type
    Active Comparator
    Arm Description
    After a standardized protocol during the thirty minutes before extubation, extubation was performed with a standardized tracheal suction.
    Arm Title
    no tracheal suction
    Arm Type
    Experimental
    Arm Description
    After a standardized protocol during the thirty minutes before extubation, extubation was performed without tracheal suction.
    Intervention Type
    Procedure
    Intervention Name(s)
    no tracheal suction
    Intervention Description
    No tracheal suctioning during extubation
    Intervention Type
    Procedure
    Intervention Name(s)
    tracheal suction
    Intervention Description
    tracheal suctioning during extubation
    Primary Outcome Measure Information:
    Title
    ΔEELI 15
    Description
    The primary endpoint was the end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 15 minutes after extubation (ΔEELI 15). It happened so 45 minutes after inclusion (30 minutes of extubation protocol and 15 minutes after extubation)
    Time Frame
    15 minutes after extubation
    Secondary Outcome Measure Information:
    Title
    ΔEELI H1
    Description
    The end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 60 minutes after extubation
    Time Frame
    60 minutes after extubation
    Title
    ΔEELI H2
    Description
    The end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 120 minutes after extubation
    Time Frame
    120 minutes after extubation
    Title
    Lowest oxygen saturation by pulse oximetry
    Description
    The lowest oxygen saturation by pulse oximetry observed within 6 hours after extubation
    Time Frame
    360 minutes after extubation
    Title
    Oxygen flow
    Description
    The maximum oxygen flow administered within 6 hours after extubation (for oxygen saturation by pulse oximetry between 95 and 98%)
    Time Frame
    360 minutes after extubation
    Title
    arterial partial pressure of oxygen
    Description
    Variation of arterial partial pressure of oxygen within 6 hours after extubation (1 arterial blood gas analysis before extubation and 2 after)
    Time Frame
    360 minutes after extubation
    Title
    arterial oxygen saturation
    Description
    Variation of arterial oxygen saturation within 6 hours after extubation (1 arterial blood gas analysis before extubation and 2 after)
    Time Frame
    360 minutes after extubation
    Title
    arterial partial pressure of carbon dioxide
    Description
    Variation of arterial partial pressure of carbon dioxide within 6 hours after extubation (1 arterial blood gas analysis before extubation and 2 after)
    Time Frame
    360 minutes after extubation
    Title
    Respiratory rates
    Description
    Respiratory rates 1 hour and then, 6 hours after the extubation
    Time Frame
    360 minutes after extubation
    Title
    Respiratory complication
    Description
    Composite endpoint including the occurence of at least of of the following complication during 48 hours after extubation: failure of extubation (need for reintubation) new atelectasis after extubation (a chest x-ray was supposed to support the diagnosis) the use of non-invasive ventilation for acute respiratory distress new pneumonia after extubation
    Time Frame
    48 hours after extubation
    Title
    Death
    Description
    The occurence of death of the patient during 48 hours after extubation (whatever the cause of death was)
    Time Frame
    48 hours after extubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age of 18 years or more hospitalization in the surgical ICU (whatever the cause of hospitalization) under mechanical ventilation via a tracheal tube (oro or nasotracheal) for at least 24 hours satisfying general criteria for mechanical ventilation weaning (described by the French Language Resuscitation Society) having successfully completed a spontaneous breathing trial (among those described by the SRLF) physiotherapist available during the first hour after extubation Exclusion Criteria: the presence of an electrical implantable medical device (pacemaker, automatic defibrillator, deep brain stimulation box) body mass index (BMI) > 50 pregnancy tracheal tube with subglottic suction channel technical impossibility of monitoring by electrical impedance tomography (chest plaster, undrained pneumothorax, ...).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Benoît VEBER, MD, PhD
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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