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
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
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
NCT ID
NCT03681626
First Posted
March 6, 2018
Last Updated
September 20, 2018
Sponsor
University Hospital, Rouen
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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Does Tracheal Suction During Extubation in Intensive Care Unit Decrease Functional Residual Capacity
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