Critically IllNCT03681626
Does Tracheal Suction During Extubation in Intensive Care Unit Decrease Functional Residual Capacity
An observational study of Critically Ill and Extubation, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critically Ill, Extubation, Intensive Care Unit
- What is being tested?
- no tracheal suction and tracheal suction
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2015to 2 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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, ...).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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%.
- Conditions
- Critically Ill, Extubation, Intensive Care Unit
- Being tested
- no tracheal suction, tracheal suction
- Keywords
- critically ill patient, extubation, tracheal suction, intensive care unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no tracheal suctionProcedure or surgery
No tracheal suctioning during extubation
tracheal suctionProcedure or surgery
tracheal suctioning during extubation
| Study group | Role | What they receive |
|---|---|---|
| tracheal suction | After a standardized protocol during the thirty minutes before extubation, extubation was performed with a standardized tracheal suction. Receives: Procedure: tracheal suction | |
| no tracheal suction | After a standardized protocol during the thirty minutes before extubation, extubation was performed without tracheal suction. Receives: Procedure: no tracheal suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 15 minutes after extubation
Secondary outcomes (10)
ΔEELI H1
The end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 60 minutes after extubation
Measured: 60 minutes after extubation
ΔEELI H2
The end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 120 minutes after extubation
Measured: 120 minutes after extubation
Lowest oxygen saturation by pulse oximetry
The lowest oxygen saturation by pulse oximetry observed within 6 hours after extubation
Measured: 360 minutes after extubation
Oxygen flow
The maximum oxygen flow administered within 6 hours after extubation (for oxygen saturation by pulse oximetry between 95 and 98%)
Measured: 360 minutes after extubation
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)
Measured: 360 minutes after extubation
arterial oxygen saturation
Variation of arterial oxygen saturation within 6 hours after extubation (1 arterial blood gas analysis before extubation and 2 after)
Measured: 360 minutes after extubation
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)
Measured: 360 minutes after extubation
Respiratory rates
Respiratory rates 1 hour and then, 6 hours after the extubation
Measured: 360 minutes after 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
Measured: 48 hours after extubation
Death
The occurence of death of the patient during 48 hours after extubation (whatever the cause of death was)
Measured: 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start27 Oct 2015
- Primary completion31 Aug 2016
- Study completion2 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît VEBER, MD, PhD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681626
- Sponsor's protocol ID
- 2015-A00846-43
- Status last verified
- Sep 2018
- First submitted
- 6 Mar 2018
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Tracheal Suction During Extubation in Intensive Care Unit Decrease Functional Residual Capacity
- ClinicalTrials.gov ID
- NCT03681626
- Acronym / sponsor ID
- 2015-A00846-43
- Conditions
- Critically Ill, Extubation, Intensive Care Unit
- Keywords
- critically ill patient, extubation, tracheal suction, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 2 Sep 2016 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tracheal suction | – | Procedure: tracheal suctionAfter a standardized protocol during the thirty minutes before extubation, extubation was performed with a standardized tracheal suction. |
| no tracheal suction | – | Procedure: no tracheal suctionAfter a standardized protocol during the thirty minutes before extubation, extubation was performed without tracheal suction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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, ...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no tracheal suctionNo tracheal suctioning during extubation | Procedure or surgery | no tracheal suction |
| tracheal suctiontracheal suctioning during extubation | Procedure or surgery | tracheal suction |
Primary outcome
ΔEELI 15
Time frame: 15 minutes after extubation
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)
10 secondary outcomes
ΔEELI H1
Time frame: 60 minutes after extubation
ΔEELI H2
Time frame: 120 minutes after extubation
Lowest oxygen saturation by pulse oximetry
Time frame: 360 minutes after extubation
Oxygen flow
Time frame: 360 minutes after extubation
arterial partial pressure of oxygen
Time frame: 360 minutes after extubation
arterial oxygen saturation
Time frame: 360 minutes after extubation
arterial partial pressure of carbon dioxide
Time frame: 360 minutes after extubation
Respiratory rates
Time frame: 360 minutes after extubation
Respiratory complication
Time frame: 48 hours after extubation
Death
Time frame: 48 hours after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Critically Ill
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
RecruitingObservational study
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Critically-ill Patients
Not yet recruitingPhase 3
Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients
Long-term Sedation for Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
RecruitingObservational study
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Cardiac Disease, Critically Ill
Active, not recruitingPhase 3
Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
The Critically Ill Patient is Requiring Intubation, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît VEBER, MD, PhD study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Extubation, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔEELI 15 (time frame: 15 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.