An observational study in Critically Ill, Extubation and Intensive Care Unit, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by University Hospital, Rouen · Observational
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.
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:
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%.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 60 is below the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
After a standardized protocol during the thirty minutes before extubation, extubation was performed with a standardized tracheal suction.
Procedure: tracheal suction
After a standardized protocol during the thirty minutes before extubation, extubation was performed without tracheal suction.
Procedure: no tracheal suction
No tracheal suctioning during extubation
tracheal suctioning during extubation
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)
Time frame: 15 minutes after extubation
ΔEELI H1
The end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 60 minutes after extubation
Time frame: 60 minutes after extubation
ΔEELI H2
The end-expiratory lung impedance variation (ΔEELI) between immediately before extubation and 120 minutes after extubation
Time frame: 120 minutes after extubation
Lowest oxygen saturation by pulse oximetry
The lowest oxygen saturation by pulse oximetry observed within 6 hours after extubation
Time frame: 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%)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 360 minutes after extubation
Respiratory rates
Respiratory rates 1 hour and then, 6 hours after the extubation
Time frame: 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
Time frame: 48 hours after extubation
Death
The occurence of death of the patient during 48 hours after extubation (whatever the cause of death was)
Time frame: 48 hours after extubation
Plan to share: No
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University Hospital, Rouen