NCT03681626

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

March 6, 2018

Last Update Submit

September 20, 2018

Conditions

Keywords

critically ill patientextubationtracheal suctionintensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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)

    15 minutes after extubation

Secondary Outcomes (10)

  • ΔEELI H1

    60 minutes after extubation

  • ΔEELI H2

    120 minutes after extubation

  • Lowest oxygen saturation by pulse oximetry

    360 minutes after extubation

  • Oxygen flow

    360 minutes after extubation

  • arterial partial pressure of oxygen

    360 minutes after extubation

  • +5 more secondary outcomes

Study Arms (2)

tracheal suction

ACTIVE COMPARATOR

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

Procedure: tracheal suction

no tracheal suction

EXPERIMENTAL

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

Procedure: no tracheal suction

Interventions

No tracheal suctioning during extubation

no tracheal suction

tracheal suctioning during extubation

tracheal suction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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, ...).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Benoît VEBER, MD, PhD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2018

First Posted

September 24, 2018

Study Start

October 27, 2015

Primary Completion

August 31, 2016

Study Completion

September 2, 2016

Last Updated

September 24, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share