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

NCT ID: NCT03681626

Last Updated: 2018-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-27

Study Completion Date

2016-09-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Critically Ill Extubation Intensive Care Unit

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

tracheal suction

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

Group Type ACTIVE_COMPARATOR

tracheal suction

Intervention Type PROCEDURE

tracheal suctioning during extubation

no tracheal suction

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

Group Type EXPERIMENTAL

no tracheal suction

Intervention Type PROCEDURE

No tracheal suctioning during extubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no tracheal suction

No tracheal suctioning during extubation

Intervention Type PROCEDURE

tracheal suction

tracheal suctioning during extubation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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, ...).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benoît VEBER, MD, PhD

Role: STUDY_CHAIR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-A00846-43

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.