High Flow Oxygen During Spontaneous Breathing Trial in Patients With High Weaning Risk Failure: Impact on the Weaning Course at D7 From the First Spontaneous Breathing Trial.

NCT ID: NCT03689309

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2020-07-15

Brief Summary

In intensive care unit (ICU), mechanical ventilation (MV) is part of routine care.

Weaning phase is a daily preoccupation for the caregivers. Prolonged MV can lead to many complications. Failing the weaning phase expose the patient to the need for reintubation, that improves the mortality.

The caregiver faces a major problem, in one hand the need to wean properly and quickly and on the other the risk of reintubation.

In order to help the clinician making the good choice, the spontaneous breathing trial (SBT) is a key tool. The international literature provides the investigators many ways to perform the SBT. The most common is the T-piece; the patient is disconnected from the ventilator and connected to a T-piece that can provide supplemental oxygen. Another one is the Support pressure trial, the patient is still connected to the ventilator, but the setups are changed to recreate the T-piece conditions.

In many French ICU's, the SBT is performed by using a heat humidifier filter that is directly connected to the endotracheal tube, this filter allows the clinician to provide supplemental oxygen in accordance with the patient need.

In high risk for reintubation patients, the SBT can create physical stress, that lead to prolonged MV.

In our ICU, for those patients, the investigators perform the SBT by connecting the patient to a device that provides high flow oxygen trough endotracheal connector for tracheotomy.

The investigators hypothesis that high flow oxygen SBT, will allow the high risk for reintubation patients to succeed the SBT.

Detailed Description

The investigators proposed to compare 2 strategies for SBT in high risk for reintubation patients:

1. Classic SBT (C-SBT)

2. High Flow Oxygen SBT (HFO-SBT)

This prospective randomized study had 2 conjoint primary outcome:

1. The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase

2. Compare the reintubation rate at D7 from the extubation

Conditions

Mechanical Ventilation; Mechanical Ventilator Weaning; Endotracheal Extubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1. Classic SBT (C-SBT)

The patient is disconnected from the ventilator and remains 30 minutes without support but oxygen delivered through a heat humidifier filter that is usually connected on tracheotomy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2. High Flow Oxygen SBT (HFO-SBT)

The patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy.

Group Type: EXPERIMENTAL

High Flow Oxygen SBT

Intervention Type: PROCEDURE

The patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy.

Interventions

High Flow Oxygen SBT

The patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age > 18 yrs.
• Admission in ICU
• Mechanically ventilated > 24 hours
• Mechanically ventilated using support ventilation mode
• Patient with one of these criterion:

• Cardiac disease (left ventricular dysfunction LVEF <46%, antecedent of ischemic heart disease, antecedent of acute pulmonary edema)
• Respiratory disease (COPD, Emphysema, bronchectiasis, asthma, obesity-hypoventilation syndrome, restrictive pulmonary disease)
• Informed and signed consent from the patient or next of kin.

Exclusion Criteria

• Head trauma as a cause for ICU admission
• Neuromuscular disease prior ICU admission
• Tracheotomized patient
• Pregnancy
• Decision not to forgo life sustaining therapy
• Patient not affiliated with a social security organism
• Adult private from his liberty with judicial decision
• Patient that have already been included in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mai-Anh NAY, Dr

Role: PRINCIPAL_INVESTIGATOR

CHR d'Orléans

Locations

CHR d'Orleans

Orléans, , France

Countries

France

References

Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.

Reference Type: BACKGROUND

PMID: 23641924 (View on PubMed)

Ladeira MT, Vital FM, Andriolo RB, Andriolo BN, Atallah AN, Peccin MS. Pressure support versus T-tube for weaning from mechanical ventilation in adults. Cochrane Database Syst Rev. 2014 May 27;2014(5):CD006056. doi: 10.1002/14651858.CD006056.pub2.

Reference Type: BACKGROUND

PMID: 24865303 (View on PubMed)

Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.

Reference Type: BACKGROUND

PMID: 7921460 (View on PubMed)

Other Identifiers

CHRO-2018-06

Identifier Type: -

Identifier Source: org_study_id