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.

NCT03689309 | Completed

• 1 other identifier: CHRO-2018-06
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Mechanical Ventilator Weaning; Endotracheal Extubation

Keywords

Spontaneous breathing Trial; High Flow Oxygen

Outcome Measures

Primary Outcomes (2)

• Actuarial rate of extubation

  This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 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 This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 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

  Day 7

• Reintubation Rate

  This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 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

  Day 7

Secondary Outcomes (3)

• Success rate of the first SBT

  Day 0

• Ventilator free-days

  Day 28

• Rate of Ventilator Associated Pneumonia

  Day 7

Study Arms (2)

1. Classic SBT (C-SBT)

NO INTERVENTION

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.

2. High Flow Oxygen SBT (HFO-SBT)

EXPERIMENTAL

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.

Procedure: High Flow Oxygen SBT

Interventions

High Flow Oxygen SBT 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.

2. High Flow Oxygen SBT (HFO-SBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orleans

Orléans, 45067, France

Location

Related Publications (3)

• 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.

  PMID: 23641924 BACKGROUND

• 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.

  PMID: 24865303 BACKGROUND

• 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.

  PMID: 7921460 BACKGROUND

Study Officials

• Mai-Anh NAY, Dr

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: September 28, 2018
• Study Start: October 16, 2018
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)