Mechanical Ventilation Clinical Trial
— ObiWEANOfficial title:
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. A Pilot Randomized Controlled Trial
Verified date | July 2020 |
Source | Centre Hospitalier Régional d'Orléans |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | July 15, 2020 |
Est. primary completion date | July 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHR d'Orleans | Orléans |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional d'Orléans |
France,
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. — View Citation
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;(5):CD006056. doi: 10.1002/14651858.CD006056.pub2. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Actuarial rate of extubation | This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase 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: The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase Compare the reintubation rate at D7 from the extubation |
Day 7 | |
Primary | Reintubation Rate | This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase Compare the reintubation rate at D7 from the extubation |
Day 7 | |
Secondary | Success rate of the first SBT | Success rate of the first SBT will be compared between the two groups. | Day 0 | |
Secondary | Ventilator free-days | Ventilator free-days at day 28 from the admission in ICU | Day 28 | |
Secondary | Rate of Ventilator Associated Pneumonia | Rate of Ventilator Associated Pneumonia at day 7 from the extubation | Day 7 |
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