Postoperative Extubation in Hypoxemic Patients (EPHYRE)

Fondation Hôpital Saint-Joseph

Status: Not yet enrolling

Conditions: Postoperative Respiratory Complication; Extubation; Hypoxemia

Treatments: Other: early extubation of hypoxemic patients

Study type: Interventional

Funder types: Other

Identifiers

NCT06688487

2024-A00535-42

Details and patient eligibility

About

The objective of this clinical trial is to assess whether early extubation of patients with hypoxemia during the spontaneous breathing trial (SBT) shortens the duration of ventilatory support. The trial will also evaluate the safety of this approach. The key research questions include:

Does early extubation of hypoxemic patients reduce the total duration of ventilatory support (both invasive and non-invasive) by 36 hours? Does early extubation of hypoxemic patients increase the number of ventilator-free days by day 28? Can the safety of early extubation in hypoxemic patients be ensured by confirming no significant differences in rates of reintubation, tracheostomy, or mortality? The trial will compare ventilatory outcomes between two groups: hypoxemic patients who undergo early extubation (hypoxemic extubation group) and those who remain on invasive ventilation until hypoxemia resolves (conventional extubation group).

Full description

International guidelines recommend extubating patients after correction of hypoxemia, meaning if the SpO2 measured during the spontaneous breathing trial is above 92%. However, there is strong rationale for modifying this practice to extubate patients earlier, particularly those presenting with hypoxemia after major surgery, by using alternating non-invasive ventilation (NIV) and high-flow oxygen therapy:

Several studies have found no link between patient oxygenation and extubation success, where outcomes for hypoxemic and non-hypoxemic patients are similar. Isolated hypoxemia thus does not appear to be a predictor of reintubation.

Hypoxemia is very common following major surgery, primarily due to shunts caused by atelectasis. Treatment for these atelectasis includes airway pressurization, bronchial secretion drainage, mobilization, and reducing factors that lead to diaphragmatic dysfunction.

In patients on invasive mechanical ventilation, secretion drainage is impaired, and mobilization to a seated position is more challenging. It has also been shown that diaphragmatic dysfunction occurs with prolonged ventilation. Hypoxemia can therefore be sustained by invasive ventilation, increasing the risk of therapeutic escalation.

Current guidelines do not account for the widespread use of non-invasive assistance techniques (such as high-flow oxygen therapy and non-invasive ventilation) that are now routinely employed in intensive care. These techniques allow for adequate oxygenation with high patient comfort and good tolerance.

Prolonging invasive ventilation in hypoxemic patients, as recommended by guidelines, could lead to associated complications. In contrast, early extubation of patients with hypoxemia may reduce the duration of both invasive and non-invasive ventilation, as well as complications related to prolonged invasive ventilation, without increasing the risk of reintubation.

Compared to continuing mechanical ventilation until hypoxemia is corrected, extubating purely hypoxemic patients and transitioning them to non-invasive ventilation techniques could represent a significant improvement in patient care.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Francophone patient affiliated to a health insurance plan;
• Patient having granted free, informed and written consent to participate in the study;
• Patient with hypoxemia defined as SpO2 ≤ 90% under 6 L/min or FiO2 40% during spontaneous breathing trial.

Exclusion criteria

• Presence of hypercapnia at the end of SBT (PaCO2 above 50 mmHg);
• Presence of severe hypoxemia during SBT defined by SpO2 below 86% under 9 L/min or FiO2 = 50%;
• Presence of poor clinical tolerance of SBT defined by polypnoea above 30/min, agitation, sweating, hypertension (PAS above 180 mmHg), tachycardia (HR above 140 bpm) or arrhythmia;
• Presence of an ineffective cough or major bronchial congestion;
• Patient already included in a type 1 interventional research protocol (RIPH1), modifying the procedure for ventilatory weaning and/or ventilatory support after extubation;
• Anatomical factors precluding the use of NIV or high-flow oxygen therapy, notably facial or cervico-facial malformations;
• Tracheostomized patient;
• History of obstructive ventilatory disorders with indication for NIV post-extubation, chronic obstructive pulmonary disease (COPD) GOLD score III/IV;
• History of obstructive sleep apnea syndrome with equipment;
• cardiogenic pulmonary edema;
• Patient on extracorporeal membrane oxygenation (ECMO) at the time of inclusion;
• Patient under guardianship or curatorship;
• Minor patients;
• Patient deprived of liberty or under court protection;
• Pregnant or breast-feeding women;
• Patient in therapeutic limitation with decision not to re-intubate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

hypoxemic extubation group

Experimental group

Description:

Randomized patients exhibit relative hypoxemia, defined by an SpO2 ≤ 90% while receiving 6 liters of oxygen or FiO2 of 40%. They must not have severe hypoxemia, defined as an SpO2 \< 86% while receiving 9 liters of oxygen or FiO2 of 50%. Additionally, they must not show clinical signs of poor tolerance to the spontaneous breathing trial. Patients randomized to the "hypoxemic extubation group" are extubated despite the presence of relative hypoxemia after one hour of reventilation. Following extubation, a non-invasive oxygenation strategy is initiated, alternating between non-invasive ventilation and high-flow oxygen therapy for a minimum of 24 hours.

Treatment:

Other: early extubation of hypoxemic patients

conventional extubation group

No Intervention group

Description:

Patients in the conventional extubation group also present with relative hypoxemia, defined as an SpO2 ≤ 90% on 6 liters of oxygen or FiO2 of 40% at the time of randomization, but they will only be extubated after correction of this hypoxemia. In practice, patients in the conventional extubation group are not extubated after randomization and continue on invasive ventilation. A new spontaneous breathing trial (SBT) can be performed between 2 and 6 hours after randomization, and if unsuccessful, it may be repeated daily at the discretion of the clinician. Patients in the conventional extubation group will only be extubated when their SpO2 exceeds 90% during an SBT conducted on 6 liters of oxygen or FiO2 of 40%. After extubation, a non-invasive oxygenation strategy will be initiated, alternating between non-invasive ventilation (NIV) and high-flow oxygen therapy, for a minimum of 24 hours.