Long Term Outcome on Brain and Lung of Different Oxygen Strategies in ARDS Patients

NCT03621293 | Unknown Phase 3 DMC

• 1 other identifier: N/2016/74
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

Acute respiratory distress syndrome (ARDS) is a serious disease with high mortality. In patients who survive ARDS, respiratory, neurological and motor sequelae are frequent, negatively impacting on the patient's quality of life, and engendering substantial healthcare costs (rehabilitation, long-term care, delayed return to work). There may also be repercussions on the patient's family and entourage. The severity of ARDS and the burden it represents have underpinned intensive research to identify treatment strategies that could improve mortality. However, it is important to ensure that any improvement in mortality does not come at the price of an excess of sequelae and disability in survivors. The oxygenation strategy used to treat ARDS may have an impact on mortality in these patients. The CLOSE study, in which our group participated, recently demonstrated the feasibility of two oxygenation strategies in intensive care unit (ICU) patients with ARDS. We have also initiated the LOCO-2 study (NCT02713451), whose aim is to show a reduction in mortality in ARDS using a "conservative" oxygenation strategy (PaO2 maintained between 55 and 70 mmHg) as compared to a classical "liberal" oxygenation strategy (PaO2 between 90 and 105 mmHg). The LTO-BLOXY study is a substudy of the on-going LOCO-2 study

Conditions

Acute Respiratory Distress Syndrome

Keywords

Long term outcome; Brain; Lung; Oxygen strategies

Outcome Measures

Primary Outcomes (1)

• Diffusing Capacity of the Lungs for carbon monoxide (DLCO)

  The primary endpoint is the diffusing capacity of the lungs for carbon monoxide (DLCO), a measure that reflects disorders in pulmonary gas volume, the alveolar-capillary membrane, and the volume of blood in the lung capillaries

  6 months

Secondary Outcomes (11)

• Evaluation of disability (Functional Independence Measure)

  inclusion, 6 months

• A binary composite morbi-mortality variable

  6 months, 12 months

• Respiratory function: plethysmography

  3 months, 6 months, 12 months

• Respiratory function

  3 months, 6 months, 12 months

• Respiratory function: blood gases

  3 months, 6 months, 12 months

Study Arms (2)

Liberal Oxygenation (LO) group

ACTIVE COMPARATOR

A modulation of inspired fraction of oxygen will be performed with an objective of PaO2 between 90 to 105 mmHg that will be checked on arterial blood gases (ABG). Between these measurements, SpO2 will be kept more or equal to 96 percent. Alarms will be set at 95 percent for SpO2. Intervention: Drug: Modulation of Inspired Fraction of Oxygen (FiO2)

Drug: Modulation of Inspired Fraction of Oxygen (FiO2)

Conservative Oxygenation (CO) group

EXPERIMENTAL

A modulation of inspired fraction of oxygen will be performed with an objective of PaO2 between 55 to 70 mmHg that will be checked on arterial blood gases. Between these measurements, SpO2 will be kept between 88 and 92 percent. Alarms will be set between 87 and 93 percent for SpO2. Intervention: Drug: Modulation of Inspired Fraction of Oxygen (FiO2)

Drug: Modulation of Inspired Fraction of Oxygen (FiO2)

Interventions

Modulation of Inspired Fraction of Oxygen (FiO2) DRUG

In the two groups, if patient is not in the range of arterial oxygen pressure (PaO2), Inspired Fraction of Oxygen (FiO2) will be modified from 5 percent if difference between target is less than 5 mmHg and from 10 percent if difference from target is higher. A new arterial blood gases (ABG) will be performed 30 minutes later to check for the oxygen target range. When ABG are performed, pulsed oxymetry is compared with arterial saturation (SaO2) to adapt survey. Between each ABG, FiO2 is modified from 5 percent to 5 percent each five minutes until reaching good pulsed oxygen saturation (SpO2) target (that can be modified in function of the comparison of arterial oxygen saturation (SaO2 and SpO2 with ABG). This management of FiO2 will be done until extubation of the patient.

Conservative Oxygenation (CO) group; Liberal Oxygenation (LO) group

Eligibility Criteria

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

You may qualify if:

• ARDS defined as a PF ratio \<300
• Patients under ventilation for \<12 hours
• Stabilization period of 3 hours with standardization of ventilation parameters
• \- Patient aged between 20 and 89 years

You may not qualify if:

• Chronic respiratory failure or on home ventilation (excluding obstructive sleep apnoea)
• Cardiac arrest
• Moribund patients (death likely within 48 hours as assessed by the ICU physician)
• Gaseous embolism
• CO poisoning
• Pregnant women
• Indication for hyperbaric oxygen treatment
• Persistent pneumothorax
• Gaseous gangrene
• DNR or limited care order
• History of neurological disorders: cranial trauma, stroke, cerebral tumor, epilepsy, neuro-degenerative disease.
• Psychiatric disorders: bipolar disorder, psychosis, addiction, schizophrenia.
• Lack of autonomy due to previously documented cognitive and/or psychomotor impairment.
• Hearing and/or sight impairment that prevent the patient from performing the study tests

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Bruno DEGANO, MD

CONTACT

3 81 21 87 45; bruno.degano@univ-fcomte.fr

Sophie DEPIERRE

CONTACT

3 81 21 87 45; sdepierre@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 8, 2018
• Study Start: September 20, 2017
• Primary Completion: March 20, 2021
• Study Completion: September 20, 2021
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

FR (1)