Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Outcome on Brain and Lung of Different Oxygen Strategies in ARDS Patients (LTO-BLOXY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03621293
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: Modulation of Inspired Fraction of Oxygen (FiO2) Phase 3

Detailed Description:

The LTO-BLOXY study will compare respiratory, cognitive and exercise function outcomes in patients who underwent one of the two oxygenation strategies in the context of the on-going LOCO-2 study:

  • Experimental group: oxygenation will be maintained at a level between 55 and 70 mmHg of PaO2 as measured by blood gas test ("conservative" oxygenation). Between blood gas measures, oxygenation will be optimized to achieve an SpO2 between 88% and 92%.
  • Control group: oxygenation will be maintained at a level between 90 and 105 mmHg of PaO2 as measured by blood gas test ("liberal" oxygenation). Between blood gas measures, oxygenation will be optimized to achieve an SpO2 >96%.

The primary objective is to demonstrate a lower level of impairment of respiratory function at 6 months in survivors of acute respiratory distress syndrome (ARDS) after a "conservative" oxygenation strategy, as compared to a "liberal" oxygenation strategy.

Secondary objectives are numerous and will explore different areas such as evalution of disability, respiratory function, exercise function, cognitive function and quality of life.

Participation in the LTO-BLOXY study will be proposed to all patients included in LOCO-2 at discharge from the ICU. A total of 259 patients from the overall total of 850 expected inclusions in LOCO-2, will participate in the LTO-BLOXY study. These patients will be followed up to 1 year after their initial inclusion in LOCO-2, with a view to evaluate respiratory function, exercise function and cognitive function, as well as QoL.

The calendar of their study participation is as follows:

  • Inclusion in LOCO-2 study and randomization LOCO-2
  • Inclusion in LTO-BLOXY study at discharge from the ICU
  • 3 month visit ± 2 weeks (3 months after inclusion in LOCO-2 study)
  • 6 month visit ± 2 weeks (6 months after inclusion in LOCO-2 study)
  • 12 month visit ± 2 weeks (12 months after inclusion in LOCO-2 study)

At each follow-up visit, the patient will attend a consultation in the Department of Physiology - Functional Explorations, where the study questionnaires will be given to the patient for completion. The neuropsychologist will perform the cognitive tests, the respiratory function and exercise tests will also be performed at the same visit.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Outcome on Brain and Lung of Different Oxygen Strategies in ARDS Patients
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : September 20, 2021


Arm Intervention/treatment
Active Comparator: Liberal Oxygenation (LO) group

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)

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.


Experimental: Conservative Oxygenation (CO) group

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)

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.





Primary Outcome Measures :
  1. Diffusing Capacity of the Lungs for carbon monoxide (DLCO) [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Evaluation of disability (Functional Independence Measure) [ Time Frame: inclusion, 6 months ]
    FIM scale to assess the patient's performance in the activities of daily living, including cognitive and relational aspects.

  2. A binary composite morbi-mortality variable [ Time Frame: 6 months, 12 months ]

    A binary composite morbi-mortality variable defined as follow:

    • Failure: death or poor FIM
    • Success: alive and good recuperation

  3. Respiratory function: plethysmography [ Time Frame: 3 months, 6 months, 12 months ]
    Total lung capacity and functional residual capacity measured by plethysmography

  4. Respiratory function [ Time Frame: 3 months, 6 months, 12 months ]
    FEV1 and FEV1/FVC ratio

  5. Respiratory function: blood gases [ Time Frame: 3 months, 6 months, 12 months ]
    PaO2 and PaCO2 measured in room air at rest

  6. Respiratory function: inspiratory pressure [ Time Frame: 3 months, 6 months, 12 months ]
    Sniff nasal inspiratory pressure (SNIP) and maximal inspiratory pressure (PImax) (diaphragm function).

  7. Exercise function: 6-min walk test [ Time Frame: 3 months, 6 months, 12 months ]
    distance covered during a 6-minute walk test, in meters

  8. Exercise function: cyclo ergometer [ Time Frame: 6 months ]
    Physiological parameters measured at peak effort limited by symptoms on a bicycle ergometer exercise test

  9. Cognitive function: screening tests [ Time Frame: inclusion, 3 months ]
    Cognitive function will be investigated firstly through the use of rapid screening tests

  10. Cognitive function [ Time Frame: 12 months ]
    Cognitive function will be investigated secondly through an evaluation performed by a neuropsychologist through the use of the RAPID battery

  11. Quality of life: The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 3 months, 6 months, 12 months ]
    The SF36, in its validated French language version, is an established instrument used to evaluate quality of life (QoL).The questionnaire yields an overall score between 0 and 100, with a higher score indicating better QoL.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ARDS defined as a PF ratio <300
  • Patients under ventilation for <12 hours
  • Stabilization period of 3 hours with standardization of ventilation parameters

Inclusion criterion specific for neurological evaluation:

- Patient aged between 20 and 89 years

Exclusion Criteria:

  • 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

Exclusion criteria specific for neurological evaluation:

  • 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

Patients presenting exclusion criteria for the neurological evaluation can nonetheless be included in the study for the evaluation of respiratory function.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621293


Contacts
Layout table for location contacts
Contact: Bruno DEGANO, MD 3 81 21 87 45 ext +33 bruno.degano@univ-fcomte.fr
Contact: Sophie DEPIERRE 3 81 21 87 45 ext +33 sdepierre@chu-besancon.fr

Locations
Layout table for location information
France
CHU de Besançon Recruiting
Besancon, France, 25000
Contact: Bruno DEGANO       bruno.degano@univ-fcomte.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03621293     History of Changes
Other Study ID Numbers: N/2016/74
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Long term outcome
Brain
Lung
Oxygen strategies
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury