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High Flow Oxygen Therapy Versus Conventional Oxygen Therapy in Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT03282552
Recruitment Status : Active, not recruiting
First Posted : September 14, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Stavros Theologou, National and Kapodistrian University of Athens

Brief Summary:
High flow oxygen therapy has been applied after extubation in cardiac surgery patients with uncertain efficacy. The current authors plan to conduct a prospective, randomized, controlled study of nasal high flow therapy (NHF) application with high (60L/min) or low flow (40L/min) oxygen mixture administration versus standard oxygen treatment (Venturi mask) after extubation of patients undergoing elective or non-elective cardiac surgery.

Condition or disease Intervention/treatment Phase
Hypoxemic Respiratory Failure Device: Nasal Cannula High Flow Oxygen Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: High Flow Oxygen Therapy Versus Conventional Oxygen Therapy in Cardiac Surgery Patients-OPTICAR Study
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Study Group 1

The intervention consists of the implementation of Nasal Cannula High Flow Oxygenation as an oxygen treatment at Study Group 1, whereas oxygen supply was provided via Venturi mask at the standard oxygen patients' treatment.

The first Study Group will include patients on Nasal Cannula High Flow Oxygenation with initial settings of FiO2=60% and gas flow=60L/min.

Device: Nasal Cannula High Flow Oxygen
Nasal Cannula High Flow Oxygenation will be implemented at these study groups . (1st study group, and 2nd study group)

Active Comparator: Study Group 2

The intervention consists of the implementation of Nasal Cannula High Flow Oxygenation as an oxygen treatment at Study Group 2, whereas oxygen supply was provided via Venturi mask at the standard oxygen patients' treatment.

The second Study Group will include patients on Nasal Cannula High Flow Oxygenation with initial settings of FiO2=60% and gas flow=40L/min.

Device: Nasal Cannula High Flow Oxygen
Nasal Cannula High Flow Oxygenation will be implemented at these study groups . (1st study group, and 2nd study group)

No Intervention: Control group

In the third group (control group) all patients will receive oxygen treatment according to the standard practice of our cardiac ICU department, i.e., Venturi mask with FiO2=60% and flow of 15L/min.

In this group all patients will receive the usual standard of care, with no other interventions included




Primary Outcome Measures :
  1. Successful weaning from Nasal Cannula High Flow Oxygenation post extubation from cardiac surgery within 48 hours [ Time Frame: Up to 48 hours post extubation or until ICU discharge ]

    Successful weaning would be defined as = 0 when there would be avoided successfully any alternation with other mode of oxygen therapy, or re-intubation, or Non Invasive Ventilation.

    Unsuccessful weaning would be defined as =1 when there would not be avoided any alternation with other oxygen therapy, re-intubation, Non Invasive Ventilation



Secondary Outcome Measures :
  1. Successful maintenance of Respiration rate within normal range (12-20/min) on initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]

    Successful maintenance of Respiratory rate within normal range would be defined as = 0. Unsuccessful (=1) if exceeds normal range (12-20/min).

    Continuous monitoring and recording of implementation of air flow at 60L/min with Nasal Cannula High Flow Oxygenation


  2. Successful maintenance of Respiration rate within normal range (12-20/min) on initial air flow of 40 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]

    Successful maintenance of Respiratory rate within normal range would be defined as = 0. Unsuccessful (=1) if exceeds normal range (12-20/min).

    Continuous monitoring and recording of implementation of air flow at 40L/min with Nasal Cannula High Flow Oxygenation


  3. Successful maintenance of Respiration rate within normal range (12-20/min) with Venturi mask , FiO2: 60%, 15L/min [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]

    Successful maintenance of Respiratory rate within normal range (12-20/min) would be defined as = 0.

    Unsuccessful (=1) if exceeds normal range (12-20/min) Continuous monitoring and recording of implementation of Venturi mask FiO2: 60%, 15L/min


  4. Recording of pO2/FiO2 ratio with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]
    Continuous monitoring of implementation initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation

  5. Recording of pO2/FiO2 ratio with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]
    Continuous monitoring of implementation initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation

  6. Recording of pO2/FiO2 ratio with Venturi mask FiO2: 60%, 15L/min [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]
    Continuous monitoring of implementation Venturi mask, FiO2: 60%, 15L/min

  7. Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]

    Successful maintenace of saturation O2 in Hemoglobulin > 92% would be defined as = 0.

    If saturation O2 < 92 %, then it would be definded as Unsuccessful = 1 Continuous monitoring and recording of implementation initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation


  8. Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]

    Successful maintenance of saturation O2 in Hemoglobulin within normal range would be defined as = 0.

    If saturation O2 < 92 %, then it would be definded as Unsuccessful = 1

    Continuous monitoring and recording of implementation initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation


  9. Successful maintenance of saturation O2 in Hemoglobulin within normal range with Venturi mask, FiO2: 60%, 15L/min [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]

    Successful maintenance of saturation O2 in Hemoglobulin > 92% would be defined as = 0. If saturation O2 < 92 %, then would be defined as Unsuccessful = 1 .

    Continuous monitoring and recording of implementation Venturi mask FiO2 : 60%, 15L/min.


  10. Mobilization of accessory respiratory muscles with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]
    Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilization and use of accessory respiratory muscles

  11. Mobilization of accessory respiratory muscles with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]
    Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilzation and use of accessory respiratory muscles

  12. Mobilization of accessory respiratory muscles with Venturi mask, FiO2: 60%, 15L/min To record any use of accessory respiratory muscles with Venturi mask , FiO2: 60%, 15L/min [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]
    Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilzation and use of accessory respiratory muscles

  13. Comfort and tolerance of treatment with Visual Analogue Scale with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]
    To monitor and record comfort of patient with the diagnostic tool of Visual Analogue Scale

  14. Comfort and tolerance of treatment with Visual Analogue Scale with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]
    To monitor and record comfort of patient with the diagnostic tool of Visual Analogue Scale

  15. Comfort and tolerance of treatment with Visual Analogue Scale with Venturi mask , FiO2: 60%, 15L/min [ Time Frame: Post extubation period up to 48 hours or ICU discharge ]
    To monitor and record comfort of patient with the diagnostic tool of Visual Analogue Scale


Other Outcome Measures:
  1. Length of Stay in the ICU [ Time Frame: Post ICU admission period up to 48 hours or ICU discharge ]
    There will be recorded the total length of stay in the ICU since admission post surgery

  2. Length of Stay in the Hospital [ Time Frame: Post ICU admission period up to hospital discharge ]
    There will be recorded the total length of stay in the hospital since ICU admission

  3. Number of participants with death in the ICU post extubation [ Time Frame: Post ICU admission period up to 48 hours or ICU discharge ]
    There will be recorded the number of participants that will pass away post extubation in the ICU

  4. Number of participants with death in the hospital post ICU discharge [ Time Frame: Post ICU discharge period up to hospital discharge ]
    There will be recorded the number of participants that will pass away post extubation in the hospital , after the ICU discharge

  5. Number of participants with Atrial Fibrillation in the ICU post extubation [ Time Frame: Post ICU admission period up to 48 hours or ICU discharge ]
    There will be recorded the number of participants that will present Atrial Fibrillation post extubation in the ICU

  6. Number of participants with any Adverse Events in the ICU [ Time Frame: Post ICU admission period up to 48 hours or ICU discharge ]
    There will be recorded the number of participants that will present any Adverse Events (respiratory , non-respiratory) post extubation in the ICU

  7. Number of participants with any Adverse Events in the Hospital [ Time Frame: Up to 1 month, until hospital discharge ]
    There will be recorded the number of participants that will present any Adverse Events (respiratory, non-respiratory) post extubation in the ICU, until hospital discharge.

  8. Percentage of participants presenting unsuccessful (failed) implementation of NHFO treatment [ Time Frame: Post ICU admission period up to 48 hours or ICU discharge ]
    There will be recorded the number of participants that will present failure to comply with the treatment due to failing to maintain their respiratory parameters within normal range, or due to presenting intolerance and discomfort to the implementation of NHFO treatment

  9. Number of participants with re-intubation in the ICU [ Time Frame: Post ICU admission up to 48 hours or ICU discharge ]
    There will be recorded the number of participants that will be re-intubated due to deterioration of their respiratory parameters.



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

Inclusion Criteria:

  • Cardiac ICU adult patients
  • >18 years
  • After elective or urgent cardiac surgery
  • Successful Spontaneous Breathing Trial (SBT) with T-piece and FiO2=60%.
  • pO2/ FiO2 <200
  • Hemodynamically stable (160>SAP>90mmHg)

Exclusion Criteria:

  • Obstructive Sleep Apnea Syndrome supported by CPAP
  • COPD with respiratory failure,
  • Patients with tracheostomy,
  • DNR status,
  • Glasgow Coma Scale score < 13,
  • Insufficient knowledge of Greek Language
  • Visual or hearing impairment.

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): NCT03282552


Locations
Greece
Evangelismos General Hospital of Athens
Athens, Attiki, Greece, 10676
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
Study Chair: Spiros Zakynthinos, Professor National and Kapodistrian University of Athens
Study Director: Spiridon Mentzelopoulos, AssProfessor National and Kapodistrian University of Athens

Publications of Results:
34. Vats, N., Singh, J., & Kalra, S. (2012). Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. Indian Journal of Physiotherapy
43. García, G., Agosta, M., Valencia, P., Mercedes, E., & Sarhane, Y. (2017). Avoiding confusion in high fl ow oxygen therapy concepts, 1-2

Other Publications:
Responsible Party: Stavros Theologou, Principal Investigator, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03282552     History of Changes
Other Study ID Numbers: NKU Athens
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases