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

NCT03282552 | Completed DMC

• 1 other identifier: NKU Athens
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Successful weaning (i.e. absence of treatment failure) from Nasal Cannula High Flow Oxygenation post extubation from cardiac surgery within at least 48 hours

  Successful weaning (i.e. absence of treatment failure as further described in methods) 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. For all groups: Unsuccessful weaning (i.e. actual treatment failure as further described in methods) would be defined as =1 when there would not be avoided any alternation with other oxygen therapy, re-intubation, Non Invasive Ventilation

  Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)

Secondary Outcomes (15)

• 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

  Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)

• 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

  Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)

• Successful maintenance of Respiration rate within normal range (12-20/min) with Venturi mask , FiO2: 60%, 15L/min

  Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)

• Recording of pO2/FiO2 ratio with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation

  Post extubation period up to 48 hours or ICU discharge

• Recording of pO2/FiO2 ratio with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation

  Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)

Other Outcomes (9)

• Length of Stay in the ICU

  Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge

• Length of Stay in the Hospital

  Post ICU admission period up to actual hospital discharge

• Number of participants with death in the cardiothoracic ICU post extubation

  Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge

Study Arms (3)

Study Group 1

ACTIVE COMPARATOR

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

Study Group 2

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

Nasal Cannula High Flow Oxygen DEVICE

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

Study Group 1; Study Group 2

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• Obstructive Sleep Apnea Syndrome supported by CPAP
• COPD, officially diagnosed, respiratory failure with serum blood ph \<7,35.
• Patients with tracheostomy,
• DNR status,
• Glasgow Coma Scale score \< 13,
• Insufficient knowledge of Greek Language
• Visual or hearing impairment.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Evangelismos General Hospital of Athens

Athens, Attica, 10676, Greece

Location

Related Publications (46)

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MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Spiros Zakynthinos, Professor

  National and Kapodistrian University of Athens

  STUDY CHAIR

• Spiridon Mentzelopoulos, AssProfessor

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: September 14, 2017
• Study Start: October 30, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 17, 2019
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)