High Flow Oxygen Therapy Versus Conventional Oxygen Therapy in Cardiac Surgery Patients
NCT ID: NCT03282552
Last Updated: 2024-07-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
99 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-30
Study Completion Date
2019-10-17
Brief Summary
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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.
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Detailed Description
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Over the past decade, nasal high flow (NHF) has been introduced for oxygen therapy in adults. Its indications have been expanded, especially in cases of acute hypoxemic respiratory failure.
The device consists of an air/oxygen blender connected via an active heated humidifier to a nasal cannula, through a single limb, heated inspiratory circuit. It delivers a fraction of inspired oxygen (FiO2) from 21% to 100% with a flow rate up to 60 L/min. FiO2 adjustments are independent of the set flow rate so that the patient is given heated, humidified high-flow oxygen, with a flow that can be adjusted above the patient's maximum inspiratory flow rate, thereby increasing confidence about the actual FiO2 being delivered to the patient. These device characteristics make it more promising in comparison with conventional low- and high-flow oxygen devices (e.g., nasal cannula, non-rebreathing masks, Venturi masks), especially in patients with high inspiratory flow rates, such as patients with acute respiratory failure (ARF).
The benefits arising from application of oxygen with high flow rates via NHF are
1. reduction in the entrainment of room air and thus ensuring higher and more stable FiO2 values,
2. generation of positive airway pressures during expiration as a result of the expiratory resistance imposed to the patient's exhalation against the continuous high flow of incoming oxygen gas,
3. improving mucociliary function and clearance of secretion by continuous heating and humidifying of the administered gas,
4. reducing dead space ventilation and
5. reducing work of breathing. All the aforementioned NHF mechanisms of actions exert various effects on the respiratory system, including improved gas exchange, lower respiratory rate and effort and improved lung mechanics which are correlated with more comfort and less subjective dyspnea.
Respiratory complications after cardiac surgery can affect morbidity and mortality, and increase the healthcare cost. Advanced age, duration of extracorporeal circulation, history of significant underlying cardiac or pulmonary disease and phrenic nerve injury are the main prognostic factors for post cardiac surgery respiratory complications.
Traditionally, low- and high-flow oxygen systems are used to reverse postsurgical respiratory complications with or without addition of continuous (CPAP) or bi-level (NIV) positive airway pressure.
NHF might be superior for the prevention or treatment of those respiratory complications, since it can provide high-flow of heated and hydrated oxygen while the positive airway pressure created by the high gas flow can recruit alveoli and increase the end-expiratory lung volume.
Studies applying NHF immediately after extubation in cardiac surgery patients revealed better oxygenation and less need for advanced methods of respiratory support compared to conventional oxygen devices , and similar results compared to noninvasive ventilation. However, Zochios et al, summarized all the available up to date data of NHF compared to conventional oxygen devices and non-invasive ventilation in patients undergoing cardiothoracic surgery and they did not find any further benefit by NHF use. The aforementioned discrepancy could be explained by the differences in the studied populations and NHF flow settings. The proposed initial flow rate differs among the studies, with some authors suggesting initial lower flows (35-40 L/min) that will be better tolerated by the patients and others suggesting initial maximal flows (60 L/min) to rapidly relieve dyspnea and prevent muscle fatigue.
Aim The primary goal of the study is to evaluate the efficacy of NHF (with initial flows of 60 L/min or 40 L/min) versus conventional oxygen systems on respiratory parameters (respiratory rate, pO2/ FiO2, spO2, use of accessory muscles, dyspnoea, comfort and tolerance by using the visual analogue scale) immediately after the extubation of cardiac surgery patients.
Additional goals of the study are to compare two different initial NHF flows of 60 L/min and 40 L/min, ICU Length of Stay, Hospital Length of Stay, rates of ICU re-admission and re-intubation and any other respiratory / non-respiratory complications and adverse events. Moreover, the rate of failure of the initial treatment will be recorded (as a major measure of treatment efficacy).
Method
This is a prospective, non-blinded, randomized study in post-extubated cardiac surgery patients. The study population will consist of three patient groups:
The first group (Study Group 1) will include patients on NHF with initial settings of FiO2=60% and gas flow=60L/min.
The second group (Study Group 2) will include patients on NHF with initial settings of FiO2=60% and gas flow=40L/min In the third group (control group) all patients will receive oxygen therapy according to the standard practice of our cardiac ICU department, i.e., Venturi mask with FiO2=60% and flow of 15L/min.
Patients in both study groups would be weaned off the NHF as follows; First reducing FiO2 gradually to 50%, and then gradually reducing the gas flow (either from 60l/min or 40/min, depending on the study group) down to 30l/min, aiming at the final wean-off goal of 20l/min, unless the attending physician decides to wean-off patient to Venturi mask directly from a higher gas flow supply (e.g.: 30-25l/min) Treatment failure will be defined as any crossover from one treatment to another due to patient's respiratory distress and discomfort. To be more specific, switch of gas flow from 40L/min to 60L/min, crossover from either NHF group to standard practice (Venturi mask) or need for more advanced respiratory support such as non-invasive ventilation or invasive mechanical ventilation.
Any implemented treatment would also be defined as "failure" when any irreversible (for at least 48 hours) FiO2/gas-mixture flow escalation might be needed, either it is being recorded on Study group 1 \& 2 or Control group.
An initial power analysis was based on a predicted, average failure rate of 15% in the 2 NHF groups and a failure rate of 51% in the control group; this analysis yielded the need for enrollment of a total of 41 NHF patients and 21 controls for alpha = 0.05 and power=0.80. To ensure equal numbers of patients in each one of the 2 NHF groups, the authors decided to actually enroll 42 NHF patients (n=21 for each NHF group) and 21 controls, resulting in a total enrollment of 63 patients. At one year after study initiation, actual, total enrollment amounted to 45 patients. At this time point, the Data Monitoring Committee (after confirming the safe application of the study protocol) recommended the continuation of the study until the enrollment of 99 patients (n=33 for each one of the 3 groups); the rationale for this was to compensate for possible dropouts and/or missing data (especially for the secondary and "other" outcomes). Accordingly, the study was completed with an actual enrollment of 99 patients.
The device consists of an air/oxygen blender connected via an active heated humidifier to a nasal cannula, through a single limb, heated inspiratory circuit. It delivers a fraction of inspired oxygen (FiO2) from 21% to 100% with a flow rate up to 60 L/min. FiO2 adjustments are independent of the set flow rate so that the patient is given heated, humidified high-flow oxygen, with a flow that can be adjusted above the patient's maximum inspiratory flow rate, thereby increasing confidence about the actual FiO2 being delivered to the patient. These device characteristics make it more promising in comparison with conventional low- and high-flow oxygen devices (e.g., nasal cannula, non-rebreathing masks, Venturi masks), especially in patients with high inspiratory flow rates, such as patients with acute respiratory failure (ARF).
The benefits arising from application of oxygen with high flow rates via NHF are
1. reduction in the entrainment of room air and thus ensuring higher and more stable FiO2 values,
2. generation of positive airway pressures during expiration as a result of the expiratory resistance imposed to the patient's exhalation against the continuous high flow of incoming oxygen gas,
3. improving mucociliary function and clearance of secretion by continuous heating and humidifying of the administered gas,
4. reducing dead space ventilation and
5. reducing work of breathing. All the aforementioned NHF mechanisms of actions exert various effects on the respiratory system, including improved gas exchange, lower respiratory rate and effort and improved lung mechanics which are correlated with more comfort and less subjective dyspnea.
Respiratory complications after cardiac surgery can affect morbidity and mortality, and increase the healthcare cost. Advanced age, duration of extracorporeal circulation, history of significant underlying cardiac or pulmonary disease and phrenic nerve injury are the main prognostic factors for post cardiac surgery respiratory complications.
Traditionally, low- and high-flow oxygen systems are used to reverse postsurgical respiratory complications with or without addition of continuous (CPAP) or bi-level (NIV) positive airway pressure.
NHF might be superior for the prevention or treatment of those respiratory complications, since it can provide high-flow of heated and hydrated oxygen while the positive airway pressure created by the high gas flow can recruit alveoli and increase the end-expiratory lung volume.
Studies applying NHF immediately after extubation in cardiac surgery patients revealed better oxygenation and less need for advanced methods of respiratory support compared to conventional oxygen devices , and similar results compared to noninvasive ventilation. However, Zochios et al, summarized all the available up to date data of NHF compared to conventional oxygen devices and non-invasive ventilation in patients undergoing cardiothoracic surgery and they did not find any further benefit by NHF use. The aforementioned discrepancy could be explained by the differences in the studied populations and NHF flow settings. The proposed initial flow rate differs among the studies, with some authors suggesting initial lower flows (35-40 L/min) that will be better tolerated by the patients and others suggesting initial maximal flows (60 L/min) to rapidly relieve dyspnea and prevent muscle fatigue.
Aim The primary goal of the study is to evaluate the efficacy of NHF (with initial flows of 60 L/min or 40 L/min) versus conventional oxygen systems on respiratory parameters (respiratory rate, pO2/ FiO2, spO2, use of accessory muscles, dyspnoea, comfort and tolerance by using the visual analogue scale) immediately after the extubation of cardiac surgery patients.
Additional goals of the study are to compare two different initial NHF flows of 60 L/min and 40 L/min, ICU Length of Stay, Hospital Length of Stay, rates of ICU re-admission and re-intubation and any other respiratory / non-respiratory complications and adverse events. Moreover, the rate of failure of the initial treatment will be recorded (as a major measure of treatment efficacy).
Method
This is a prospective, non-blinded, randomized study in post-extubated cardiac surgery patients. The study population will consist of three patient groups:
The first group (Study Group 1) will include patients on NHF with initial settings of FiO2=60% and gas flow=60L/min.
The second group (Study Group 2) will include patients on NHF with initial settings of FiO2=60% and gas flow=40L/min In the third group (control group) all patients will receive oxygen therapy according to the standard practice of our cardiac ICU department, i.e., Venturi mask with FiO2=60% and flow of 15L/min.
Patients in both study groups would be weaned off the NHF as follows; First reducing FiO2 gradually to 50%, and then gradually reducing the gas flow (either from 60l/min or 40/min, depending on the study group) down to 30l/min, aiming at the final wean-off goal of 20l/min, unless the attending physician decides to wean-off patient to Venturi mask directly from a higher gas flow supply (e.g.: 30-25l/min) Treatment failure will be defined as any crossover from one treatment to another due to patient's respiratory distress and discomfort. To be more specific, switch of gas flow from 40L/min to 60L/min, crossover from either NHF group to standard practice (Venturi mask) or need for more advanced respiratory support such as non-invasive ventilation or invasive mechanical ventilation.
Any implemented treatment would also be defined as "failure" when any irreversible (for at least 48 hours) FiO2/gas-mixture flow escalation might be needed, either it is being recorded on Study group 1 \& 2 or Control group.
An initial power analysis was based on a predicted, average failure rate of 15% in the 2 NHF groups and a failure rate of 51% in the control group; this analysis yielded the need for enrollment of a total of 41 NHF patients and 21 controls for alpha = 0.05 and power=0.80. To ensure equal numbers of patients in each one of the 2 NHF groups, the authors decided to actually enroll 42 NHF patients (n=21 for each NHF group) and 21 controls, resulting in a total enrollment of 63 patients. At one year after study initiation, actual, total enrollment amounted to 45 patients. At this time point, the Data Monitoring Committee (after confirming the safe application of the study protocol) recommended the continuation of the study until the enrollment of 99 patients (n=33 for each one of the 3 groups); the rationale for this was to compensate for possible dropouts and/or missing data (especially for the secondary and "other" outcomes). Accordingly, the study was completed with an actual enrollment of 99 patients.
Conditions
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Hypoxemic Respiratory Failure
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Nasal Cannula High Flow Oxygen
Intervention Type
DEVICE
Nasal Cannula High Flow Oxygenation will be implemented at these study groups . (1st study group, and 2nd study group)
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.
Group Type
ACTIVE_COMPARATOR
Nasal Cannula High Flow Oxygen
Intervention Type
DEVICE
Nasal Cannula High Flow Oxygenation will be implemented at these study groups . (1st study group, and 2nd study group)
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
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Nasal Cannula High Flow Oxygen
Nasal Cannula High Flow Oxygenation will be implemented at these study groups . (1st study group, and 2nd study group)
Intervention Type
DEVICE
Eligibility Criteria
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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)
* \>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, 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Sponsor Role
lead
Responsible Party
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Stavros Theologou
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Spiros Zakynthinos, Professor
Role: STUDY_CHAIR
National and Kapodistrian University of Athens
Spiridon Mentzelopoulos, AssProfessor
Role: STUDY_DIRECTOR
National and Kapodistrian University of Athens
Locations
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Evangelismos General Hospital of Athens
Athens, Attica, Greece
Site Status
Countries
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Greece
References
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Pellegrini JA, Moraes RB, Maccari JG, de Oliveira RP, Savi A, Ribeiro RA, Burns KE, Teixeira C. Spontaneous Breathing Trials With T-Piece or Pressure Support Ventilation. Respir Care. 2016 Dec;61(12):1693-1703. doi: 10.4187/respcare.04816. Epub 2016 Sep 6.
Reference Type
BACKGROUND
Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S. Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol. 2013 Dec;79(12):1344-55. Epub 2013 Jul 15.
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RESULT
Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.
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RESULT
Ritchie JE, Williams AB, Gerard C, Hockey H. Evaluation of a humidified nasal high-flow oxygen system, using oxygraphy, capnography and measurement of upper airway pressures. Anaesth Intensive Care. 2011 Nov;39(6):1103-10. doi: 10.1177/0310057X1103900620.
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RESULT
Gotera C, Diaz Lobato S, Pinto T, Winck JC. Clinical evidence on high flow oxygen therapy and active humidification in adults. Rev Port Pneumol. 2013 Sep-Oct;19(5):217-27. doi: 10.1016/j.rppneu.2013.03.005. Epub 2013 Jul 8.
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RESULT
Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20.
Reference Type
RESULT
Groves N, Tobin A. High flow nasal oxygen generates positive airway pressure in adult volunteers. Aust Crit Care. 2007 Nov;20(4):126-31. doi: 10.1016/j.aucc.2007.08.001. Epub 2007 Oct 10.
Reference Type
RESULT
Parke RL, Eccleston ML, McGuinness SP. The effects of flow on airway pressure during nasal high-flow oxygen therapy. Respir Care. 2011 Aug;56(8):1151-5. doi: 10.4187/respcare.01106. Epub 2011 Apr 15.
Reference Type
RESULT
Parke RL, McGuinness SP. Pressures delivered by nasal high flow oxygen during all phases of the respiratory cycle. Respir Care. 2013 Oct;58(10):1621-4. doi: 10.4187/respcare.02358. Epub 2013 Mar 19.
Reference Type
RESULT
Chikata Y, Izawa M, Okuda N, Itagaki T, Nakataki E, Onodera M, Imanaka H, Nishimura M. Humidification performance of two high-flow nasal cannula devices: a bench study. Respir Care. 2014 Aug;59(8):1186-90. doi: 10.4187/respcare.02932.
Reference Type
RESULT
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Reference Type
RESULT
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Reference Type
RESULT
Moller W, Feng S, Domanski U, Franke KJ, Celik G, Bartenstein P, Becker S, Meyer G, Schmid O, Eickelberg O, Tatkov S, Nilius G. Nasal high flow reduces dead space. J Appl Physiol (1985). 2017 Jan 1;122(1):191-197. doi: 10.1152/japplphysiol.00584.2016. Epub 2016 Nov 17.
Reference Type
RESULT
Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
Reference Type
RESULT
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Reference Type
RESULT
Frizzola M, Miller TL, Rodriguez ME, Zhu Y, Rojas J, Hesek A, Stump A, Shaffer TH, Dysart K. High-flow nasal cannula: impact on oxygenation and ventilation in an acute lung injury model. Pediatr Pulmonol. 2011 Jan;46(1):67-74. doi: 10.1002/ppul.21326. Epub 2010 Nov 23.
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RESULT
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RESULT
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RESULT
Weissman C. Pulmonary complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):185-211. doi: 10.1177/108925320400800303.
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RESULT
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Reference Type
RESULT
Auriant I, Jallot A, Herve P, Cerrina J, Le Roy Ladurie F, Fournier JL, Lescot B, Parquin F. Noninvasive ventilation reduces mortality in acute respiratory failure following lung resection. Am J Respir Crit Care Med. 2001 Oct 1;164(7):1231-5. doi: 10.1164/ajrccm.164.7.2101089.
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RESULT
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RESULT
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RESULT
Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
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RESULT
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RESULT
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RESULT
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RESULT
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RESULT
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RESULT
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Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.
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Lopez MG, Pandharipande P, Morse J, Shotwell MS, Milne GL, Pretorius M, Shaw AD, Roberts LJ 2nd, Billings FT 4th. Intraoperative cerebral oxygenation, oxidative injury, and delirium following cardiac surgery. Free Radic Biol Med. 2017 Feb;103:192-198. doi: 10.1016/j.freeradbiomed.2016.12.039. Epub 2016 Dec 27.
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Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
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Pun BT, Devlin JW. Delirium monitoring in the ICU: strategies for initiating and sustaining screening efforts. Semin Respir Crit Care Med. 2013 Apr;34(2):179-88. doi: 10.1055/s-0033-1342972. Epub 2013 May 28.
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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NKU Athens
Identifier Type: -
Identifier Source: org_study_id
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