Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521489
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Asymmetrical HFNCO vs Standard HFNCO Post Cardiac Surgery Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Asymmetrical High Flow Nasal Cannula Oxygenation HFNCO vs Standard HFNCO on Cardiac Surgical Patients Postoperatively
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
High-flow oxygen therapy has been applied after extubation in cardiac surgery patients with a well-known successful efficacy The current authors plan to conduct a prospective randomized controlled study of the Asymmetrical device Nasal Cannula High Flow Oxygenation HFNCO application on high flow 60Lmin with 60 fiO2 administration versus Conventional device Nasal Cannula High Flow Oxygenation HFNCO application on high flow 60Lmin with 60 fiO2 administration and versus Conventional oxygen treatment Venturi mask after extubation of patients undergoing elective or non-elective cardiac surgery
Detailed Description:
Over the last decade High Flow Nasal Cannula OxygenationHFNCO has proven successfully its capability in the management of hypoxemic respiratory failure patients post cardiac surgery Efficient oxygenation has been recorded in meta-analyses on study population research with BMI 30 Moreover in a recent meta-analysis it has been documented that the use of HFNCO required less need for upgrade of respiratory support Similar findings were documented in a study of two different variations of HFNCO treatment as compared with Conventional oxygen therapy Venturi mask
A modified version Asymmetrical of HFNCO came on the surface recently whereas the L nasal prong has a larger diameter compared with the R prong of the nasal cannula
Research results on hypoxemic patients and laboratory models also revealed interesting measurements on specific respiratory parameters such as minute volume ventilation respiratory rate and work of breathing as compared with conventional HFNCO In addition there were documented higher resistance flow rates which achieved higher PEEP rates in favor of lung alveoli
On the other hand there exists documentation with positive aspects that support the use of a non-rebreathing mask Venturi mask or surgical mask fixed on top of nasal prongs of HFNCO to augment the fiO2 which finally ends up on the patient
Aim of the study The primary goal of the study is the efficacy of the Asymmetrical HFNCO on cardiac surgical patients post-extubation as compared with Conventional HFNCO The secondary goal of the study is the comparison of initial Asymmetrical HFNCO parameters versus a the avoidance of upgrading Asymmetrical HFNCO supported by a non-rebreathing mask fixed on top of that versus b the avoidance of upgrading Asymmetrical HFNCO to Non-Invasive Ventilation NIV
The tertiary goal of the study is the comparison of all three patient groups a Asymmetrical HFNCO 60Lmin FiO2 60 b Conventional HFNCO 60lmin FiO2 60 c Conventional oxygen therapy Venturi mask 12lmin FiO2 60 regarding the use of treatment on patients with ΒΜΙ 30 and regarding respiratory parameters respiratory rate pO2 FiO2 spO2 use of accessory muscles dyspnoea comfort and tolerance by using the visual analog scale
Additional goals of the study are to compare all three patient groups regarding 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 respiratory-chest infection pneumothorax delirium grand mal acute renal failure major bleeding - tamponade cardiac arrest 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
1 Asymmetrical HFNCO 60lmin FiO2 60
2 Conventional HFNCO 60lmin FiO2 60
3 Conventional oxygen therapy Venturi mask 12lmin FiO2 60
Treatment failure will be defined as any crossover from one treatment to another due to the patients respiratory distress and discomfort To be more specific switch from Asymmetrical HFNCO to Conventional HFNCO or switch from Asymmetrical HFNCO to Conventional oxygen therapy supported by a non-rebreathing mask fixed on top of a nasal cannula 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 FiO2gas-mixture flow escalation might be needed either it is being recorded in study groups 1 2 or control group
Failure would also defined as any irreversible 48 hours crossover from either the HFNCO group to standard practice Venturi mask or the need for more advanced respiratory support such as non-invasive ventilation or invasive mechanical ventilation
An initial power analysis was based on a predicted average failure rate of 15 in the HFNCO groups and a failure rate of 51 in the control group this analysis yielded the need for enrollment of a total of 41 HFNCO patients and 21 controls for alpha 005 and power080 To ensure equal numbers of patients in each one of the 2 HFNCO groups the authors decided to enroll 42 HFNCO patients n21 for each NHF group and 21 controls resulting in a total enrollment of 63 patients
A modified version Asymmetrical of HFNCO came on the surface recently whereas the L nasal prong has a larger diameter compared with the R prong of the nasal cannula
Research results on hypoxemic patients and laboratory models also revealed interesting measurements on specific respiratory parameters such as minute volume ventilation respiratory rate and work of breathing as compared with conventional HFNCO In addition there were documented higher resistance flow rates which achieved higher PEEP rates in favor of lung alveoli
On the other hand there exists documentation with positive aspects that support the use of a non-rebreathing mask Venturi mask or surgical mask fixed on top of nasal prongs of HFNCO to augment the fiO2 which finally ends up on the patient
Aim of the study The primary goal of the study is the efficacy of the Asymmetrical HFNCO on cardiac surgical patients post-extubation as compared with Conventional HFNCO The secondary goal of the study is the comparison of initial Asymmetrical HFNCO parameters versus a the avoidance of upgrading Asymmetrical HFNCO supported by a non-rebreathing mask fixed on top of that versus b the avoidance of upgrading Asymmetrical HFNCO to Non-Invasive Ventilation NIV
The tertiary goal of the study is the comparison of all three patient groups a Asymmetrical HFNCO 60Lmin FiO2 60 b Conventional HFNCO 60lmin FiO2 60 c Conventional oxygen therapy Venturi mask 12lmin FiO2 60 regarding the use of treatment on patients with ΒΜΙ 30 and regarding respiratory parameters respiratory rate pO2 FiO2 spO2 use of accessory muscles dyspnoea comfort and tolerance by using the visual analog scale
Additional goals of the study are to compare all three patient groups regarding 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 respiratory-chest infection pneumothorax delirium grand mal acute renal failure major bleeding - tamponade cardiac arrest 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
1 Asymmetrical HFNCO 60lmin FiO2 60
2 Conventional HFNCO 60lmin FiO2 60
3 Conventional oxygen therapy Venturi mask 12lmin FiO2 60
Treatment failure will be defined as any crossover from one treatment to another due to the patients respiratory distress and discomfort To be more specific switch from Asymmetrical HFNCO to Conventional HFNCO or switch from Asymmetrical HFNCO to Conventional oxygen therapy supported by a non-rebreathing mask fixed on top of a nasal cannula 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 FiO2gas-mixture flow escalation might be needed either it is being recorded in study groups 1 2 or control group
Failure would also defined as any irreversible 48 hours crossover from either the HFNCO group to standard practice Venturi mask or the need for more advanced respiratory support such as non-invasive ventilation or invasive mechanical ventilation
An initial power analysis was based on a predicted average failure rate of 15 in the HFNCO groups and a failure rate of 51 in the control group this analysis yielded the need for enrollment of a total of 41 HFNCO patients and 21 controls for alpha 005 and power080 To ensure equal numbers of patients in each one of the 2 HFNCO groups the authors decided to enroll 42 HFNCO patients n21 for each NHF group and 21 controls resulting in a total enrollment of 63 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None