Ignite Creation Date:
2024-05-06 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03441854
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2018-02-05
Brief Title:
High-Flow Nasal Cannula Versus Conventional Oxygen Therapy After Extubation in Liver Transplantation
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Effects of High-Flow Nasal Cannula Versus Conventional Oxygen Therapy After Extubation in Liver Transplantation Matched Control Study
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Humidified oxygen therapy via high-flow nasal cannula HFNC is a recently available technique delivering heated and humidified high flow oxygen through simple nasal prongs In immunocompetent patients HFNC can help generating low levels of Continuous Positive Airway Pressure CPAP due to the high flow of fresh gas improving comfort and oxygenation and it attenuates signs of respiratory distress compared with non-rebreathing oxygen face mask such as Venturi mask Moreover HFNC is considered to have several physiological advantages compared with other standard oxygen therapies including the provision of positive end-expiratory pressure PEEP constant inspiratory oxygen fraction FiO2 and good humidification More importantly it can reduce the anatomical dead space For its advantages over conventional oxygen delivery system in patients undergoing abdominal surgery or Thoracoscopic Lobectomy the investigators are currently and according to clinical practice using HFNC oxygen delivery in Liver transplantation after extubation in our Post-Operative Intensive Care Unit PICU
Due to recipients generally poor preoperative clinical conditions the extensive surgical field and long operating times post-operative respiratory disorders are very common after liver transplantation and they significantly contribute to the related morbidity and mortality both in the acute postoperative stage and in the long term Several factors are involved in the onset of postoperative pulmonary complications PPCs and many preoperative and intraoperative variables have been associated with different degrees of severity of respiratory impairment after liver transplantation In the early stages after transplantation pulmonary complications may prolong intubation time and increase the risk of systemic infective complications Prolonged mechanical ventilation due to refractory respiratory failure is an extremely morbid event as this event is a marker of poor recipient recovery predisposes a recipient to long term ventilator dependency and predicts further complications
In this matched control study the investigators hypothesize that HFNC treatment might be superior to conventional oxygen therapy in terms of post-operative gas exchange and post-operative pulmonary complications for patients undergoing liver transplantation after extubation
Due to recipients generally poor preoperative clinical conditions the extensive surgical field and long operating times post-operative respiratory disorders are very common after liver transplantation and they significantly contribute to the related morbidity and mortality both in the acute postoperative stage and in the long term Several factors are involved in the onset of postoperative pulmonary complications PPCs and many preoperative and intraoperative variables have been associated with different degrees of severity of respiratory impairment after liver transplantation In the early stages after transplantation pulmonary complications may prolong intubation time and increase the risk of systemic infective complications Prolonged mechanical ventilation due to refractory respiratory failure is an extremely morbid event as this event is a marker of poor recipient recovery predisposes a recipient to long term ventilator dependency and predicts further complications
In this matched control study the investigators hypothesize that HFNC treatment might be superior to conventional oxygen therapy in terms of post-operative gas exchange and post-operative pulmonary complications for patients undergoing liver transplantation after extubation
Detailed Description:
Humidified oxygen therapy via high-flow nasal cannula HFNC is a recently available technique delivering heated and humidified high flow oxygen through simple nasal prongs HFNC provides flows up to 60 Lmin of heated air and oxygen at a constant fraction of inspired oxygen FiO 2 up to 10 Several studies 1-3 have demonstrated that in immunocompetent patients HFNC can help generating low levels of CPAP due to the high flow of fresh gas improving comfort and oxygenation and it attenuates signs of respiratory distress compared with non-rebreathing oxygen face mask such as Venturi mask Moreover HFNC is considered to have several physiological advantages compared with other standard oxygen therapies including the provision of positive end-expiratory pressure PEEP constant FiO2 and good humidification More importantly it can reduce the anatomical dead space Several studies 1-4 demonstrated the efficacy of HFNC in reducing signs of respiratory distress compared to conventional oxygen delivery such as Venturi mask For its advantages over conventional oxygen delivery system in patients undergoing abdominal surgery or Thoracoscopic Lobectomy 56 the investigators are currently and according to clinical practice using HFNC oxygen delivery in Liver transplantation after extubation in our Post-Operative Intensive Care Unit PICU
Due to recipients generally poor preoperative clinical conditions the extensive surgical field and long operating times post-operative respiratory disorders are very common after liver transplantation and they significantly contribute to the related morbidity and mortality both in the acute postoperative stage and in the long term Several factors are involved in the onset of postoperative pulmonary complications PPCs and many preoperative and intraoperative variables have been associated with different degrees of severity of respiratory impairment after liver transplantation 7 Although refinements in surgical techniques antimicrobial prophylaxis immunosuppression anesthesia and intensive care management have most likely altered the frequency and overall spectrum of post-liver transplantation respiratory disorders it is still common for pulmonary infiltrates atelectasis pleural exudates and other radiological abnormalities to be documented on chest X-ray at any time during a patients stay at an intensive care unit All of these respiratory disorders can affect lung compliance and alveolar gas exchange and when severe may necessitate tracheal intubation and mechanical ventilation In the early stages after transplantation pulmonary complications may prolong intubation time and increase the risk of systemic infective complications Prolonged mechanical ventilation due to refractory respiratory failure is an extremely morbid event as this event is a marker of poor recipient recovery predisposes a recipient to long term ventilator dependency and predicts further complications
In this patients with high risk of PPCs the application of increased flow rates through HFNC could progressively reduce inspiratory effort and improve lung aeration dynamic compliance and oxygenation as demonstrated in patients with acute hypoxemic respiratory failure 8
In this matched control study the investigators hypothesize that HFNC treatment might be superior to conventional oxygen therapy in terms of post-operative gas exchange and post-operative pulmonary complications for patients undergoing liver transplantation after extubation
Due to recipients generally poor preoperative clinical conditions the extensive surgical field and long operating times post-operative respiratory disorders are very common after liver transplantation and they significantly contribute to the related morbidity and mortality both in the acute postoperative stage and in the long term Several factors are involved in the onset of postoperative pulmonary complications PPCs and many preoperative and intraoperative variables have been associated with different degrees of severity of respiratory impairment after liver transplantation 7 Although refinements in surgical techniques antimicrobial prophylaxis immunosuppression anesthesia and intensive care management have most likely altered the frequency and overall spectrum of post-liver transplantation respiratory disorders it is still common for pulmonary infiltrates atelectasis pleural exudates and other radiological abnormalities to be documented on chest X-ray at any time during a patients stay at an intensive care unit All of these respiratory disorders can affect lung compliance and alveolar gas exchange and when severe may necessitate tracheal intubation and mechanical ventilation In the early stages after transplantation pulmonary complications may prolong intubation time and increase the risk of systemic infective complications Prolonged mechanical ventilation due to refractory respiratory failure is an extremely morbid event as this event is a marker of poor recipient recovery predisposes a recipient to long term ventilator dependency and predicts further complications
In this patients with high risk of PPCs the application of increased flow rates through HFNC could progressively reduce inspiratory effort and improve lung aeration dynamic compliance and oxygenation as demonstrated in patients with acute hypoxemic respiratory failure 8
In this matched control study the investigators hypothesize that HFNC treatment might be superior to conventional oxygen therapy in terms of post-operative gas exchange and post-operative pulmonary complications for patients undergoing liver transplantation after extubation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None