Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

High-Flow Nasal Cannula Versus Conventional Oxygen Therapy After Extubation in Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03441854
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
FERRONE GIULIANO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.


Condition or disease Intervention/treatment
Gas Exchange Device: HFNC group

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 L/min of heated air and oxygen at a constant fraction of inspired oxygen (FiO 2 ) up to 1.0. 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 (5,6), 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 patient's 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Effects of High-Flow Nasal Cannula Versus Conventional Oxygen Therapy After Extubation in Liver Transplantation: Matched Control Study.
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HFNC group
The investigators will prospectively include 30 patients admitted to 13- bed PICU after liver transplantation and treated with HFNC oxygen delivery after extubation.
Device: HFNC group
Application of HFNC oxygen delivery after extubation.

Control Group
For each study group patient, a match control subject (matching criteria: age ± 10%, PaO2/FiO2 ± 30, diagnosis, Model for End-Stage Liver Disease (MELD) ± 10%) will be chosen from a group of 70 patients treated with conventional oxygen delivery (Venturi Mask) during the previous 2 years.



Primary Outcome Measures :
  1. Post- operative oxygenation [ Time Frame: 1 hour after extubaton ]
    Evaluation of post-operative oxygenation measured at 1 hour after extubation


Secondary Outcome Measures :
  1. Re-intubation rate [ Time Frame: 1 week after extubaton ]
    Evaluation of re-intubation incidence at 1 week after extubation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

According with PICU Weaning protocol from mechanical ventilation, the investigators will be performed weaning trial and extubation after the evaluation of following conditions: 1) hemodynamic stability; 2) minimal ventilator support (pressure support ≤10 cm H2O with positive end-expiratory pressure ≤ 5 cm H2O); 3) adequate spontaneous breathing (Respiratory Rate < 25 breath.min-1).

Successfully completed the weaning trial, the patients will be extubated and will be received humidified oxygen by HFNC at the same FiO2 as the invasive mechanical ventilation with endotracheal tube and flow rate 60 L.min

Criteria

Inclusion Criteria:

  • Liver transplantation surgery
  • Presence of criteria to start a weaning trial

Exclusion Criteria:

  • Patient < 18 years
  • Need of cardiovascular resuscitation
  • Glasgow Coma Score ≤ 8
  • Hemodynamic instability

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): NCT03441854


Locations
Layout table for location information
Italy
Fondazione Policlinico Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
Layout table for investigator information
Principal Investigator: Giuliano Ferrone, MD Fondazione Policlinico Gemelli
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: FERRONE GIULIANO, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT03441854    
Other Study ID Numbers: 1701/18
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FERRONE GIULIANO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Gas exchange
Non invasive ventilation
Liver transplantation