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

NCT03441854 | Completed

• 1 other identifier: 1701/18
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gas Exchange

Keywords

Gas exchange; Non invasive ventilation; Liver transplantation

Outcome Measures

Primary Outcomes (1)

• Post- operative oxygenation

  Evaluation of post-operative oxygenation measured at 1 hour after extubation

  1 hour after extubaton

Secondary Outcomes (1)

• Re-intubation rate

  1 week after extubaton

Study Arms (2)

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

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.

Interventions

HFNC group DEVICE

Application of HFNC oxygen delivery after extubation.

HFNC group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli

Rome, 00168, Italy

Location

Related Publications (4)

• Corley A, Rickard CM, Aitken LM, Johnston A, Barnett A, Fraser JF, Lewis SR, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2017 May 30;5(5):CD010172. doi: 10.1002/14651858.CD010172.pub2.

  PMID: 28555461 BACKGROUND

• 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.

  PMID: 27997805 BACKGROUND

• Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.

  PMID: 27771739 BACKGROUND

• Gaspari R, Spinazzola G, Ferrone G, Soave PM, Pintaudi G, Cutuli SL, Avolio AW, Conti G, Antonelli M. High-Flow Nasal Cannula Versus Standard Oxygen Therapy After Extubation in Liver Transplantation: A Matched Controlled Study. Respir Care. 2020 Jan;65(1):21-28. doi: 10.4187/respcare.06866. Epub 2019 Jul 3.

  PMID: 31270177 DERIVED

Study Officials

• Giuliano Ferrone, MD

  Fondazione Policlinico Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 22, 2018
• Study Start: June 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: December 31, 2018
• Last Updated: October 6, 2021

Record last verified: 2021-09

Locations

IT (1)