High-Flow Nasal Catheter (HFNC) Compared With Conventional Oxygenation

Thoracic Surgery Clinical Trial

Official title:

High-Flow Nasal Catheter (HFNC) Compared With Conventional Oxygenation During the Perioperative Period of Patients Undergoing Thoracic Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910788
• Other study ID #: U1111-1292-9259
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: Federal University of Rio Grande do Sul
• Contact: Desire Maioli
• Phone: 55(54)999556129
• Email: desiremaioli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study, is to clarify whether there is benefit from the perioperative use of HFNC in thoracic surgeries, from intubation to the postoperative period, evaluating hipoxemia during orotracheal intubation, immediate complications after intubation, mortality and in-hospital complications.

Description:

High-flow Nasal Catheter (HFNC) compared to oxygenation conventional during the perioperative period of patients undergoing thoracic surgery The increase in surgeries performed worldwide, with today an estimate of more than 300 million surgeries/year, makes us increasingly need knowledge and strategies to improve perioperative care. Complications in this period are responsible for an increase in morbidity and mortality of patients, reducing the effectiveness of the surgical treatment, mainly in developing countries. The use of a nasal cannula high-flow (HFNC) oxygen during the perioperative period offers a promising technique to improve the lung function of these patients, enabling better outcomes. The purpose of this study, therefore, is to clarify whether there is benefit from the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications. Primary and secondary objectives Main goal - To evaluate the incidence of in-hospital pulmonary complications in 30 days in participants submitted to the use of HFNC in the perioperative period of participants undergoing thoracic surgery, when compared to the use of conventional oxygen therapy. - To evaluate in-hospital postoperative mortality within 30 days. Secondary objectives - Assess the incidence of hypoxemia during orotracheal intubation and extubation - Assess the incidence of immediate complications after intubation and extubation (desaturation, failure of intubation/ extubation) It will be a randomized, non-blinded, single-center clinical trial. Participants (older than 18 years old) who undergo thoracic surgery and who are at surgical risk for postoperative complications with ARISCAT > 26 (risk score for pulmonary complications) will be allocated consecutively and randomized to participate in the intervention group or control, receiving written informed consent to the study and interventions. The study will be carried out at Hospital Tacchini, from July 2023 to June 2024. Control group will receive conventional oxygen therapy, and the intervention group will receive HFNC therapy at induction of anesthesia and postoperatively, after extubation. Oxygenation will be performed, according to the randomization, in the control group, by mask facial, with 100% oxygen and flow of 10 L.min-1. The intervention group will receive oxygenby 100% HFNC with a flow of 40 L.min-1 being increased to 70 L.min-1 during the periodof apnea. A rapid sequence of orotracheal intubation will be performed, considering the time of apnea the moment of disappearance of the capnography line until the first ventilation after tube placement. Difficulties and complications in carrying out this step will be described. A oxygen saturation will be measured before the start of pre-oxygenation and will be considered hypoxemia, any measurement below 90% saturation, during the initiation of the rapid sequence intubation up to 5 minutes after it, in both groups. All participants will be intubated according to current orotracheal intubation guidelines. After surgery, participants who are extubated in the operating room or in the intensive care unit, will remain in the control and intervention groups and will receive therapy for conventional oxygen or HFNC, respectively. The fraction of inspired oxygen (FiO2) will be titrated until pulse oximetry is above 95%, which is also reduced to the level minimum, to achieve this objective. In the control group, oxygen will be offered through a nasal catheter or face mask and those in the intervention group will receive oxygen through HFNC with flows adjusted between 30 and 50 L.min-1, depending on the respiratory rate (less than 16) and the patient comfort. Data and statistics analysis strategy The data, after being collected, will be expressed as mean and standard deviation or absolute frequency and relative. Data normality will be tested by the Kolmogorov-Smirnov test. The difference Significant difference between groups will be analyzed using Student's t test for data for parametric data and for non-parametric data the Wilcoxon test will be used. The program used will be the Statistical Package for the Social Sciences, version 20 (SPSS Inc., Chicago, IL,USA) and the significance level adopted will be p<0.05. Calculation and/or justification of the sample size According to the literature, patients undergoing thoracic surgery may present severe complications such as postoperative hypoxemia in up to 30% of cases, after extubation. Based on the literature review, the sample calculation should be 45 patients for each group. For the sample calculation, we considered the value of β of 20% and α of 5%. . Using a effect size (calculated from the article data) of 0.6, a statistical power of 80% and a significance level of p<0.05 (or 5%), the investigators obtained as a result the n of 90 volunteers per group (final sample, excluding possible losses). The G*Power program version 3.1.9.2 for Windows (Franz Faul, University Kiel, Germany) was used to perform the calculation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients over 18 years of age who will undergo elective thoracic surgery and who have an ARISCAT score > 26.

Exclusion Criteria:

• Patients who need urgent/emergency surgery, pregnant women, who do not have an ARISCAT score > 26 and those who refuse to participate in the study.

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

Device:
• high flow nasal cannula
The purpose of this intervention is clarify the benefit with the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications. is to clarify whether there is benefit from the perioperative use of HFNC, in thoracic surgeries, from intubation to the postoperative period, evaluating mortality and in-hospital complications.

Locations

Country	Name	City	State
Brazil	Desejo Tarso Maioli	Bento Gonçalves	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (24)

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Fraser JF, Spooner AJ, Dunster KR, Anstey CM, Corley A. Nasal high flow oxygen therapy in patients with COPD reduces respiratory rate and tissue carbon dioxide while increasing tidal and end-expiratory lung volumes: a randomised crossover trial. Thorax. 2016 Aug;71(8):759-61. doi: 10.1136/thoraxjnl-2015-207962. Epub 2016 Mar 25. — View Citation

Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194. Erratum In: JAMA. 2016 Nov 15;316(19):2047-2048. JAMA. 2017 Feb 28;317(8):858. — View Citation

Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711. — View Citation

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Papazian L, Corley A, Hess D, Fraser JF, Frat JP, Guitton C, Jaber S, Maggiore SM, Nava S, Rello J, Ricard JD, Stephan F, Trisolini R, Azoulay E. Use of high-flow nasal cannula oxygenation in ICU adults: a narrative review. Intensive Care Med. 2016 Sep;42(9):1336-49. doi: 10.1007/s00134-016-4277-8. Epub 2016 Mar 11. — View Citation

Pennisi MA, Bello G, Congedo MT, Montini L, Nachira D, Ferretti GM, Meacci E, Gualtieri E, De Pascale G, Grieco DL, Margaritora S, Antonelli M. Early nasal high-flow versus Venturi mask oxygen therapy after lung resection: a randomized trial. Crit Care. 2019 Feb 28;23(1):68. doi: 10.1186/s13054-019-2361-5. — View Citation

Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19. — View Citation

Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Moine P, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network investigators. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014 Dec;2(12):1007-15. doi: 10.1016/S2213-2600(14)70228-0. Epub 2014 Nov 13. Erratum In: Lancet Respir Med. 2014 Dec;2(12):e23. — View Citation

Sklar MC, Dres M, Rittayamai N, West B, Grieco DL, Telias I, Junhasavasdikul D, Rauseo M, Pham T, Madotto F, Campbell C, Tullis E, Brochard L. High-flow nasal oxygen versus noninvasive ventilation in adult patients with cystic fibrosis: a randomized crossover physiological study. Ann Intensive Care. 2018 Sep 5;8(1):85. doi: 10.1186/s13613-018-0432-4. — View Citation

Spence EA, Rajaleelan W, Wong J, Chung F, Wong DT. The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis. Anesth Analg. 2020 Oct;131(4):1102-1110. doi: 10.1213/ANE.0000000000005073. — View Citation

Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213. — View Citation

Vourc'h M, Nicolet J, Volteau C, Caubert L, Chabbert C, Lepoivre T, Senage T, Roussel JC, Rozec B. High-Flow Therapy by Nasal Cannulae Versus High-Flow Face Mask in Severe Hypoxemia After Cardiac Surgery: A Single-Center Randomized Controlled Study-The HEART FLOW Study. J Cardiothorac Vasc Anesth. 2020 Jan;34(1):157-165. doi: 10.1053/j.jvca.2019.05.039. Epub 2019 May 29. — View Citation

Wittenstein J, Ball L, Pelosi P, Gama de Abreu M. High-flow nasal cannula oxygen therapy in patients undergoing thoracic surgery: current evidence and practice. Curr Opin Anaesthesiol. 2019 Feb;32(1):44-49. doi: 10.1097/ACO.0000000000000682. — View Citation

Wu X, Cao W, Zhang B, Wang S. Effect of high-flow nasal cannula oxygen therapy vs conventional oxygen therapy on adult postcardiothoracic operation: A meta-analysis. Medicine (Baltimore). 2018 Oct;97(41):e12783. doi: 10.1097/MD.0000000000012783. — View Citation

Yu Y, Qian X, Liu C, Zhu C. Effect of High-Flow Nasal Cannula versus Conventional Oxygen Therapy for Patients with Thoracoscopic Lobectomy after Extubation. Can Respir J. 2017;2017:7894631. doi: 10.1155/2017/7894631. Epub 2017 Feb 19. — View Citation

Zochios V, Collier T, Blaudszun G, Butchart A, Earwaker M, Jones N, Klein AA. The effect of high-flow nasal oxygen on hospital length of stay in cardiac surgical patients at high risk for respiratory complications: a randomised controlled trial. Anaesthesia. 2018 Dec;73(12):1478-1488. doi: 10.1111/anae.14345. Epub 2018 Jul 18. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Complications	To evaluate the incidence of in-hospital pulmonary complications in 30 days in patients submitted to the use of HFNC in the perioperative period of patients undergoing thoracic surgery, when compared to the use of conventional oxygen therapy. extubation	30 days
Primary	Mortality	To evaluate in-hospital postoperative mortality within 30 days.	30 days
Secondary	Incidence of hipoxemia	- Assess the incidence of hypoxemia during orotracheal intubation and extubation.	5 minuts
Secondary	Complications after intubation and extubation	Assess the incidence of immediate complications after intubation and extubation (desaturation, failure of intubation and extubation)	5 minuts