Viewing Study NCT05910788



Ignite Creation Date: 2024-05-06 @ 7:09 PM
Last Modification Date: 2024-10-26 @ 3:01 PM
Study NCT ID: NCT05910788
Status: RECRUITING
Last Update Posted: 2023-08-01
First Post: 2023-05-29

Brief Title: High-Flow Nasal Catheter HFNC Compared With Conventional Oxygenation
Sponsor: Federal University of Rio Grande do Sul
Organization: Federal University of Rio Grande do Sul

Study Overview

Official Title: High-Flow Nasal Catheter HFNC Compared With Conventional Oxygenation During the Perioperative Period of Patients Undergoing Thoracic Surgery
Status: RECRUITING
Status Verified Date: 2023-07
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: 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
Detailed 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 surgeriesyear 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 Lmin-1 The intervention group will receive oxygenby 100 HFNC with a flow of 40 Lmin-1 being increased to 70 Lmin-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 Lmin-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 Students 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 ILUSA and the significance level adopted will be p005

Calculation andor 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 06 a statistical power of 80 and a significance level of p005 or 5 the investigators obtained as a result the n of 90 volunteers per group final sample excluding possible losses The GPower program version 3192 for Windows Franz Faul University Kiel Germany was used to perform the calculation

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