Timings for Awake Prone Positioning in Covid-19 Patients : Timings for Awake Prone Positioning in Covid-19 Patients

Setting and designRetrospectively collect relevant data from the electronic medical records of COVID-19 patients who were admitted to the research center from December 2022 to February 2023.Study ParticipantsConvenient sampling of COVID-19 patients admitted to the research center from December 2022 to February 2023.Inclusion criteria:age 18 years or older;laboratory-confirmed COVID-19 patients;radiographic evidence of pulmonary inflammation;clear consciousness and ability to communicate verbally;patients who have undergone prone position ventilation at least once during hospitalization;Exclusion criteria:• patients who received mechanical ventilation and oral intubation immediately after admission or within 2 hours of admission.Sample Size Determination Sample size of the multivariable Cox regression model for patients' overall survival is calculated by using the previously reported method. Based on the generally accepted rule of thumb of 10 events per variable and the final Cox model containing 4 variables, the field size was expected to be 40 events. A sample size of at least 440 patients are warranted based on an estimated 10% event rate and a 10% loss to-review rate among the participants.Data collection4.1 Baseline data: Gender, age, comorbidities, body mass index (BMI), smoking status, use of anti-Covid-19 drugs (Paxlovid and Azvudine), use of corticosteroids, and radiological results, etc., as baseline and demographic data.4.2 Data related to awake prone positioning: Time from admission to first use of awake prone positioning, oxygen delivery method and oxygen concentration at first use of awake prone positioning, peripheral oxygen saturation during use of awake prone positioning, systolic blood pressure and respiratory rate at first use of awake prone positioning, duration of daily use of awake prone positioning, total number of days using awake prone positioning, achievement of awake prone positioning goals, acceptance of maintenance measures for awake prone positioning, changes in oxygen delivery method and oxygen concentration after first use of awake prone positioning, and adverse events caused by awake prone positioning (dislodged catheter, skin injury, and gastrointestinal reactions).4.3 primary outcome: Mortality rate.4.4 Secondary outcomes: Intubation, upgrading of oxygen supply equipment, deterioration of respiratory failure, and length of hospital stay.Data collection and management Data is collected through the hospital's electronic medical record management system and recorded in the original registration log. All data is recorded clearly to ensure accurate interpretation and traceability. All data and original documents are kept for a minimum of 3 years, and publication and data sharing agreements are made.Statistical Analysis Quantitative variables will be described using means (standard deviations) or medians [interquartile ranges], while categorical variables will be described using counts (proportions). We will use t-tests to compare normally distributed variables and chi-square tests to compare proportions. For non-normally distributed variables, we will use the Mann-Whitney U test. We will examine the predictive ability of SPO2:FIO2 for various respiratory outcomes and mortality rates by calculating the area under the receiver operating characteristic curve and the Youden index and explore the optimal discriminating threshold. We will then divide study subjects into low and high SPO2:FIO2 groups based on the threshold and compare their characteristics in univariate analysis. In addition, we will compare characteristics of patients with and without adverse respiratory outcomes in univariate analysis. We will further investigate the relationship between adverse respiratory outcomes occurring within 28 days and variables with P values <0.10 in univariate analysis using Cox proportional hazards regression models to analyze the relationship between the time to occurrence of adverse respiratory outcomes (up to 28 days) and these variables. The same methods will be used to explore the relationship between these variables and 28-day hospital mortality rate. We will also use Kaplan-Meier curves to plot the percentage of Covid-19 patients who experience adverse respiratory outcomes or die within 28 hospital days based on the SpO2/FiO2 ratio at first application of awake prone positioning, controlling for these covariates through Cox regression. A significance level of 0.05 will be used for all two-tailed tests. Data will be analyzed using SPSS 26.0.Quality Control7.1 Establish a unified case information collection register. Before collecting data, all data collectors will receive unified training to clarify the concept of data collection and screening standards, ensuring the consistency of data collection.7.2 Data collection will be carried out simultaneously by two individuals and entered into the electronic medical record information collection register to ensure accuracy.7.3 If any unresolved or uncertain issues arise during the data collection process, timely communication with the principal investigator will be conducted to ensure consistency of the information..

Medienart:	Klinische Studie

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	ClinicalTrials.gov - (2023) vom: 30. Nov. Zur Gesamtaufnahme - year:2023

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Pneumonia Recruitment Status: Completed Study Type: Observational

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: April 3, 2023, Last downloaded: ClinicalTrials.gov processed this data on December 06, 2023, Last updated: December 06, 2023

Study ID:	NCT05795751 ZWQ21886
Veröffentlichungen zur Studie:

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PPN (Katalog-ID):	CTG009091955