Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
NCT Number: NCT06514781
This study collected data from patients with severe pneumonia to compare the duration of mechanical ventilation under different sedation regimens in real-world settings. It also evaluated and compared the sedation success rates, hemodynamic changes, and clinical outcomes of patients with severe pneumonia.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Changsha, Hunan, 410008, China
The study subjects were patients with severe pneumonia hospitalized in the Department of Respiratory and Critical Care Medicine at Xiangya Hospital, Central South University, from February 1, 2023 to December 31, 2024. Patients meeting all the following criteria were enrolled: (1) diagnosed with severe pneumonia; (2) receiving invasive mechanical ventilation and requiring continuous sedation treatment; (3) age ≥ 18 years. Patients were excluded if they met any of the following conditions: (1) allergic to routine sedative or analgesic medications; (2) had not undergone sedation-agitation assessment; (3) transferred to another hospital during treatment; (4) withdrew from active treatment or were discharged from the ICU within 72 hours after initiation of sedation. Data on patient demographics, laboratory tests, chest imaging, respiratory support methods, severity of illness assessments, sedative medication usage, and clinical outcomes were collected. The duration of mechanical ventilation under different sedation regimens in real-world settings was compared, and the correlation between sedation success rates, hemodynamic changes, and clinical outcomes in patients with severe pneumonia was evaluated and compared.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(1)From February 1, 2023, to December 31, 2024, diagnosed with severe pneumonia in the Respiratory Intensive Care Unit of Xiangya Hospital, Central South University. The diagnosis of severe pneumonia is based on meeting at least one major criterion or three or more minor criteria:
①Infectious shock requiring vasopressor therapy despite adequate fluid resuscitation;
②Respiratory failure requiring tracheal intubation or mechanical ventilation.
⑥Systolic blood pressure < 90 mmHg requiring aggressive fluid resuscitation. (2)Patients receiving invasive mechanical ventilation who require continuous sedation treatment.
(3)Age ≥ 18 years.
Exclusion criteria
Time frame: From intubation (or ICU admission for patients already intubated at ICU admission) until extubation or death, whichever occurs first, assessed up to 90 days.
It was defined as the time from intubation (for patients intubated after ICU admission) or ICU admission (for patients already intubated upon ICU admission) to extubation or death, whichever occurred first.
Time frame: During the continuous sedation treatment period, from the initiation to the discontinuation of continuous sedation, ICU discharge, or death (whichever comes first), assessed up to 90 days.
The level of sedation was assessed using the Richmond Agitation-Sedation Scale (RASS). Successful sedation was defined as the rate of achieving the target sedation level of Richmond Agitation-Sedation Scale [RASS]- 1 to - 4 in more than 90% of recorded RASS assessments.
Time frame: From ICU admission up to ICU discharge or death.
The total number of days from ICU admission to ICU discharge. For patients who die in the ICU, the length of stay is calculated as the date of death minus the date of ICU admission.
Time frame: From ICU admission through day 28.
The proportion of patients alive at 28 days after ICU admission. Vital status was assessed 28 days after ICU admission.
Time frame: During the on-treatment period, defined as from first dose to 7 days after last dose.
The incidence of circulatory adverse events, including hypotension (systolic blood pressure [SBP] <90 mmHg, diastolic blood pressure [DBP] <60 mmHg, mean arterial pressure [MAP] <70 mmHg, or a >30% decrease from baseline) and bradycardia (heart rate [HR] <40 bpm or a >30% decrease from baseline). Exploratory safety analyses include the total duration of vasoactive drug use (h) and the cumulative dose of vasoactive drugs (mg).
Looking for future studies?
Notify MeXiangya Hospital of Central South University
Other
Acronym: ICU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03831906
Actinomycetales Infections, Bacterial Infections
Kampong Cham, Cambodia
View Trial DetailsNCT07149909
Critical Illness, Cross Infection
Banhā, Benha, Egypt
View Trial DetailsNCT07112976
Infections, Lung Diseases
Milan, Italy
View Trial DetailsNCT05663905
Community-Acquired Infections, Community-Acquired Pneumonia
Cheras, Kuala Lumpur, Malaysia
View Trial Details