The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Mechanical ventilation duration
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •Major criteria:
- •①Infectious shock requiring vasopressor therapy despite adequate fluid resuscitation;
- •②Respiratory failure requiring tracheal intubation or mechanical ventilation.
- •Minor criteria:
- •Respiratory rate ≥ 30 breaths/min;
- •Oxygenation index (PaO2/FiO2) ≤ 250; ③Involvement of multiple lobes;
- •Altered mental status and/or disorientation; ⑤Blood urea nitrogen ≥ 20 mg/dl (7.14 mmol/L);
- •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
- •Allergic to routine sedative or analgesic medications.
- •Patients who have not undergone sedation-agitation assessment.
- •Patients transferred to another hospital during treatment.
- •Patients who withdrew from active treatment or were discharged from the ICU within 72 hours after initiation of sedation.
Arms & Interventions
Cipepofol group
Initially use cipepofol as the sedative medication, with a continuous usage duration of more than 48 hours.
Conventional group
Initially use non-cipepofol sedative medications, with a continuous usage duration of more than 48 hours.
Outcomes
Primary Outcomes
Mechanical ventilation duration
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.
Secondary Outcomes
- Sedation success rate(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.)
- Length of ICU Stay(From ICU admission up to ICU discharge or death.)
- 28-Day Survival Rate(From ICU admission through day 28.)