Clinical trial NCT06514781: The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia
Official title: The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Pneumonia
Keywords: Severe pneumonia
Sedative
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From February 1, 2023, to March 30, 2024, diagnosed with severe pneumonia in the Respiratory Intensive Care Unit of Xiangya Hospital, Central South University.

Brief summary: This study collected data from 600 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 January 2024 to December 2024. Patients meeting all the following criteria were enrolled: (1) diagnosed with severe pneumonia; (2) receiving mechanical ventilation and requiring 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 pain and sedation assessment; (3) transferred to another hospital during treatment; (4) abandoned treatment and were discharged within \<72 hours of treatment. 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.

Eligibility criteria: Inclusion Criteria:

(1)From February 1, 2023, to March 30, 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:

1. Major criteria:

   ①Infectious shock requiring vasopressor therapy despite adequate fluid resuscitation;②Respiratory failure requiring tracheal intubation or mechanical ventilation.
2. Minor criteria:

   * Respiratory rate ≥ 30 breaths/min; ②Oxygenation index (PaO2/FiO2) ≤ 250;

     * Involvement of multiple lobes; ④Altered 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 mechanical ventilation who require sedation treatment. (3)Age ≥ 18 years.

Exclusion Criteria:

1. Allergic to routine sedative or analgesic medications.
2. Patients who have not undergone pain and sedation assessment.
3. Patients transferred to another hospital during treatment.
4. Patients who abandon treatment and are discharged within less than 72 hours of treatment.

Primary outcomes:
measure: Mechanical ventilation duration
timeFrame: 2024.01-2024.12
Secondary outcomes:
measure: The patient's sedation success rate
timeFrame: 2024.01-2024.12
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Yuanyuan Li, Doctor
role: STUDY_DIRECTOR
References: