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The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia

Recruiting
Conditions
Severe Pneumonia
Registration Number
NCT06514781
Lead Sponsor
Xiangya Hospital of 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
600
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mechanical ventilation duration2024.01-2024.12

It is defined as the time from intubation (for patients intubated after ICU admission) or ICU admission (for patients already intubated upon ICU admission) to extubation

Secondary Outcome Measures
NameTimeMethod
The patient's sedation success rate2024.01-2024.12

The level of sedation was assessed using the Richmond Agitation-Sedation Scale (RASS). Successful sedation was defined by meeting both of the following criteria: a) the proportion of time during the study medication period that the RASS score was between +1 and -2 was ≥ 70.0%; b) no rescue therapy was used.

Trial Locations

Locations (1)

Xiangya Hospital Central South University

🇨🇳

Changsha, Hunan, China

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