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

NCT06514781 | Recruiting

• 1 other identifier: 2024020151
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Pneumonia

Keywords

Severe pneumonia; Sedative

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation duration

  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

  2024.01-2024.12

Secondary Outcomes (1)

• The patient's sedation success rate

  2024.01-2024.12

Study Arms (2)

Use cyclopofol group

Initially use propofol as the sedative medication, with a continuous usage duration of more than 48 hours.

Control group

Initially use non-propofol sedative medications, with a continuous usage duration of more than 48 hours.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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:
• 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; 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuanyuan Li, Doctor

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Central Study Contacts

Yuanyuan Li, Doctor

CONTACT

13975806790; Leeround@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CN (1)