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NCT Number: NCT06514781

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location status: Recruiting

Location contact

Yuanyuan Li, Doctor

CONTACT

[email protected]

13975806790

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Mechanical ventilation duration

    Time frame: 2024.01-2024.12

    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 outcomes

  1. The patient's sedation success rate

    Time frame: 2024.01-2024.12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanyuan Li, Doctor

CONTACT

[email protected]

13975806790

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Acronym: ICU

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

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.

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