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Completed

NCT Number: NCT06514781

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

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.

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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

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 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.

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 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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Sedation success rate

    Time frame: 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.

    The level of sedation was assessed using the Richmond Agitation-Sedation Scale (RASS). Successful sedation was defined as the rate of achieving the target sedation level of Richmond Agitation-Sedation Scale [RASS]- 1 to - 4 in more than 90% of recorded RASS assessments.

  2. Length of ICU Stay

    Time frame: From ICU admission up to ICU discharge or death.

    The total number of days from ICU admission to ICU discharge. For patients who die in the ICU, the length of stay is calculated as the date of death minus the date of ICU admission.

  3. 28-Day Survival Rate

    Time frame: From ICU admission through day 28.

    The proportion of patients alive at 28 days after ICU admission. Vital status was assessed 28 days after ICU admission.

Other outcomes

  1. Safety endpoints

    Time frame: During the on-treatment period, defined as from first dose to 7 days after last dose.

    The incidence of circulatory adverse events, including hypotension (systolic blood pressure [SBP] <90 mmHg, diastolic blood pressure [DBP] <60 mmHg, mean arterial pressure [MAP] <70 mmHg, or a >30% decrease from baseline) and bradycardia (heart rate [HR] <40 bpm or a >30% decrease from baseline). Exploratory safety analyses include the total duration of vasoactive drug use (h) and the cumulative dose of vasoactive drugs (mg).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Acronym: ICU

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Sep 21, 2026

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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