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OpenTrials
Completed

NCT Number: NCT03237806

Effects of Sedation on Transpulmonary Pressure and Lung Homogenous

The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near diaphram during mechanical ventilation, however, strong respiratory drive could generate more transpulmonary pressure in ARDS patients, which increase the stress and strain in injured lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of ARDS patients.The purpose of this study is to investigate the effects of sedation on transpulmonary pressure of ARDS patients.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

About this study

Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast University

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:
  • Requires positive pressure ventilation through an endotracheal tube
  • Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
  • PaO2/FiO2 less than 300 while receiving positive end-expiratory pressure (PEEP) at more than 5 cm H2O for at least 4 hours, with a duration of no more than 7 days
  • No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)
  • Surgical patient Surgical patient requires positive pressure ventilation through an endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)

Exclusion criteria

  • Age younger than 18 years or older than 85 years
  • Cardiac failure
  • Known pregnancy
  • Increased intracranial pressure
  • Severe neuromuscular disease
  • Recent injury or other pathologic condition of the esophagus
  • Pneumothorax
  • Pleural effusion
  • Diaphragmatic hernia
  • Severe chronic respiratory disease
  • End-stage chronic organ failure
  • Expected survival of less than 24 hours
  • Participation in another interventional study
  • Attending physician declines to give consent for participant to enroll
  • Patient or surrogate declines or is unable to give consent

Treatment and study plan

Deep sedated

Drug

Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)

Other names: Deep sedation

Light sedated

Drug

Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)

Other names: Light sedation

Primary outcomes

  1. Transpulmonary pressure generate by patient during deep or light sedation

    Time frame: 15 minutes during deep or light sedation

    Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation

Secondary outcomes

  1. static compliance of respiratory system

    Time frame: 15min during deep or light sedation

    Crs measured during deep or light sedation

  2. PaO2

    Time frame: 15 minutes

    ABG after deep or light sedation

Other outcomes

  1. MAP

    Time frame: 15 minutes

    MAP during deep or light sedation

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Effects of Sedation on Transpulmonary Pressure and Lung Homogenous of ARDS Patients

Acronym: ARDS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2017
Registry last updated
Mar 20, 2018

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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