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Clinical Trials/NCT03237806
NCT03237806
Completed
N/A

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

Southeast University, China1 site in 1 country24 target enrollmentMay 31, 2015

Overview

Phase
N/A
Intervention
Deep sedated
Conditions
ARDS
Sponsor
Southeast University, China
Enrollment
24
Locations
1
Primary Endpoint
Transpulmonary pressure generate by patient during deep or light sedation
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
May 31, 2015
End Date
March 18, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Southeast University, China
Responsible Party
Principal Investigator
Principal Investigator

Songqiao Liu

Principal Investigator

Southeast University, China

Eligibility Criteria

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

Arms & Interventions

Deep sedation

In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously

Intervention: Deep sedated

Light sedation

In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously

Intervention: Light sedated

Outcomes

Primary Outcomes

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

  • PaO2(15 minutes)
  • static compliance of respiratory system(15min during deep or light sedation)

Study Sites (1)

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