Effects of Sedation on Transpulmonary Pressure and Lung Homogenous

NCT03237806 | Completed DMC

• 1 other identifier: 2012ZDIIKY22.0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS

Keywords

ARDS,; Transpulmonary pressure,; Sedation

Outcome Measures

Primary Outcomes (1)

• Transpulmonary pressure generate by patient during deep or light sedation

  Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation

  15 minutes during deep or light sedation

Secondary Outcomes (2)

• static compliance of respiratory system

  15min during deep or light sedation

• PaO2

  15 minutes

Other Outcomes (1)

• MAP

  15 minutes

Study Arms (3)

Baseline

NO INTERVENTION

In this phase, patients were sedated to the level of Ramsay 6 before Deep sedated or Light sedated

Deep sedation

EXPERIMENTAL

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

Drug: Deep sedated

Light sedation

EXPERIMENTAL

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

Drug: Light sedated

Interventions

Deep sedated DRUG

Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)

Also known as: Deep sedation

Deep sedation

Light sedated DRUG

Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)

Also known as: Light sedation

Light sedation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Interventions

Deep Sedation

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Songqiao Liu, Doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Self control

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: August 3, 2017
• Study Start: May 31, 2015
• Primary Completion: January 18, 2018
• Study Completion: March 18, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)