Effects of Sedation on Transpulmonary Pressure and Lung H... | NCT03237806

Studies
Effects of Sedation on Transpulmonary Pressure and Lung Homogenous

NCT03237806

Sponsor

Southeast University, China

Status

Completed

Last Update Posted

Mar 20, 2018Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

ARDS

Interventions

Deep sedated
Light sedated

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2015Actual

Primary Completion Date

Jan 18, 2018Actual

Completion Date

Mar 18, 2018Actual

First Submitted Date

May 21, 2014

First Submission Date that Met QC Criteria

Jul 30, 2017

First Posted Date

Aug 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2018

Last Update Posted Date

Mar 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Deep sedated	Drug	Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)	Deep sedation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
static compliance of respiratory system	Crs measured during deep or light sedation	15min during deep or light sedation
PaO2	ABG after deep or light sedation

Other Outcomes

Measure	Description	Time Frame
MAP	MAP during deep or light sedation	15 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:
1. Requires positive pressure ventilation through an endotracheal tube
2. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
3. 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
4. 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Songqiao Liu, Doctor	Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University		Nanjing	Jiangsu	210009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided