NCT03096106

Brief Summary

Airway pressure-time (P-t) curve and stress index (SI) assessment have been proposed to guide the mechanical ventilation settings and minimize ventilator-induced lung injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 7, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

March 16, 2017

Last Update Submit

August 3, 2017

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • the types of pressure time curve by visual inspection.

    the pressure time curves have the three types:the straight,concave,convex,the observers will judge the types of pressure time curve by visual inspection, and record the results of judgement

    up to 10min, from the ventilator screen being frozen to the two observers completing judgement.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

intubated and mechanical ventilated by volume-control ventilation with constant flow

You may qualify if:

  • aged 18 years or older; intubated and mechanical ventilated by volume-control ventilation with constant flow;

You may not qualify if:

  • evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube; evidence of the stiff chest wall, such as existing the pleural effusion, intra abdominal hypertension, chest injuries and abdominal injuries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

  • Sun XM, Chen GQ, Chen K, Wang YM, He X, Huang HW, Luo XY, Wang CM, Shi ZH, Xu M, Chen L, Fan E, Zhou JX. Stress Index Can Be Accurately and Reliably Assessed by Visually Inspecting Ventilator Waveforms. Respir Care. 2018 Sep;63(9):1094-1101. doi: 10.4187/respcare.06151. Epub 2018 Jun 26.

    PMID: 29945907DERIVED

Study Officials

  • Jian-xin zhou

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 30, 2017

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)