Visual Assessment for Pressure-time Curve

Mechanical Ventilation Clinical Trial

Official title:

The Reliability and Validity of Visual Assessment for Pressure-time Curve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096106
• Other study ID #: KY2017-016-02
• Status: Completed
• Phase: N/A
• First received: March 16, 2017
• Last updated: August 3, 2017
• Start date: December 1, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: March 2017
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The stress index (SI), which has been proposed to guide the mechanical ventilation settings and minimize ventilator-induced lung injury. It reflects the change of respiratory compliance during inspiration. Value of SI equals to 1 that indicates a constant compliance, whereas values lower and higher than 1 indicate increase and decrease of compliance over inspiratory time, suggesting tidal recruitment and tidal hyperinflation, respectively. Based on the different values of SI showing different shapes, SI of straight curve equals to 1, SI of concave curve lower than 1 and convex curve higher than 1, the investigators speculated that the SI value could be reliably and accurately estimated by visual inspection of the P-t curve.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Mechanical Ventilation

Locations

Country	Name	City	State
China	ICU, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.