Inhomogeneous Ventilation in Adult Post-neurosurgical Patients

Mechanical Ventilation Clinical Trial

Official title:

Inhomogeneous Ventilation in Adult Post-neurosurgical Patients: an Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03830099
• Other study ID #: KY 2018-006-01
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: February 2019
• Source: Capital Medical University
• Contact: Jian-Xin Zhou, MD
• Phone: 8610 67096579
• Email: zhoujx.cn[@]icloud.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Inhomogeneous ventilation was more likely to happen in patients after general anesthesia. Inhomogeneous ventilation may associate with ventilator-induced lung injury. A large number of post-neurosurgical patients was delayed extubation and received mechanical ventilation, so that, inhomogeneous ventilation was more likely to happen in the population. Electrical impedance tomography (EIT) is an noninvasive, radiation-free, high temporal resolution, relatively cheap technique in monitoring ventilation distribution bedside. The investigators aimed to investigate the incidence of inhomogeneous ventilation and factors associated with inhomogeneous ventilation in post-neurosurgical patients under mechanical ventilation.

Description:

Inhomogeneous ventilation was more likely to happen in patients after general anesthesia. Inhomogeneous ventilation may associate with ventilator-induced lung injury since the gravity-depend collapse and over-distention of nondependent regional in patients under mechanical ventilation. A large number of post-neurosurgical patients was delayed extubation and received mechanical ventilation, so that, inhomogeneous ventilation was more likely to happen in the population. Up to now, there is no research reported about the prevalence of inhomogeneous ventilation and the factors associated with inhomogeneous ventilation in post-neurosurgical patients, in present study, The investigators prospectively enrolled adult patients after neurosurgical operations. Electrical impedance tomography (EIT) is an noninvasive, radiation-free, high temporal resolution, relatively cheap technique in monitoring ventilation distribution bedside. The investigators aimed to investigate the incidence of inhomogeneous ventilation and factors associated with inhomogeneous ventilation in post-neurosurgical patients under mechanical ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing elective neurosurgery operation

• Trachea intubated and mechanical ventilated

Exclusion Criteria:

• Age under 18 years-old

• Unstable hemodynamics patients (mean arterial pressure under 65mmHg) after pharmacotherapy

• History of chronic obstructive pulmonary disease(COPD) or asthma

• Contraindication of using EIT (pacemaker, defibrillator, and implantable pumps)

• Unable to install EIT belt (skin infection, wound)

• Incompleteness of thorax (e.g. pneumothorax, rib fracture and etc.) or malformation of thorax.

Related Conditions & MeSH terms

• Electrical Impedance Tomography
• Inhomogeneous Ventilation
• Mechanical Ventilation
• Neurosurgery

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	Incidence of inhomogeneous ventilation	In supine position, global image of EIT was divided into upper and lower part, each part accounting for 50%, which was named as non-dependent region and dependent region respectively. Inhomogeneous ventilation was defined as the ratio between tidal impedance variation of dependent region(VTdep) and global tidal impedance variation (VT) is less than 45% during stable Spontaneous breath, which was defined as variation of tidal volume less than 10% in continuous 6 breathes.	within 24 hours after neurosurgical operative
Secondary	The incidence of postoperative pulmonary complications(PPCs)	Postoperative pulmonary complication was defined as follows: Pneumonia was defined as recent pulmonary infiltration on chest radiography associated with at least 2 of the following signs: purulent tracheobronchial secretion, a body temperature > 38.3?,and leukocytes in peripheral blood > 25% above the basal count. Tracheobronchitis was an increase in the volume or a change in the color or purulent aspect of tracheobronchial secretion with a normal chest radiograph. Atelectasis was evidence on chest radiography of pulmonary atelectasis associated with acute respiratory symptoms. Bronchoconstriction was classified as the presence of wheezing associated with acute respiratory symptoms with a good response to inhalatory bronchodilator medication.	28 days after neurosurgical operative
Secondary	Length of ICU stay	The number of days that patients stay in ICU.	through study completion, an average of 7 days
Secondary	Length of hospital stay	The number of days that patients stay in hospital.	through study completion, an average of 28 days