Inhomogeneous Ventilation in Adult Post-neurosurgical Patients

NCT03830099 | Unknown DMC

• 1 other identifier: KY 2018-006-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mechanical Ventilation; Electrical Impedance Tomography; Inhomogeneous Ventilation; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The incidence of postoperative pulmonary complications(PPCs)

  28 days after neurosurgical operative

• Length of ICU stay

  through study completion, an average of 7 days

• Length of hospital stay

  through study completion, an average of 28 days

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender was based on basic information collected at the moment when patients was admitted to hospital.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult post-neurosurgical patients under mechanical ventilation(MV).

You may qualify if:

• Undergoing elective neurosurgery operation
• Trachea intubated and mechanical ventilated

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Study Officials

• Jian-Xin Zhou, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

8610 67096579; zhoujx.cn@icloud.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 5, 2019
• Study Start: April 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: August 31, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

CN (1)