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Clinical Trials/NCT05951114
NCT05951114
Recruiting
Not Applicable

The Development of Post-operative Respiratory Muscle Dysfunction in Neurosurgical Patients

Beijing Sanbo Brain Hospital1 site in 1 country100 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diaphragm Issues
Sponsor
Beijing Sanbo Brain Hospital
Enrollment
100
Locations
1
Primary Endpoint
Incidence of diaphragm dysfunction after neurosurgery
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Respiratory muscle dysfunction may contribute to the development of postoperative pulmonary complications. However, it prevalence in patients receiving neurosurgery is largely unknown. Therefore, in present study, respiratory muscle function (measured by the ultrasound) and their correlation with the post-operative pulmonary complications will be analyzed.

Detailed Description

Postoperative pulmonary complications is common in patients receiving neurosurgery, and is associated with hospitalization cost and mortality. Respiratory muscle dysfunction is an important cause postoperative pulmonary complications, however, it's prevalence in patients receiving neurosurgery is unclear. The diaphragm and abdominal expiratory muscles are the main inspiratory and expiratory driving muscles. Ultrasound can assess the function and morphology of these muscles invasively and in realtime. Studies has demonstrated their feasibility and repeatability in realtime monitoring of respiratory muscles. In this study, our primary aim is to assess the respiratory muscle function after neurosurgery, and the correlation between diaphragm and expiratory muscle function. Our secondary aims including the correlation between the brain injury and the respiratory muscle function, and the impact of post-operative respiratory muscle dysfunction on the pulmonary complications.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
March 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Sanbo Brain Hospital
Responsible Party
Principal Investigator
Principal Investigator

Zhonghua Shi, MD, PhD

Deputy president of the department ICU

Beijing Sanbo Brain Hospital

Eligibility Criteria

Inclusion Criteria

  • Informed consent
  • First elective operation during hospitalization

Exclusion Criteria

  • Brain stem and spinal spine lesions
  • Preoperative chest imaging findings were abnormal
  • Mechanical ventilation was required before surgery
  • Clinical or radiological evidence of preoperative misaspiration
  • History of neurosurgery in the last 6 months
  • A history of neuromuscular disease
  • BMI≥35kg/m2
  • Pregnant women
  • Skin lesions detected by ultrasound

Outcomes

Primary Outcomes

Incidence of diaphragm dysfunction after neurosurgery

Time Frame: Within 24 hours after the completion of surgery

The diaphragm dysfunction is defined as the thickening fraction \< 20% under the maximum inspiration

Secondary Outcomes

  • The correlation between the level of inflammation maker ILs and the diaphragm function(Within 24 hours after the completion of surgery)
  • The thickening fraction of expiratory muscles after surgery(Within 24 hours after the completion of surgery)
  • The length of ICU stay(Through study completion, an average of 1 month)
  • The correlation between the level of NSE and the diaphragm function(Within 24 hours after the completion of surgery)
  • The incidence of postoperative pulmonary complication(Through study completion, an average of 1 month)
  • Hospital mortality(Through study completion, an average of 1 month)
  • The length of hospital stay(Through study completion, an average of 1 month)
  • Duration of mechanical ventilation(Through study completion, an average of 1 month)
  • The correlation between the level of inflammation maker TNF-alpha and the diaphragm function(Within 24 hours after the completion of surgery)

Study Sites (1)

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