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Post-neurosurgical Respiratory Muscle Dysfunction

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05951114
Enrollment
100
Registered
2023-07-18
Start date
2023-07-01
Completion date
2025-03-01
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Issues, Neurosurgery, Pulmonary Complication

Keywords

Neurosurgery, Respiratory muscle dysfunction, Diaphragm, Expiratory muscle, Post operative pulmonary complications

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.

Interventions

DIAGNOSTIC_TESTMaximum inspiratory/Expiratory manoeuvre for patients can follow the order

Bedside ultrasound will be performed for each patient at the time before, after surgery, before and after extubation, and at the time of ICU discharge, under the end-expiratory occlusion, maximum inspiratory, and/or expiratory manoeuvre

Sponsors

Beijing Sanbo Brain Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Informed consent * First elective operation during hospitalization * ASA\<3

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of diaphragm dysfunction after neurosurgeryWithin 24 hours after the completion of surgeryThe diaphragm dysfunction is defined as the thickening fraction \< 20% under the maximum inspiration

Secondary

MeasureTime frameDescription
The correlation between the level of inflammation maker ILs and the diaphragm functionWithin 24 hours after the completion of surgeryThe level of ILs are measured in the blood sample within 24 hours after surgery
The correlation between the level of inflammation maker TNF-alpha and the diaphragm functionWithin 24 hours after the completion of surgeryThe level of TNF-alpha is measured in the blood sample within 24 hours after surgery
The thickening fraction of expiratory muscles after surgeryWithin 24 hours after the completion of surgerythe thickening fraction of expiratory muscle is measured under the maximum expiration maneuver
The incidence of postoperative pulmonary complicationThrough study completion, an average of 1 monthThe postoperative pulmonary complication is defined as when patient has developed one or more complications including pneumonia, atelectasis, pulmonary edema, pulmonary embolism, or respiratory failure
The correlation between the level of NSE and the diaphragm functionWithin 24 hours after the completion of surgeryThe level of NSE is measured in the blood sample within 24 hours after surgery
The length of ICU stayThrough study completion, an average of 1 monthThe length of ICU stay is counted by day
Duration of mechanical ventilationThrough study completion, an average of 1 monthThe duration of mechanical ventilation is counted by hours
Hospital mortalityThrough study completion, an average of 1 monthThe hospital mortality is recorded at the time of discharge
The length of hospital stayThrough study completion, an average of 1 monthThe length of hospital stay is counted by day

Countries

China

Contacts

Primary ContactZhonghua Shi, PhD
z.shi@mail.ccmu.edu.cn62856764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026