Post-neurosurgical Respiratory Muscle Dysfunction

Neurosurgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951114
• Other study ID #: HP2023-28-508001
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2024
• Source: Beijing Sanbo Brain Hospital
• Contact: Zhonghua Shi, PhD
• Phone: 62856764
• Email: z.shi[@]mail.ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm Issues
• Neurosurgery
• Pulmonary Complication

Intervention

Diagnostic Test:
• Maximum 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

Locations

Country	Name	City	State
China	Beijing Sanbo Brain Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Sanbo Brain Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Shi ZH, de Vries H, de Grooth HJ, Jonkman AH, Zhang Y, Haaksma M, van de Ven PM, de Man AAME, Girbes A, Tuinman PR, Zhou JX, Ottenheijm C, Heunks L. Changes in Respiratory Muscle Thickness during Mechanical Ventilation: Focus on Expiratory Muscles. Anesthesiology. 2021 May 1;134(5):748-759. doi: 10.1097/ALN.0000000000003736. — View Citation

Shi ZH, Jonkman A, de Vries H, Jansen D, Ottenheijm C, Girbes A, Spoelstra-de Man A, Zhou JX, Brochard L, Heunks L. Expiratory muscle dysfunction in critically ill patients: towards improved understanding. Intensive Care Med. 2019 Aug;45(8):1061-1071. doi: 10.1007/s00134-019-05664-4. Epub 2019 Jun 24. — View Citation

Tuinman PR, Jonkman AH, Dres M, Shi ZH, Goligher EC, Goffi A, de Korte C, Demoule A, Heunks L. Respiratory muscle ultrasonography: methodology, basic and advanced principles and clinical applications in ICU and ED patients-a narrative review. Intensive Care Med. 2020 Apr;46(4):594-605. doi: 10.1007/s00134-019-05892-8. Epub 2020 Jan 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of diaphragm dysfunction after neurosurgery	The diaphragm dysfunction is defined as the thickening fraction < 20% under the maximum inspiration	Within 24 hours after the completion of surgery
Secondary	The correlation between the level of NSE and the diaphragm function	The level of NSE is measured in the blood sample within 24 hours after surgery	Within 24 hours after the completion of surgery
Secondary	The correlation between the level of inflammation maker ILs and the diaphragm function	The level of ILs are measured in the blood sample within 24 hours after surgery	Within 24 hours after the completion of surgery
Secondary	The correlation between the level of inflammation maker TNF-alpha and the diaphragm function	The level of TNF-alpha is measured in the blood sample within 24 hours after surgery	Within 24 hours after the completion of surgery
Secondary	The thickening fraction of expiratory muscles after surgery	the thickening fraction of expiratory muscle is measured under the maximum expiration maneuver	Within 24 hours after the completion of surgery
Secondary	The incidence of postoperative pulmonary complication	The postoperative pulmonary complication is defined as when patient has developed one or more complications including pneumonia, atelectasis, pulmonary edema, pulmonary embolism, or respiratory failure	Through study completion, an average of 1 month
Secondary	The length of hospital stay	The length of hospital stay is counted by day	Through study completion, an average of 1 month
Secondary	The length of ICU stay	The length of ICU stay is counted by day	Through study completion, an average of 1 month
Secondary	Duration of mechanical ventilation	The duration of mechanical ventilation is counted by hours	Through study completion, an average of 1 month
Secondary	Hospital mortality	The hospital mortality is recorded at the time of discharge	Through study completion, an average of 1 month