Clinical trial NCT05951114: Post-neurosurgical Respiratory Muscle Dysfunction
Official title: The Development of Post-operative Respiratory Muscle Dysfunction in Neurosurgical Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diaphragm Issues
Neurosurgery
Pulmonary Complication
Keywords: Neurosurgery
Respiratory muscle dysfunction
Diaphragm
Expiratory muscle
Post operative pulmonary complications
Lead sponsor: Beijing Sanbo Brain Hospital
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients receiving elective surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of diaphragm dysfunction after neurosurgery
timeFrame: Within 24 hours after the completion of surgery
Secondary outcomes:
measure: The correlation between the level of NSE and the diaphragm function
timeFrame: Within 24 hours after the completion of surgery
measure: The correlation between the level of inflammation maker ILs and the diaphragm function
timeFrame: Within 24 hours after the completion of surgery
measure: The correlation between the level of inflammation maker TNF-alpha and the diaphragm function
timeFrame: Within 24 hours after the completion of surgery
measure: The thickening fraction of expiratory muscles after surgery
timeFrame: Within 24 hours after the completion of surgery
measure: The incidence of postoperative pulmonary complication
timeFrame: Through study completion, an average of 1 month
measure: The length of hospital stay
timeFrame: Through study completion, an average of 1 month
measure: The length of ICU stay
timeFrame: Through study completion, an average of 1 month
measure: Duration of mechanical ventilation
timeFrame: Through study completion, an average of 1 month
measure: Hospital mortality
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Sanbo Brain Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Zhonghua Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.