Neurosurgery Clinical Trial
Official title:
The Development of Post-operative Respiratory Muscle Dysfunction in Neurosurgical Patients
NCT number | NCT05951114 |
Other study ID # | HP2023-28-508001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | July 1, 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Sanbo Brain Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Sanbo Brain Hospital |
China,
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
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 |
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