Post-neurosurgical Respiratory Muscle Dysfunction

NCT05951114 | Recruiting

• 1 other identifier: HP2023-28-508001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragm Issues; Neurosurgery; Pulmonary Complication

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The correlation between the level of NSE and the diaphragm function

  Within 24 hours after the completion of surgery

• The correlation between the level of inflammation maker ILs and the diaphragm function

  Within 24 hours after the completion of surgery

• The correlation between the level of inflammation maker TNF-alpha 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 incidence of postoperative pulmonary complication

  Through study completion, an average of 1 month

Study Arms (2)

Patients with diaphragm weakness

Diaphragm weakness will be defined as thickening fraction \<=20 % at the time of extubation

Diagnostic Test: Maximum inspiratory/Expiratory manoeuvre for patients can follow the order

Patients without diaphragm weakness

Diaphragm thickening fraction \>20 % at the time of extubation

Diagnostic Test: Maximum inspiratory/Expiratory manoeuvre for patients can follow the order

Interventions

Maximum inspiratory/Expiratory manoeuvre for patients can follow the order DIAGNOSTIC_TEST

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

Also known as: End-expiratory occlusion in patients with endotracheal tube in situ

Patients with diaphragm weakness; Patients without diaphragm weakness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients receiving elective surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (1)

Beijing Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing Municipality, 100090, China

RECRUITING

Related 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.

  PMID: 33711154 BACKGROUND

• 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.

  PMID: 31236639 BACKGROUND

• 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.

  PMID: 31938825 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample will be collected based on clinical routine, and IL-6, IL-10, TNFα, NSE

Study Officials

• Zhonghua Shi, PhD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhonghua Shi, PhD

CONTACT

62856764; z.shi@mail.ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy president of the department ICU

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 18, 2023
• Study Start: July 1, 2023
• Primary Completion: September 20, 2024
• Study Completion: March 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)