Post-neurosurgical Respiratory Muscle Dysfunction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Complication; Neurosurgery; Diaphragm Issues
• Intervention / Treatment: Diagnostic test: Maximum inspiratory/Expiratory manoeuvre for patients can follow the order

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Zhonghua Shi, PhD; Phone Number: 010 62856764; Email: z.shi@mail.ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100090
      • Recruiting
      • Beijing Sanbo Brain Hospital, Capital Medical University
      • Contact: Zhonghua Shi, PhD; Phone Number: 010-62856764

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients receiving elective surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Other Names: End-expiratory occlusion in patients with endotracheal tube in situ
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; 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; Other Names: End-expiratory occlusion in patients with endotracheal tube in situ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
The length of hospital stay	The length of hospital stay is counted by day	Through study completion, an average of 1 month
The length of ICU stay	The length of ICU stay is counted by day	Through study completion, an average of 1 month
Duration of mechanical ventilation	The duration of mechanical ventilation is counted by hours	Through study completion, an average of 1 month
Hospital mortality	The hospital mortality is recorded at the time of discharge	Through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Beijing Sanbo Brain Hospital
• Investigators: Principal Investigator: Zhonghua Shi, PhD, Capital Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diaphragm; Neurosurgery; Respiratory muscle dysfunction; Expiratory muscle; Post operative pulmonary complications
• Other Study ID Numbers: HP2023-28-508001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No