Post-neurosurgical Respiratory Muscle Dysfunction

NCT ID: NCT05951114

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-03-01

Brief Summary

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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

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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.

Conditions

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Diaphragm Issues Neurosurgery Pulmonary Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with diaphragm weakness

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

Maximum inspiratory/Expiratory manoeuvre for patients can follow the order

Intervention Type 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

Patients without diaphragm weakness

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

Maximum inspiratory/Expiratory manoeuvre for patients can follow the order

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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End-expiratory occlusion in patients with endotracheal tube in situ

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Sanbo Brain Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhonghua Shi, MD, PhD

Deputy president of the department ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhonghua Shi, PhD

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Locations

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Beijing Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhonghua Shi, PhD

Role: CONTACT

62856764 ext. 010

Facility Contacts

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Zhonghua Shi, PhD

Role: primary

010-62856764

References

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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.

Reference Type BACKGROUND
PMID: 33711154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31236639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31938825 (View on PubMed)

Other Identifiers

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HP2023-28-508001

Identifier Type: -

Identifier Source: org_study_id

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