Diaphragm IssuesNCT05951114
Post-neurosurgical Respiratory Muscle Dysfunction
An observational study of Diaphragm Issues and Neurosurgery, run by Beijing Sanbo Brain Hospital at 1 site in China.
Trial summary
Respiratory muscle dysfunction may contribute to the development of postoperative pulmonary complications. However, it prevalence in patients receiving neurosurgery is largely unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Issues, Neurosurgery, Pulmonary Complication
- What is being tested?
- Maximum inspiratory/Expiratory manoeuvre for patients can follow the order
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients receiving elective surgery
Who may be able to join
- Informed consent
- First elective operation during hospitalization
- ASA<3
Who cannot join
- 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
Show all 9Show fewer
- BMI≥35kg/m2
- Pregnant women
- Skin lesions detected by ultrasound
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, 100090
Zhonghua Shi, PhD, 010-62856764
About this study
Official title: 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.
Read the 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.
- Conditions
- Diaphragm Issues, Neurosurgery, Pulmonary Complication
- Being tested
- Maximum inspiratory/Expiratory manoeuvre for patients can follow the order
- Keywords
- Neurosurgery, Respiratory muscle dysfunction, Diaphragm, Expiratory muscle, Post operative pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximum inspiratory/Expiratory manoeuvre for patients can follow the orderDiagnostic test
Also called End-expiratory occlusion in patients with endotracheal tube in situ
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with diaphragm weakness | Diaphragm weakness will be defined as thickening fraction <=20 % at the time of extubation Receives: 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 Receives: Diagnostic Test: Maximum inspiratory/Expiratory manoeuvre for patients can follow the order |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diaphragm dysfunction after neurosurgery
The diaphragm dysfunction is defined as the thickening fraction < 20% under the maximum inspiration
Measured: Within 24 hours after the completion of surgery
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 month
The length of hospital stay
The length of hospital stay is counted by day
Measured: Through study completion, an average of 1 month
The length of ICU stay
The length of ICU stay is counted by day
Measured: Through study completion, an average of 1 month
Duration of mechanical ventilation
The duration of mechanical ventilation is counted by hours
Measured: Through study completion, an average of 1 month
Hospital mortality
The hospital mortality is recorded at the time of discharge
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jul 2023
- Primary completion20 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diaphragm IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhonghua Shi, MD, PhD, Beijing Sanbo Brain Hospital
- Investigators
- Zhonghua Shi, PhD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951114
- Sponsor's protocol ID
- HP2023-28-508001
- Status last verified
- Apr 2024
- First submitted
- 8 Jun 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33711154Shi 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.
PubMed 31236639Tuinman 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.
PubMed 31938825
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Post-operative Respiratory Muscle Dysfunction in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT05951114
- Acronym / sponsor ID
- HP2023-28-508001
- Conditions
- Diaphragm Issues, Neurosurgery, Pulmonary Complication
- Keywords
- Neurosurgery, Respiratory muscle dysfunction, Diaphragm, Expiratory muscle, Post operative pulmonary complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diaphragm weakness | – | Diagnostic Test: Maximum inspiratory/Expiratory manoeuvre for patients can follow the orderDiaphragm weakness will be defined as thickening fraction <=20 % at the time of extubation |
| Patients without diaphragm weakness | – | Diagnostic Test: Maximum inspiratory/Expiratory manoeuvre for patients can follow the orderDiaphragm thickening fraction >20 % at the time of extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving elective surgery
Key inclusion criteria (3 listed)
- Informed consent
- First elective operation during hospitalization
- ASA<3
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximum inspiratory/Expiratory manoeuvre for patients can follow the orderAlso: End-expiratory occlusion in patients with endotracheal tube in situBedside 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 | Diagnostic test | Patients with diaphragm weakness, Patients without diaphragm weakness |
Primary outcome
Incidence of diaphragm dysfunction after neurosurgery
Time frame: Within 24 hours after the completion of surgery
The diaphragm dysfunction is defined as the thickening fraction < 20% under the maximum inspiration
9 secondary outcomes
The correlation between the level of NSE and the diaphragm function
Time frame: Within 24 hours after the completion of surgery
The correlation between the level of inflammation maker ILs and the diaphragm function
Time frame: Within 24 hours after the completion of surgery
The correlation between the level of inflammation maker TNF-alpha and the diaphragm function
Time frame: Within 24 hours after the completion of surgery
The thickening fraction of expiratory muscles after surgery
Time frame: Within 24 hours after the completion of surgery
The incidence of postoperative pulmonary complication
Time frame: Through study completion, an average of 1 month
The length of hospital stay
Time frame: Through study completion, an average of 1 month
The length of ICU stay
Time frame: Through study completion, an average of 1 month
Duration of mechanical ventilation
Time frame: Through study completion, an average of 1 month
Hospital mortality
Time frame: Through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 33711154Shi 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.
- Background: PubMed 31236639Shi 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.
- Background: PubMed 31938825Tuinman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhonghua Shi, PhD principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Issues and Neurosurgery, run by Beijing Sanbo Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhonghua Shi, PhD (62856764 ext. 010, z.shi@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diaphragm dysfunction after neurosurgery (time frame: Within 24 hours after the completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05951114, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.