Mechanical VentilationNCT07235956
The Ratio of Diaphragmatic Movement Between the Midaxillary Line and the Midclavicular Line Predicts the Success Rate of Weaning From Mechanical Ventilation
An observational study of Mechanical Ventilation, run by Zheng Qingjiang.
Trial summary
This study will provide individualized objective indicators for patients undergoing invasive mechanical ventilation. It will set specific assessment parameters for weaning and extubation for different patients, increase the success rate of weaning, avoid the damage and medical risks of re-intubation, and shorten the… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning.
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is an observational cohort study. Patients who received invasive mechanical ventilation in the intensive care unit of our hospital from October 1, 2025 to December 31, 2026 were collected. The diaphragmatic excursion at the midclavicular line and the midaxillary line of each patient was measured using ultrasound, and the ratio of the diaphragmatic excursion at the two lines was calculated. The main content was to monitor the diaphragmatic excursion at the midclavicular line and the midaxillary line, and calculate the ratio; the monitoring time points were the first day, the third day, the seventh day (if applicable), the 14th day (if applicable), and before weaning and extubation, and at the same time, the patients' serum albumin, serum prealbumin, hemoglobin, oxygenation index, etc. were observed for treatment.
Who may be able to join
- Patients who were admitted to the ICU and had invasive mechanical ventilation for more than 72 hours.
Who cannot join
- Patients with irreversible multi-organ failure; Patients with advanced tumors
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Prediction of the Success Rate of Weaning From Invasive Mechanical Ventilation in Patients by the Ratio of Diaphragmatic Mobility Between the Mid-clavicular Line and the Mid-axillary Line
This study will provide individualized objective indicators for patients undergoing invasive mechanical ventilation. It will set specific assessment parameters for weaning and extubation for different patients, increase the success rate of weaning, avoid the damage and medical risks of re-intubation, and shorten the hospital stay. The main observation targets of this study are: whether weaning is successful; the secondary targets are: specific numerical values of diaphragmatic mobility along the midclavicular line and midaxillary line, oxygenation index, and whether re-intubation occurs within 48 hours. This study is an observational study. The expected study duration is 18 months, and there is no risk of study interruption.
Read the detailed description
Research Background: Invasive mechanical ventilation is a commonly used rescue measure for critically ill patients. After treatment and improvement, due to factors such as disease damage and the patient's physical condition, one-third of the patients will become dependent on ventilators, resulting in failed weaning. The diaphragm, as the most crucial respiratory muscle, undertakes 60-79% of the ventilation function. However, a combination of factors such as invasive mechanical ventilation, analgesic and sedative drugs, muscle relaxants, disease damage, delayed rehabilitation, and insufficient nutrient supply can lead to rapid diaphragm atrophy in patients. Therefore, an objective and accurate assessment of diaphragm function is crucial for predicting the wear-off success rate of patients with invasive mechanical ventilation. It is of great significance. At present, the research on diaphragmatic ultrasound mainly focuses on diaphragmatic mobility, diaphragmatic thickening rate, and peak diaphragmatic contraction. However, there are differences in the basal diaphragmatic thickness and mobility among each patient. Moreover, the physiological contraction amplitudes of the diaphragm are different, such as smaller ventral amplitude and larger dorsal amplitude. Our research measured the diaphragmatic mobility along the midaxillary line and the midclavicular line, and calculated the ratio of the two. Taking the successful weaning of patients as the main criterion, they were divided into the successful weaning group and the failed weaning group. The odds ratios of the two groups were compared for statistical analysis to determine whether there were statistical differences. The purpose was to provide individualized objective parameters for the weaning and extubation of patients with invasive mechanical ventilation.
Research Objective: This study aims to provide individualized objective indicators for patients on invasive mechanical ventilation, assess parameters for weaning and extubation for different patients, increase the success rate of weaning, avoid the injury and medical risks of re-intubation within 48 hours, and shorten the hospital stay. The primary observation objective of this study is whether weaning is successful or not. The secondary objectives are the specific values of diaphragmatic mobility at the midclavicular and midaxillary lines, oxygenation index, and whether re-intubation occurs within 48 hours. This study is an observational study, with an expected research period of 18 months, and there is no risk of study interruption.
This study is an observational cohort study. Patients who received invasive mechanical ventilation in the intensive care unit of our hospital from October 1, 2025 to December 31, 2026 were collected. The diaphragmatic excursion at the midclavicular line and the midaxillary line of each patient was measured using ultrasound, and the ratio of the diaphragmatic excursion of the two was calculated. The main content was to monitor the diaphragmatic excursion at the midclavicular line and the midaxillary line, and calculate the ratio; the monitoring time points were the first day, the third day, the seventh day (if applicable), the 14th day (if applicable), and before weaning and extubation, while observing the patients' serum albumin, serum prealbumin, hemoglobin, oxygenation index, etc. for treatment. The research content only focuses on human samples and medical treatment data, not on research interventions on the human body.
Research Design: This study is a retrospective observational case-control study. Based on: By reviewing previous literature and using the formula for calculating sample size in medicine: n = Z² × σ²/d² (where, Z is the confidence interval, n is the sample size, d is the sampling error range, σ is the standard deviation, typically taken as 0.5), the sample size was calculated to be 120 cases. According to whether the weaning was successful or not, the cases were divided into the successful group and the failed group; the parameters such as the ratio of diaphragm movement, PA, aPA, oxygenation index at the above time points were collected between the two groups for statistical analysis; the data were analyzed using SPSS 25.0 version (IBM Company, Armonk, New York, USA). The Shapiro-Wilk test was used to evaluate the normality of continuous variables. Variables with normal distribution were presented in the form of mean ± standard deviation and compared using the Student t-test. Variables with non-normal distribution were presented in the form of median (interquartile range) and compared using the Mann-Whitney U test. Categorical variables were presented in the form of frequency (percentage) and compared using the chi-square test or Fisher's exact test. In pairwise comparisons of ultrasound parameters at different time points within each group, repeated measures analysis of variance with Bonferroni correction was used. The receiver operating characteristic (ROC) curve was constructed to evaluate the predictive value of ultrasound parameters for 28-day mortality. The area under the curve (AUC) was calculated, and the optimal cut-off value was determined using the Youden index. A bilateral p-value < 0.05 is considered statistically significant. To address potential confounding factors, a multivariate logistic regression analysis was conducted, and age and the Acute Physiology and Chronic Health Evaluation II score (APACHE II) were adjusted simultaneously.
- Conditions
- Mechanical Ventilation
- Being tested
- Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning.
- Keywords
- Diaphragmatic mobility, Invasive mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning.Diagnostic test
Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning.
| Study group | Role | What they receive |
|---|---|---|
| Group with successful extubation of invasive mechanical ventilation | Not described Receives: Diagnostic Test: Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of weaning from invasive mechanical ventilation
Measured: From enrollment to the outcome of extubation with invasive mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zheng Qingjiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Qingjiang, Zhangzhou Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235956
- Sponsor's protocol ID
- 2025LWB429
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have signed a personal informed consent form with the patient, and the patient's private information is protected from disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Prediction of the Success Rate of Weaning From Invasive Mechanical Ventilation in Patients by the Ratio of Diaphragmatic Mobility Between the Mid-clavicular Line and the Mid-axillary Line
- ClinicalTrials.gov ID
- NCT07235956
- Acronym / sponsor ID
- 2025LWB429
- Conditions
- Mechanical Ventilation
- Keywords
- Diaphragmatic mobility, Invasive mechanical ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zheng QingjiangUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
This study will provide individualized objective indicators for patients undergoing invasive mechanical ventilation. It will set specific assessment parameters for weaning and extubation for different patients, increase the success rate of weaning, avoid the damage and medical risks of re-intubation, and shorten the hospital stay. The main observation targets of this study are: whether weaning is successful; the secondary targets are: specific numerical values of diaphragmatic mobility along the midclavicular line and midaxillary line, oxygenation index, and whether re-intubation occurs within 48 hours. This study is an observational study. The expected study duration is 18 months, and there is no risk of study interruption.
Detailed description
Research Background: Invasive mechanical ventilation is a commonly used rescue measure for critically ill patients. After treatment and improvement, due to factors such as disease damage and the patient's physical condition, one-third of the patients will become dependent on ventilators, resulting in failed weaning. The diaphragm, as the most crucial respiratory muscle, undertakes 60-79% of the ventilation function. However, a combination of factors such as invasive mechanical ventilation, analgesic and sedative drugs, muscle relaxants, disease damage, delayed rehabilitation, and insufficient nutrient supply can lead to rapid diaphragm atrophy in patients. Therefore, an objective and accurate assessment of diaphragm function is crucial for predicting the wear-off success rate of patients with invasive mechanical ventilation. It is of great significance. At present, the research on diaphragmatic ultrasound mainly focuses on diaphragmatic mobility, diaphragmatic thickening rate, and peak diaphragmatic contraction. However, there are differences in the basal diaphragmatic thickness and mobility among each patient. Moreover, the physiological contraction amplitudes of the diaphragm are different, such as smaller ventral amplitude and larger dorsal amplitude. Our research measured the diaphragmatic mobility along the midaxillary line and the midclavicular line, and calculated the ratio of the two. Taking the successful weaning of patients as the main criterion, they were divided into the successful weaning group and the failed weaning group. The odds ratios of the two groups were compared for statistical analysis to determine whether there were statistical differences. The purpose was to provide individualized objective parameters for the weaning and extubation of patients with invasive mechanical ventilation.
Research Objective: This study aims to provide individualized objective indicators for patients on invasive mechanical ventilation, assess parameters for weaning and extubation for different patients, increase the success rate of weaning, avoid the injury and medical risks of re-intubation within 48 hours, and shorten the hospital stay. The primary observation objective of this study is whether weaning is successful or not. The secondary objectives are the specific values of diaphragmatic mobility at the midclavicular and midaxillary lines, oxygenation index, and whether re-intubation occurs within 48 hours. This study is an observational study, with an expected research period of 18 months, and there is no risk of study interruption.
This study is an observational cohort study. Patients who received invasive mechanical ventilation in the intensive care unit of our hospital from October 1, 2025 to December 31, 2026 were collected. The diaphragmatic excursion at the midclavicular line and the midaxillary line of each patient was measured using ultrasound, and the ratio of the diaphragmatic excursion of the two was calculated. The main content was to monitor the diaphragmatic excursion at the midclavicular line and the midaxillary line, and calculate the ratio; the monitoring time points were the first day, the third day, the seventh day (if applicable), the 14th day (if applicable), and before weaning and extubation, while observing the patients' serum albumin, serum prealbumin, hemoglobin, oxygenation index, etc. for treatment. The research content only focuses on human samples and medical treatment data, not on research interventions on the human body.
Research Design: This study is a retrospective observational case-control study. Based on: By reviewing previous literature and using the formula for calculating sample size in medicine: n = Z² × σ²/d² (where, Z is the confidence interval, n is the sample size, d is the sampling error range, σ is the standard deviation, typically taken as 0.5), the sample size was calculated to be 120 cases. According to whether the weaning was successful or not, the cases were divided into the successful group and the failed group; the parameters such as the ratio of diaphragm movement, PA, aPA, oxygenation index at the above time points were collected between the two groups for statistical analysis; the data were analyzed using SPSS 25.0 version (IBM Company, Armonk, New York, USA). The Shapiro-Wilk test was used to evaluate the normality of continuous variables. Variables with normal distribution were presented in the form of mean ± standard deviation and compared using the Student t-test. Variables with non-normal distribution were presented in the form of median (interquartile range) and compared using the Mann-Whitney U test. Categorical variables were presented in the form of frequency (percentage) and compared using the chi-square test or Fisher's exact test. In pairwise comparisons of ultrasound parameters at different time points within each group, repeated measures analysis of variance with Bonferroni correction was used. The receiver operating characteristic (ROC) curve was constructed to evaluate the predictive value of ultrasound parameters for 28-day mortality. The area under the curve (AUC) was calculated, and the optimal cut-off value was determined using the Youden index. A bilateral p-value < 0.05 is considered statistically significant. To address potential confounding factors, a multivariate logistic regression analysis was conducted, and age and the Acute Physiology and Chronic Health Evaluation II score (APACHE II) were adjusted simultaneously.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group with successful extubation of invasive mechanical ventilation | – | Diagnostic Test: Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is an observational cohort study. Patients who received invasive mechanical ventilation in the intensive care unit of our hospital from October 1, 2025 to December 31, 2026 were collected. The diaphragmatic excursion at the midclavicular line and the midaxillary line of each patient was measured using ultrasound, and the ratio of the diaphragmatic excursion at the two lines was calculated. The main content was to monitor the diaphragmatic excursion at the midclavicular line and the midaxillary line, and calculate the ratio; the monitoring time points were the first day, the third day, the seventh day (if applicable), the 14th day (if applicable), and before weaning and extubation, and at the same time, the patients' serum albumin, serum prealbumin, hemoglobin, oxygenation index, etc. were observed for treatment.
Key inclusion criteria (1 listed)
- Patients who were admitted to the ICU and had invasive mechanical ventilation for more than 72 hours.
Key exclusion criteria (1 listed)
- Patients with irreversible multi-organ failure; Patients with advanced tumors
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 |
|---|---|---|
| Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning.Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning. | Diagnostic test | Group with successful extubation of invasive mechanical ventilation |
Primary outcome
The success rate of weaning from invasive mechanical ventilation
Time frame: From enrollment to the outcome of extubation with invasive mechanical ventilation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No. We have signed a personal informed consent form with the patient, and the patient's private information is protected from disclosure.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by Zheng Qingjiang.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingjiang Zheng, Master of Clinical Medicine (8613799824987, qingjiang233@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of weaning from invasive mechanical ventilation (time frame: From enrollment to the outcome of extubation with invasive mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025.