UltrasonographyNCT04321681
Diaphragm Ultrasound to Predict Posteroperative Residual Blockade
An observational study of Ultrasonography and Residual Curarization, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a prospective observational research approved by the Ethics Committee of the Peking Union medical college Hospital. Patients scheduled for elective non-abdominal and non-thoracic surgery among age of 19-65 years and American Society of Anesthesiologists Physical Status Classification(ASA) I or II were… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Residual Curarization
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 30 Apr 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for elective non-abdominal and non-thoracic surgery in Peking Union medical college hospital. All were among age of 19-65 years and American Society of Anesthesiologists Physical Status Classification(ASA) I or II.
Enrollment criteria：
- Patients who were scheduled for elective non-abdominal and non-thoracic surgery in Peking Union medical college hospital.
- age of 19-65 years
- American Society of Anesthesiologists Physical Status Classification(ASA) I or II.
- Agree to informed consent
Exclusion criteria ： Patients with neuromuscular diseases, diaphragmatic palsy, thoracic malformation, hand disabilities, chronic obstructive pulmonary disease, severe liver or kidney diseases, electrolyte or acid-base disorders, morbid obesity (body mass index ≥30 kg/m2), pregnancy, allergy to drugs used in the study, use of medication interfering neuromuscular transmission within 72hours and patients with predicted difficulty in maintenance of airway were excluded from this study. Written informed consent will be obtained before preoperative evaluation by an anesthesiologist.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yuguang Huang, MD, +86 10 69152020, garybeijing@163.com
Jie Yi, MD, easyue@163.com
About this study
This study is a prospective observational research approved by the Ethics Committee of the Peking Union medical college Hospital. Patients scheduled for elective non-abdominal and non-thoracic surgery among age of 19-65 years and American Society of Anesthesiologists Physical Status Classification(ASA) I or II were inrolled. Diaphragm ultrasonogram was measured pre and post operation. Diaphragm excursion and diaphragm thickening fraction during quiet breathing as well as deep breathing were assessed. Neuromuscular monitor was performed during operation, after proper calibration.
- Conditions
- Ultrasonography, Residual Curarization
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
TOFr at extubation
Neuromuscular function was monitored thoughout operation based neuromuscular monitoring guideline by an independent investigator. TOF ratio before extubation was recorded. The scale of TOFr range from 0 to 1. TOFr<0.9 indicate existance of residual neuromuscular blockade.
Measured: within1 min before extubation
Diaphragm ultrasound parameter
Diaphragm excursion and thickening fraction was measured through ultrasonography within 2 min after extubation. Correlation between TOFr ratio and diaphragm parameters was explored.
Measured: within 1 min after extubation
Secondary outcomes (2)
reintubation rate
If patients cannot breath by themselves after extubation, They need to be reintubated and mechanical ventilation need to be use to sustain their breathing.
Measured: within 24 hour
Posteroperative pulmonary complication
incidence of airway obstruction, bronchospasm, pulmonary aspiration of gastric contents, apnea, unexpected ICU admissions, atelectasis and pneumonia
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Jun 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie YI, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321681
- Sponsor's protocol ID
- DiaphragmUltra
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Ultrasound to Predict Posteroperative Residual Blockade
- ClinicalTrials.gov ID
- NCT04321681
- Acronym / sponsor ID
- DiaphragmUltra
- Conditions
- Ultrasonography, Residual Curarization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 25 Mar 2020 (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 is a prospective observational research approved by the Ethics Committee of the Peking Union medical college Hospital. Patients scheduled for elective non-abdominal and non-thoracic surgery among age of 19-65 years and American Society of Anesthesiologists Physical Status Classification(ASA) I or II were inrolled. Diaphragm ultrasonogram was measured pre and post operation. Diaphragm excursion and diaphragm thickening fraction during quiet breathing as well as deep breathing were assessed. Neuromuscular monitor was performed during operation, after proper calibration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective non-abdominal and non-thoracic surgery in Peking Union medical college hospital. All were among age of 19-65 years and American Society of Anesthesiologists Physical Status Classification(ASA) I or II.
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
TOFr at extubation
Time frame: within1 min before extubation
Neuromuscular function was monitored thoughout operation based neuromuscular monitoring guideline by an independent investigator. TOF ratio before extubation was recorded. The scale of TOFr range from 0 to 1. TOFr<0.9 indicate existance of residual neuromuscular blockade.
Diaphragm ultrasound parameter
Time frame: within 1 min after extubation
Diaphragm excursion and thickening fraction was measured through ultrasonography within 2 min after extubation. Correlation between TOFr ratio and diaphragm parameters was explored.
2 secondary outcomes
reintubation rate
Time frame: within 24 hour
Posteroperative pulmonary complication
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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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.
Department of Anesthesiology, Peking Union Medical College Hospital
Beijing, China
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 Ultrasonography and Residual Curarization, run by Peking Union Medical College 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?
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 25 Mar 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TOFr at extubation (time frame: within1 min before extubation). The study lists 2 primary outcomes in all. 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 25 Mar 2020.