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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04321681
Other study ID # DiaphragmUltra
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date April 30, 2020

Study information

Verified date March 2020
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Enrollment criteria:

1. Patients who were scheduled for elective non-abdominal and non-thoracic surgery in Peking Union medical college hospital.

2. age of 19-65 years

3. American Society of Anesthesiologists Physical Status Classification(ASA) I or II.

4. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
China Department of Anesthesiology, Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. within1 min before extubation
Primary 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. within 1 min after extubation
Secondary 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. within 24 hour
Secondary Posteroperative pulmonary complication incidence of airway obstruction, bronchospasm, pulmonary aspiration of gastric contents, apnea, unexpected ICU admissions, atelectasis and pneumonia 1 month
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