Diaphragm Ultrasound to Predict Posteroperative Residual Blockade

Ultrasonography Clinical Trial

Official title:

Diaphragm Ultrasound to Predict Posteroperative Residual Blockade

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04321681
• Other study ID #: DiaphragmUltra
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Residual Curarization
• Ultrasonography

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