Diaphragm Ultrasound to Predict Posteroperative Residual Blockade

March 24, 2020 updated by: Jie YI, Peking Union Medical College Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Department of Anesthesiology, Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within1 min before extubation
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.
within 1 min after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reintubation rate
Time Frame: within 24 hour
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
Posteroperative pulmonary complication
Time Frame: 1 month
incidence of airway obstruction, bronchospasm, pulmonary aspiration of gastric contents, apnea, unexpected ICU admissions, atelectasis and pneumonia
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

April 30, 2020

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • DiaphragmUltra

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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