NCT04321681

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

March 18, 2020

Last Update Submit

March 24, 2020

Conditions

UltrasonographyResidual Curarization

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • reintubation rate

    within 24 hour

  • Posteroperative pulmonary complication

    1 month

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy director of surgery department

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 25, 2020

Study Start

June 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

CN(1)