NCT03291119

Brief Summary

CVJ anomalies affecting skeleton might lead to the pressure on the neuraxis, and disturbance of the cerebrospinal fluid circulation and blood supply. The patients undergoing surgeries on CVJ might develop airway complications in immediate postoperative period warranting urgent reintubation or emergency tracheostomy. Reintubation is usually difficult in immediate postoperative period due the fixation of cervical spine and gross upper airway oedema due to prolonged surgery in prone position. This will be the first prospective observational study to find out the risk factors related to patient, anaesthesia, radiological findings and surgical procedure to predict extubation failure in patients undergoing CVJ surgeries.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

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

First Submitted

Initial submission to the registry

March 6, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

March 6, 2017

Last Update Submit

September 19, 2017

Conditions

Cervical Lesion

Keywords

Cervico-medullary, Extubation Failure, Risk Predictors

Outcome Measures

Primary Outcomes (1)

  • Extubation failure will be evaluated in patients undergoing surgeries for CVJ surgery.

    Extubation failure is defined as failure to extubate or reintubation with in 24 Hrs postoperatively.

    1 year

Secondary Outcomes (1)

  • The association of various predictors with Outcome will be determined

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with CVJ Anomalies posted for surgery

Lists of Inclusion Criterion 1.Patients with CVJ Anomalies posted for surgery Lists of Exclusion Criterion: 1. Patients requiring preoperative intubation and ventilator support 2. Patients with Severe cardiac and pulmonary disease, Morbid obesity, Obstructive sleep apnoea, Clinically significant scoliosis, Severe neurological disability

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Officials

  • Kiran Jangra, DM

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiran Jangra, DM

CONTACT

0091-9914844330drkiransharma0117@gmail.com

Hemant Bhagat, DM

CONTACT

0091-7087009529hembhagat@rediffmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 6, 2017

First Posted

September 25, 2017

Study Start

October 31, 2017

Primary Completion

October 31, 2019

Study Completion

December 31, 2019

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share