| CTRI Number |
CTRI/2021/01/030266 [Registered on: 05/01/2021] Trial Registered Prospectively |
| Last Modified On: |
01/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Identification of complications occurring during and after removal of foreign body from the respiratory tract in children under general anaesthesia. |
|
Scientific Title of Study
|
Perioperative complications in children undergoing airway foreign body removal by rigid bronchoscopy under general anaesthesia – an observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Govindaraj M |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh - 160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
8220082549 |
| Fax |
|
| Email |
govindm25195@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sandhya Yaddanapudi |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh - 160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
9872005576 |
| Fax |
|
| Email |
sandhya.yaddanapudi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sandhya Yaddanapudi |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh - 160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
9872005576 |
| Fax |
|
| Email |
sandhya.yaddanapudi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education And Research |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education And Research |
| Address |
Post Graduate Institute of Medical Education and Research,
Sector 12, Chandigarh - 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Govindaraj M |
Post Graduate Institute of Medical Education and Research |
Advanced Pediatric Centre Operation Theatre, Level 6, Sector 12, Chandigarh - 160012 Chandigarh CHANDIGARH |
8220082549
govindm25195@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T175||Foreign body in bronchus, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Children less than 13 years of age undergoing rigid bronchoscopy foreign body removal |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
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Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of various perioperative complications in children undergoing airway foreign body removal by rigid bronchoscopy under general anaesthesia. |
Intraoperative and Postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the risk factors for the development of perioperative complications in children undergoing foreign body removal by rigid bronchoscopy under general anesthesia |
Intraoperative and postoperative periods |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Foreign Body (FB) aspiration refers to the accidental entry of foreign body into the airway either through mouth or nose. It can occur at any age but is mostly seen in children less than 3 years of age. This occurs because young children tend to explore objects orally, along with their inability to chew the food adequately due to incomplete dentition, and due to incoordinated swallowing-breathing at this age. The clinical features following FB aspiration depend on many factors including nature of the FB – whether organic or inorganic, size of the FB, and the duration of aspiration. The diagnosis of airway FB depends largely on history, clinical findings, and radiological imaging. Bronchoscopic removal of FB is recommended once the diagnosis is established. Both rigid and flexible fiberoptic bronchoscopes can be used for FB removal. Rigid bronchoscopes are preferred over flexible bronchoscopes because they provide a wide channel for insertion of instruments for the removal of FB. The rigid bronchoscopes also allow ventilation during the procedure through the side port. Rigid bronchoscopy is performed under general anaesthesia. A deep plane of anaesthesia is required for the procedure. Even though bronchoscopy is safer now than it was earlier, it is associated with several complications, the reasons being the presence of airway and pulmonary pathology due to the FB, sharing of the airway by the surgeons and the anaesthetists, periods of apnoea during the procedure, among others. Minor complications include trauma to the teeth, oropharynx, or vocal cords, desaturation, hypotension, hypertension, bradycardia, tachycardia, need for postoperative oxygen supplementation, transient coughing/stridor/dyspnea after the procedure. Major complications include laryngeal edema, laryngospasm, bronchospasm, cardiac arrhythmias, pneumothorax, subcutaneous emphysema, tracheal perforation, need for postoperative mechanical ventilation or unplanned ICU admission, cardiorespiratory arrest and death. The incidence of these adverse events is dependent on several patient, procedure and anaesthesia related factors. A few studies have evaluated the risk factors which are associated with these complications. However, most studies are retrospective in nature. There are very few Indian studies which have studied the risk factors associated with complications during bronchoscopy. The aim of the present study is to determine the incidence of various perioperative complications in children undergoing airway foreign body removal by rigid bronchoscopy under general anaesthesia. We also propose to determine the risk factors for the development of perioperative complications. |