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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T175||Foreign body in bronchus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
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
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.


 
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