| CTRI Number |
CTRI/2019/03/018061 [Registered on: 13/03/2019] Trial Registered Prospectively |
| Last Modified On: |
12/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare and assess a new technique to remove foreign material in respiratory tract in children through bronchoscopy |
|
Scientific Title of Study
|
A Comparative Evaluation of a Novel Technique for Bronchoscopy Guided Tracheobronchial Foreign Body
Removal in Children-A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Rai |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical Sciences-Banaras Hindu University |
| Address |
Department of Anesthesiology,
Sir Sunderlal Hospital,
Institute of Medical Sciences-Banaras Hindu University(IMS-BHU),
Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452516982 |
| Fax |
|
| Email |
richasgpgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Richa Rai |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical Sciences-Banaras Hindu University |
| Address |
Department of Anesthesiology,
Sir Sunderlal Hospital,
Institute of Medical Sciences-Banaras Hindu University(IMS-BHU),
Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452516982 |
| Fax |
|
| Email |
richasgpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa Rai |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical Sciences-Banaras Hindu University |
| Address |
Department of Anesthesiology,
Sir Sundarlal Hospital,
Institute of Medical Sciences-Banaras Hindu University(IMS-BHU),
Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452516982 |
| Fax |
|
| Email |
richasgpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Richa Rai,
Department of Anesthesiology,
Sir Sunderlal Hospital,
Institute of Medical Sciences-Banaras Hindu University(IMS-BHU),
Varanasi,
Uttar Pradesh. |
|
|
Primary Sponsor
|
| Name |
Richa Rai |
| Address |
Department of Anesthesiology,
Sir Sunderlal Hospital,
Institute of Medical Sciences-Banaras Hindu University |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Richa Rai |
Sir Sunderlal Hospital |
Department of Pediatric Surgery,
Operating Room 1 and 2,
Institute of Medical Sciences-Banaras Hindu University(IMS-BHU).
Varanasi
UTTAR PRADESH |
9452516982
richasgpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X58||Exposure to other specified factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% normal saline for placebo purpose |
Nebulisation and transtracheal block will be done by 0.9% normal saline 10-15 min prior to bronchoscopy |
| Intervention |
2ml of 2% lignocaine(nebulization) and 1 ml of 2% plain lignocaine(transtracheal block) |
Nebulization will be done with 2ml of 2% xylocaine for 10-15 minutes prior to bronchoscopy. After that , transtracheal block will be done with 1 ml of 2% plain lignocaine 10 minutes prior to procedure. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I to II
2.Recent H/O of tracheobronchial foreign body aspiration
3.Parents giving consent for participation in the study |
|
| ExclusionCriteria |
| Details |
1.Bronchoscopy through tracheostomy
2.Anterior neck swelling
3.Known allergy to local anesthetics
4.Renal, hepatic, or cardiovascular dysfunction, neurological disorders
5.Mental retardation or delayed milestones
6.Suspected coagulopathy
7.Parents refusal to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the effect on intra-procedure and post-procedure hemodynamics
(Heart Rate, Non-Invasive Blood Pressure) and oxygen saturation.
2.Total dose of propofol used during procedure in both the groups.
3.Post-procedure recovery |
Heart rate,Non-invasive blood pressure and saturation will be recorded continuously every 3 minutes throughout the procedure and till return of consciousness. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for complications encountered in such procedures like airway intervention, bronchospasm, laryngospasm, vocal cord injury and laryngeal or subglottic odema in both groups. |
Complications noted from start of bronchoscopy till completion of procedure and return of consciousness every 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/04/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
30 patients will be randomly divided into 2 groups. Patients will be premedicated with 0.05 mg/kg and glycopyrrolate 10 mcg/kg.
Induction will be done in both groups with fentanyl 2 mcg/kg and propofol 1-2 mg/kg in titrated dose before the start of procedure.
Group A - Patients will be nebulized with 2ml of 2% lignocaine for 10-15 minutes in preoperative room before induction. After induction, transtracheal block will be done with 1 ml of 2% plain lignocaine 10 minutes prior to procedure.
Group B - Nebulisation and airway block will done with normal saline for blinding purpose.
Immediately followed by infusion of propofol @50-150 mcg/kg/min for maintenance anesthesia. We will use rescue propofol intermittently depending upon the patients’ requirements. Rigid bronchoscopy will be performed by pediatric surgeons in all cases . HR, SPO2 and NIBP will be recorded continuously every 3 minutes throughout the procedure and patient will be observed for any event of desaturation or other adverse effects. All patients will be maintained on the spontaneous ventilation. After completion of procedure and stopping anesthetics, we will note the time duration of return to full consciousness and baseline saturation with any eventful episodes. To monitor recovery of consciousness at the end of procedure , MOAA(Modified Observers Assessment of Alertness/Sedation) scale will be used .
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