A study to compare and assess a new technique to remove foreign material in respiratory tract in children through bronchoscopy

Not Applicable

Not yet recruiting

• Conditions: Exposure to other specified factors,

• Registration Number: CTRI/2019/03/018061
• Lead Sponsor: Richa Rai

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-04
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.ASA grade I to II 2.Recent H/O of tracheobronchial foreign body aspiration 3.Parents giving consent for participation in the study.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare the effect on intra-procedure and post-procedure hemodynamics	Heart rate,Non-invasive blood pressure and saturation will be recorded continuously every 3 minutes throughout the procedure and till return of consciousness.
(Heart Rate, Non-Invasive Blood Pressure) and oxygen saturation.	Heart rate,Non-invasive blood pressure and saturation will be recorded continuously every 3 minutes throughout the procedure and till return of consciousness.
2.Total dose of propofol used during procedure in both the groups.	Heart rate,Non-invasive blood pressure and saturation will be recorded continuously every 3 minutes throughout the procedure and till return of consciousness.
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sir Sunderlal Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Sir Sunderlal Hospital

🇮🇳Varanasi, UTTAR PRADESH, India

Richa Rai

Principal investigator

9452516982

richasgpgi@gmail.com