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CTRI Number  CTRI/2020/09/027649 [Registered on: 08/09/2020] Trial Registered Prospectively
Last Modified On: 15/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Transcutaneous CO2 monitoring in Paediatric Endoscopy  
Scientific Title of Study   Transcutaneous CO2 monitoring in Paediatric Endoscopic procedures as an early marker for alveolar hypoventilation. A prospective 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  Badal Parikh 
Designation  Assoc Prof  
Affiliation  Army Hospital (R and R) 
Address  Dept of Anaesthesia Army Hospital (R and R) Delhi Cantt

South West
DELHI
110010
India 
Phone    
Fax    
Email  drbadalparikh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Badal Parikh 
Designation  Assoc Prof  
Affiliation  Army Hospital (R and R) 
Address  Dept of Anaesthesia Army Hospital (R and R) Delhi Cantt

South West
DELHI
110010
India 
Phone    
Fax    
Email  drbadalparikh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Badal Parikh 
Designation  Assoc Prof  
Affiliation  Army Hospital (R and R) 
Address  Dept of Anaesthesia Army Hospital (R and R) Delhi Cantt

South West
DELHI
110010
India 
Phone    
Fax    
Email  drbadalparikh@gmail.com  
 
Source of Monetary or Material Support  
Dept Of Anesthesia Army Hospital (Research and Referral) Delhi Cantt 110010 
 
Primary Sponsor  
Name  Badal Parikh 
Address  Dept Of Anesthesia Army Hospital (Research and Referral) Delhi Cantt 110010 
Type of Sponsor  Other [Self] 
 
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 
Dr Badal Parikh  Gastroenterology Suite   Dept of Anaesthesia Army Hospital ( R and R)
South West
DELHI 
7073088722

drbadalparikh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Army Hospital (R&R)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists Class I or II
Scheduled for endoscopic procedures  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective is to determine whether Transcutaneous CO2 monitoring
in paediatric patients undergoing endoscopic procedures predicts severe hypoventilation
 
Transcutaneous monitoring will be initiated 5 minutes before administration of sedative agents and continue until at least 10 minutes after final withdrawal of the endoscope 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective is to assess the accuracy of Transcutaneous CO2 with PaCO2 in paediatric patients  Transcutaneous monitoring will be initiated 5 minutes before administration of sedative agents and continue until at least 10 minutes after final withdrawal of the endoscope 
 
Target Sample Size   Total Sample Size="152"
Sample Size from India="152" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2020 
Date of Study Completion (India) 31/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Endoscopic procedures are increasingly becoming standard of care in a number of diseases in paediatric patients. With escalating complexity of Gastro-endoscopic proce- dures in background of paediatric age gp, disease profile and vulnerable location, ad- ministering sedation/ anaesthesia has become more challenging than ever. Drug in- duced respiratory compromise is a major cause of sedation-associated morbidity in these patient subset, therefore monitoring and vigilance for early signs of systemic com- promise and alveolar hypoventilation is essential. Pulse-oximetry (SpO2) has been established as standard practice to detect hypoxemia as clinical observation alone was insufficient. However, oxygen saturation measured with SpO2 provides only a sur- rogate measure of arterial oxygen saturation (SaO2) and does not completely reflect ventilation. Moreover O2 supplementation during the procedure masks alveolar hy- poventilation by increasing FiO2 and maintaining SpO2. CO2 retention is a hallmark of alveolar hypoventilation and frequent in opioid and propofol based Total Intravenous Anaesthesia(TIVA) techniques. End-tidal carbon dioxide(EtCO2) monitoring has been validated and recommended by American Society of Anesthesiologists and American Society of Gastrointestinal Endoscopy (ASGE) in their guidelines for deep sedation However, during endoscopic procedures EtCO2 monitoring has often found to be difficult and unreliable. Transcutaneous carbon dioxide tension measurement (PtcCO2) combined with conventional monitoring has the potential to become the standard of care in paediatric endoscopic procedures. This Study aims to evaluate the accuracy of Transcutaneous carbon dioxide (PtcCO2) monitoring during paediatric endoscopic proce- dures in predicting hypoventilation over conventional clinical and monitoring techniques.

Methodology 

All paediatric patients between 2-8 years of age (American Society of Anaesthesiologists Class I or II) scheduled for endoscopic procedures will be enrolled for the study. All children will be premedicatied with iv midazolam 75mcg-100mcg/ kg 5-10 mins prior to procedure. Before each procedure the PtcCO2 electrode will be calibrated and baseline PtcCO2 and pulse oximetry (SpO2) will be determined. Physiologic and clinical monitoring will be initiated 5 minutes before administration of sedative agents and continue until at least 10 minutes after final withdrawal of the endoscope. TIVA will be given by an anesthesiologist experienced in handing paediatric patients using a combi- nation of fentanyl midazolam, propofol, and ketamine in a weight-adjusted dose titrating to effect. All patients will be kept spontaneously breathing. For each patient, PtcCO2 and vital parameters (ECG, HR, SPO2, Respiratory Rate, and Pulse Rate) will be recorded every 5 mins and the trend of the vital parameters were closely monitored. Simultane- ously ABG samples will be collected before, at 20 mins and after the procedure for PaCO2 measurements. A respiratory event will be defined as a combination of a 20% change (increase) in PtcCO2 or > 50 mm Hg and SpO2 < 90% for > 1 min. All patients will be on supplemental O2 @ 2L/min by nasal prongs

Sample Size Calculation : The incidence of severe hypoventilation in endoscopic and pediatric sedation is approx 30%.  To find a decrease in incidence to 10% with Î± er- ror of 0.05 and power of 80% a sample size of 152 was calculated.

Statistics : Distribution of the continuous data will be tested with the Komolgorov– Smirnov one-sample test. Continuous variables with a normal distribution will be ex- pressed as mean + standard deviation (SD). Dichotomous data will be expressed as numbers and percentages. Numerical data will be analysed using Student’s t-tests while Nominal variables will be assessed using either the x2 or the Fisher tests. P value <0.05 will be considered statistically significant.

(e) Scope of the project

Our centre provides anaesthesia services to paediatric endoscopic procedures. The challenge of providing anaesthesia in out of OR multifolds in paediatric cases owing to physiology in children which make them more prone for cardiorespiratory events. Presently the standard of care for monitoring in paediatric endoscopic procedures under sedation relies overly on pulse oximetrywhich underestimates hypoventilation. Transcutaneous CO2 tension closely correlates with the PaCO2 values, therefore can be considered an early marker of alveolar hypoventilation. So this study aspires to establish TCO2 as standard of care monitoring in paediatric endoscopic procedures.



 
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