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CTRI Number  CTRI/2018/02/011697 [Registered on: 05/02/2018] Trial Registered Retrospectively
Last Modified On: 01/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A prospective study to compare effects of laparoscopic surgery on haemodynamic and respiratory parameters using two different techniques of airway management in children  
Scientific Title of Study   A prospective study to compare the effects of pneumoperitoneum on haemodynamic and respiratory parameters using proseal lma and endotracheal intubation in children undergoing videoendoscopic surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amit Wankhede 
Designation  Senior Resident 
Affiliation  Government Medical College Nagpur 
Address  Nagpur
Anesthesia Department Government Medical College Hanuman Nagar Nagpur
Nagpur
MAHARASHTRA
440027
India 
Phone  9582414799  
Fax    
Email  amit22gmcnagpur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  G Usha 
Designation  Consultant and professor 
Affiliation  Vardhaman Mahavir Medical College and Safderjung Hospital 
Address  New Delhi
Anesthesia Department VMMC and SJH Ansari Nagar West New Delhi
New Delhi
DELHI
110070
India 
Phone  8447795934  
Fax    
Email  doctorgusha@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Amit Wankhede 
Designation  Senior Resident 
Affiliation  Government Medical College Nagpur 
Address  Pl. No. 82/2 Sadbhavna Nagar Manewada Ring Road Nagpur.
Government Medical College Nagpur Hanuman Nagar Nagpur
Nagpur
MAHARASHTRA
440027
India 
Phone  9582414799  
Fax    
Email  amit22gmcnagpur@gmail.com  
 
Source of Monetary or Material Support  
National Board Of Examinations Ansari Nagar East New Delhi - 110029 
 
Primary Sponsor  
Name  Vardhaman Mahavir Medical College and Safderjung Hospital 
Address  Ansari Nagar West New Delhi 
Type of Sponsor  Government medical college 
 
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 
AMIT WANKHEDE  VMMC AND SAFDARJANG HOSPITAL  ANSARI NAGAR WEST NEW DELHI
New Delhi
DELHI 
9582414799

amit22gmcnagpur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GOVERNMENT OF INDIA INSTITUTE ETHICS COMMITTEE SAFADARJANG HOSPITAL AND VMMC NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA GRADE I,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  All patients in study were of American Society Of Anesthesiology (ASA) Grade I in the age group of 1-10 years of either sex posted for video-endoscopic surgery.  
 
ExclusionCriteria 
Details  1. Patients with known cardiovascular, respiratory or neurological diseases.
2. Patients having upper respiratory tract infection.
3. Patients with coagulation disorders.
4. Patients subsequently converted to open surgical procedure in intraoperative period.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Both Proseal LMA and Endotracheal tube can be safely used, proseal being better choice.  5 min before insertion of an airway device : t0
5 min after insertion of an airway device : t1
5 min before insufflation of CO2 : t2
15 min after insufflation of CO2 : t3
30 min after insufflation of CO2 : t4
5 min after desufflation of CO2 : t5
5 min after removal of airway device : t6. 
 
Secondary Outcome  
Outcome  TimePoints 
Multi-centric studies with much larger sample of subjects and ethnicity are needed for validation of the concluded results.  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2014 
Date of Study Completion (India) 14/02/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Yet to be published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Aims and Objectives: To study the effect of pneumoperitoneum on hemodynamic and respiratory parameters using Proseal LMA and endotracheal intubation and compare risk and benefits of using these two devices for video-endoscopic surgeries in children. 

Method: Total 60 ASA grade I children of either sex in the age group of 1-10 years were assigned randomly into two groups of 30 patients in each. Group I - Consists of patients airway secured with Proseal LMA and Group II - Consists of patients airway secured with endotracheal tube. Haemodynamic parameters such as HR, SBP, DBP, MBP, ECG and various respiratory parameters such as SpO2, EtCO2, PIP and PP were recorded during the study period. 

Results: We found that HR, SBP, DBP, MAP increased significantly following ETT intubation as compared to response after PLMA insertion. There were similar changes observed in haemodynamic parameters during and after insufflation period in both the group. No significant changes observed in SpO2 throughout study but EtCO2, PIP, PP showed significant changes after insufflation and 5 min after desufflation in both the groups. There intergroup comparisons were analogous; however return of EtCO2 towards baseline was quite delayed in ETT as compared with PLMA. PIP and PP return towards normal was earlier in ETT group than PLMA group. 

Conclusion: Both PLMA and ETT can be safely used, PLMA can be a better choice as it doesn’t evoke any intubation response, return of EtCO2 earlier towards baseline than ETT and not showed any added complication to ETT intubation.  

 
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