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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
ASA GRADE I, |
|
Intervention / Comparator Agent
|
|
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. |