| CTRI Number |
CTRI/2017/11/010592 [Registered on: 22/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pressure controlled ventilation with 5 vs 10 cm H2O in children undergoing laparoscopic surgery under general anaesthesia
|
|
Scientific Title of Study
|
Pressure controlled ventilation with 5 vs 10 cm H2O in children undergoing laparoscopic surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSoumya Sarkar |
| Designation |
Junior Resident |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CENTRE |
| Address |
HOUSE NO 98
SECTOR 11A
CHANDIGARH160011
Department of Anaesthesia and Intensive Care
PGIMER
Sector12
Chandigarh 160 012
Chandigarh
CHANDIGARH
160011
India |
| Phone |
8427483176 |
| Fax |
|
| Email |
soumyacmconline@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja Bhardwaj |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research Centre |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER
Sector12
Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009521 |
| Fax |
|
| Email |
neerja.bhardwaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neerja Bhardwaj |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER
Sector12
Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009521 |
| Fax |
|
| Email |
neerja.bhardwaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Intensive Care PGIMER |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Intensive Care PGIMER |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER
Sector 12 Chandigarh 160 012 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SoumyaSarkar |
PGIMER |
Department of Anaesthesia and Intensive Care
Level 4
Neheru Building
Sector 12
Chandigarh 160 012
Chandigarh
CHANDIGARH |
8427483176
soumyacmconline@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35||Acute appendicitis, children aged 2 to 10 years undergoing laparoscopic surgery, (2) ICD-10 Condition: K80||Cholelithiasis, (3) ICD-10 Condition: K40||Inguinal hernia, (4) ICD-10 Condition: N13||Obstructive and reflux uropathy, (5) ICD-10 Condition: Q53||Undescended and ectopic testicle, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
children of age 2 to 10 years and ASA physical status I or II undergoing laparoscopic procedures under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Children with predicted difficult intubation and ventilation
Acute respiratory tract infection
Severe/active cardiopulmonary disease
Previous H/O or family H/O malignant hyperthermia
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare and assess the effect of 5 & 10 cm H2O PEEP on oxygenation in children undergoing laparoscopic procedures under GA
|
T1: Baseline value with the patient in the supine position 2 minutes after tracheal intubation and stabilization on the ventilator.
T2: 2 minutes after insufflating CO2 to an intra-abdominal pressure of 12 mmHg.
T3: 1 hour After applying PEEP 5 or 10cm H20.
T4: After completing the surgical procedure with the patient returned to the supine position with the abdomen deflated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare and assess the effect of 5 & 10 cm H2O PEEP on ventilation and hemodynamicparameters in children undergoing laparoscopic procedures under GA
|
T1: Baseline value with the patient in the supine position 2 minutes after tracheal intubation and stabilization on the ventilator.
T2: 2 minutes after insufflating CO2 to an intra-abdominal pressure of 12 mmHg.
T3: 1 hour After applying PEEP 5 or 10cm H20.
T4: After completing the surgical procedure with the patient returned to the supine position with the abdomen deflated
|
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2017 |
| Date of Study Completion (India) |
06/10/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
to be done once the study completed. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
In recent times laparoscopic surgery has become the treatment modality of choice not only in adults but also in paediatric patients. Creation of carbon dioxide Pneumoperitoneum (Pnp)is an essential component of laparoscopic procedures.Increased intra abdominal pressure due to Pnp causes splinting and cephalad shift of diaphragm , which leads to absolute decrease in functional residual capacity, atelectasis , decreased lung compliance and increased ventilation perfusion mismatch.In paediatric patients due to small airway calibre, increased dead space ventilation there is increase chance of hypercarbia , acidosis and relative hypoxia. Pressure Controlled Ventilation uses a decelerating flow , which compensate any potential reduction in ventilation. it enables more homogenous distribution of tidal volume in all ventilated alveoli reducing the amount of atelectasis by an improved alveolar recruitment.The patients receives an appropriate volume independent of circuit compliance and nd changes in fresh gas flow/ leaks around endotracheal tube. Positive End Expiratory Pressure [PEEP] has been used to attenuate the fall in partial pressure of arterial oxygen that accompanies Pnp. The use of PEEP prevents alveolar atelectasis and cyclical recruitment ,improving lung compliance and correcting ventilation perfusion mismatch. There is no consensus regarding the ideal level of PEEP during laparoscopic surgery.
A study suggested that in adult laparoscopic cholecystectomy, application of 10 cm H2O PEEP during Pnp increases compliance and oxygenation, does not cause hemodynamic and respiratory complicationsand reduces the post operative stress response in comparison to external PEEP OF 5 cm H2O. NO comparison of various level of PEEP has been evaluated in children.Therefore the aim of the present study is to compare and asses the effect of 5 and 10 PEEP on oxygenation , ventilation and hemodynamic parameters in children undergoing laparoscopic procedures under general anaesthesia. |