CTRI Number |
CTRI/2020/03/023887 [Registered on: 11/03/2020] Trial Registered Prospectively |
Last Modified On: |
27/02/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical study to see the effect of different ventilator settings on blood oxygen levels under general anesthesia |
Scientific Title of Study
|
Use of Proseal laryngeal mask airway with pressure controlled ventilation with positive end expiratory pressure in improving oxygenation in paediatric population |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Arpit Singh |
Designation |
Junior Resident |
Affiliation |
Maulana Azad Medical college and associated Lok nayak hospital |
Address |
Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi Bahadur Shah Zafar Marg
New Delhi Central DELHI 110002 India |
Phone |
9911962715 |
Fax |
|
Email |
hobbygator@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
U C Verma |
Designation |
Director Professor |
Affiliation |
Maulana Azad Medical college and associated Lok nayak hospital |
Address |
Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi Bahadur Shah Zafar Marg
New Delhi Central DELHI 110002 India |
Phone |
9968604211 |
Fax |
|
Email |
ucverma2k@gmail.com |
|
Details of Contact Person Public Query
|
Name |
U C Verma |
Designation |
Director Professor |
Affiliation |
Maulana Azad Medical college and associated Lok nayak hospital |
Address |
Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi Bahadur Shah Zafar Marg
New Delhi Central DELHI 110002 India |
Phone |
9968604211 |
Fax |
|
Email |
ucverma2k@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi |
|
Primary Sponsor
|
Name |
Department of Anaesthesiology and Intensive Care |
Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, 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 |
Arpit Singh |
Lok Nayak Hospital |
Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi Central DELHI |
9911962715
hobbygator@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group PEEP |
A PEEP of 5cm of H2O applied in pressure controlled mode of ventilation |
Comparator Agent |
Group ZEEP |
A PEEP of 0cm of H2O applied in pressure controlled mode of ventilation |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
8.00 Year(s) |
Gender |
Both |
Details |
1.American society of anesthesiologist (ASA) physical status I
2.Patients undergoing surgical procedures permitting the use of supraglottic devices |
|
ExclusionCriteria |
Details |
1.Any upper or lower respiratory infections, asthma, cystic fibrosis etc.
2.Patient at risk of aspiration.
3.Patient with anticipated difficult airway.
4.Patients with reduced lung compliance, obesity or those with musculoskeletal disorders.
5.Patient undergoing spine and thoracoabdominal surgeries.
6.Patients requiring surgeries in prone or lateral positions.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Partial pressure of O2 (PaO2) |
30 mins after the institution of positive end expiratory pressure |
|
Secondary Outcome
|
Outcome |
TimePoints |
Oropharyngeal seal pressure |
After successful placement of the Proseal LMA. |
Partial pressure of CO2 (PaCO2) |
30 mins after the institution of positive end expiratory pressure |
Arterial blood pH |
30 mins after the institution of positive end expiratory pressure |
Any co-relation between the fibre optic grading and the Partial pressure of O2 (PaO2) levels |
30 mins after the institution of positive end expiratory pressure |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/03/2020 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Endotracheal intubation or bag-and-mask ventilation have been the mainstays of airway management for several decades. In 1983, this changed with the invention of the laryngeal mask airway (LMA) which provided ease of placement and hands-free maintenance along with a relatively secure airway. LMA is increasingly being used in all patient population including children and has been found to be very safe and efficacious in various studies. In the paediatric age group, the outward recoil of the chest wall is low, but the inward lung recoil is similar to that of a young adult. As the Functional Residual Capacity (FRC) is the lung volume at which the outward recoil of the chest wall exactly balances that of the inward recoil of the lungs, this leads to a reduced FRC in children. In awake state, the FRC is maintained by mechanisms such as active diaphragmatic and intercostal expiratory tone, but under general anaesthesia the closing volume tends to increase and the functional residual capacity decreases resulting in atelectasis and subsequent decreased arterial oxygenation. The application of adequate tidal volumes and a positive end-expiratory pressure (PEEP) play an important role in counteracting this airway closure and atelectasis in paediatric patients under general anaesthesia. This is usually achieved by using an endotracheal tube. However the ProSeal LMA (PLMA) has been shown to form a more effective seal than the Classic LMA and can be used to deliver PEEP which may improve gas exchange in children.5.6 There are few studies evaluating the use of PEEP with a supraglottic airway device in the paediatric age group in an attempt to minimise small airway closure. Hence we thought it worthwhile to compare the use of PLMA for pressure controlled ventilation with and without PEEP for improving oxygenation in paediatric patients. |