| CTRI Number |
CTRI/2023/08/056277 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
07/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The comparison of positive pressure delivered at the end of expiration administered by a supra glottic airway device with no positive pressure delivered on severity of lung collapse during/after surgery under anaesthesia |
|
Scientific Title of Study
|
The effect of positive end-expiratory pressure administered by Proseal laryngeal mask airway on peri-operative atelectasis - A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Pangasa |
| Designation |
Assistant Professor Anesthesia |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room No.5011, 5th floor Teaching Block
AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810383313 |
| Fax |
|
| Email |
nehapangasa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Pangasa |
| Designation |
Assistant Professor Anesthesia |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room No.5011, 5th floor Teaching Block
AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810383313 |
| Fax |
|
| Email |
nehapangasa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Pangasa |
| Designation |
Assistant Professor Anesthesia |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room No.5011, 5th floor Teaching Block
AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810383313 |
| Fax |
|
| Email |
nehapangasa@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Sri Aurobindo Marg Ansari Nagar East, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences New Delhi |
| Address |
All India Institute Of Medical Sciences Sri Aurobindo Marg,Ansari nagar east
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Neha Pangasa |
All India Institute Of Medical Sciences |
Department of Anaesthesiology,Pain Medicine and critical care. Room No 5011
5th floor teaching block
New Delhi
DELHI |
9810383313
nehapangasa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS New Delhi |
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 |
| Comparator Agent |
NO Positive end expiratory pressure(No PEEP) |
NO PEEP will be applied for patients in Group Z.
After insertion of proseal LMA,All patients will be ventilated with Volume control mode of ventilation (VCV), setting a tidal volume (VT) of 6ml/kg predicted body weight (PBW). Respiratory rate will be set to maintain normocarbia (35 – 40 cm of H2O).
A PEEP of 8cmH2O will be given to patients in Group P (PEEP group) and no PEEP in Group Z |
| Intervention |
Positive end expiratory pessure(PEEP) |
A PEEP of 8cm H20 will be applied in patients of Group P.
PEEP will be applied after insertion of Proseal LMA till the patient is awake after general anesthesia. All patients will be ventilated with Volume control mode of ventilation (VCV), setting a tidal volume (VT) of 6ml/kg predicted body weight (PBW). Respiratory rate will be set to maintain normocarbia (35 – 40 cm of H2O). A PEEP of 8cmH2O will be given to patients in Group P (PEEP group) and no PEEP in Group Z |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients 18-65 years of age
Both male, female
ASA I and II
Posted for elective lower abdominal and urological surgery will be included
|
|
| ExclusionCriteria |
| Details |
Patients less than 18years and more than 65 years of age
ASA III and IV
Patients with any lung disease
Patients with cardiac disease
Obesity BMI>30 Kg/m2
Pregnancy
Anaemia Hb<7 g/dl
Anticipated difficult airway
Patients posted for laproscopic upper abdominal surgeries will be excluded
|
|
|
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 |
| To compare the loss of lung aeration (atelectasis) as measured by modified lung ultrasound score between the PEEP (8cm H2O) and No PEEP group. |
A: Baseline, before induction of anesthesia
B: 10 minutes following induction of general anesthesia
C: 1 hour following induction of general anesthesias
D: 30 minutes after removal of PLMA
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Gas leakage around the Proseal LMA(PLMA)
2.Peak inspiratory pressure (PIP) and dynamic compliance
3.PaO2/FiO2 ratio
4.Displacement or malpositioning of the PLMA |
1. Gas leakage will be determined built-in leakage detection system of ventilator and presence of audible gas leakage at 5min,30min and 60min after insertion of PLMA
2. The PIP and dynamic compliance (C-dy) will be noted from the ventilator at 5min and 30min after device insertion.
3. PaO2/FiO2(P/F) ratio will be noted at baseline, 1 hour following induction of general anesthesia and 30min postoperatively by obtaining arterial blood samples.
|
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/08/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nehapangasa@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To the best of our knowledge, the effect of PEEP
through LMA on lung atelectasis under general anesthesia is an area unexplored in literature. Lung ultrasound is an
excellent tool for rapid bedside assessment of perioperative atelectasis.
Hence we planned this study to compare the effect of PEEP
(8cm H2O) with No PEEP (ZEEP) applied through Proseal LMA (PLMA) on
lung atelectasis, studied by lung ultrasound in patients undergoing elective
lower abdominal and urological surgeries. |