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CTRI Number  CTRI/2024/07/070745 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   The effect of applying pressure through the ventilator during general anaesthesia in the elderly  
Scientific Title of Study   Comparative observational study on the deflation point characteristics in the pressure volume loop during application of end expiratory pressure of geriatric patients with that of young patients during general anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sree Kumar E J 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Anaesthesiology, 6th floor, SRMC, Porur

Chennai
TAMIL NADU
600116
India 
Phone  8056564566  
Fax    
Email  sreekumardr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sree Kumar E J 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Anaesthesiology, 6th floor, SRMC, Porur


TAMIL NADU
600116
India 
Phone  8056564566  
Fax    
Email  sreekumardr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sree Kumar E J 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Anaesthesiology, 6th floor, SRMC, Porur


TAMIL NADU
600116
India 
Phone  8056564566  
Fax    
Email  sreekumardr@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sree Kumar E J 
Address  Department of Anaesthesiology, 6th floor, SRMC, Porur 
Type of Sponsor  Other [Principal investigator] 
 
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 
Sree Kumar E J  Sri Ramachandra Institute of Higher Education and Research  Department of Anaesthesiology, 6th floor, Medical Centre
Chennai
TAMIL NADU 
8056564566

sreekumardr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (other than clinical evaluation of drugs/procedures/devices/diagnostics/vaccines/herbal remedies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Geriatric age   The patients planned for surgery under general anaesthesia of the age more than 65 years and less than 85 years are chosen for application of serial PEEP (positive end-expiratory pressure) with a change in PEEP changing every 30 minutes for a total of 2 hours and to note changes in Pressure-volume loop during anaesthesia.  
Comparator Agent  Young age   The patients planned for surgery under general anaesthesia of the age more than 20 years and less than 40 years are chosen for application of serial PEEP (for (positive end-expiratory pressure) with a change in PEEP changing every 30 minutes for a total of 2 hours and to note changes in Pressure-volume loop during anaesthesia.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  ASA I to III patients undergoing general anaesthesia with endotracheal tube
Procedures of duration at least 90 minutes 
 
ExclusionCriteria 
Details  Chronic lung conditions
Age between 40 and 65 years
Laparoscopic surgeries, Upper abdominal surgery, Thoracic surgery
BMI more than 35 kg per m2
CAD with EF less than 45 %
Patients with glaucoma, increased intracranial pressures
Anticipated difficult airway, reactive airway
Post-induction hemodynamic instability 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the change in tangent angle at upper deflation point with serial PEEP in a pressure-volume loop during general anaesthesia.  After 30 minutes of application of PEEP 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the change radius of curvature at upper point of deflation  After 30 minutes of application of PEEP 
To measure the change in angle of tangents at lower point of inflation  After 30 minutes of application of PEEP 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/08/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The changes in the lung physiology of patients in the geriatric age group include a decrease in chest wall compliance, an increase in functional residual capacity with an increase in residual volume and reserve volume. As these changes necessitate the application of positive end-expiratory pressure (PEEP), it is important to know the ideal PEEP in this age group.  Intra-opeartive monitoring allows dynamic pressure-volume loop monitoring, which has been used to identify optimal positive end-expiratory pressure (PEEP). The LIP of the inflation limb has traditionally been accepted as the point at which significant recruitment occurs. Thus, the pressure at LIP was used as the optimal point to set PEEP. Rimensberger et al. (1999a) demonstrated in a rabbit model that significantly more alveolar units remained open with PEEP set above the UIP of the deflation limb compared with PEEP set at the LIP of the inflation limb. Albaiceta et al. (2004) showed in humans with CT that using the UIP of the deflation limb produced greater recruitment and aeration compared with using the LIP. Hence we planned to study if a safe PEEP can be provided in the geriatric age group using this principle. In patients fitting the criteria, after securing an endotracheal tube of appropriate size, the ventilation is provided by volume-controlled ventilation, with a tidal volume of 7 ml/kg of predicted body weight and a respiratory rate of 12 /minute. Inhalational anaesthetic is initiated to target a MAC of 1 at 1 l/min. The baseline spirometry loop is recorded after 10 minutes. Serial PEEP of 4, 7, 10 cm H2O are applied at 30 minute interval and then a PEEP of 4 cmH2O is applied at the end of 90 minutes. At the end of 30 minutes, the PV loops are recorded. At the end of surgery, patient trachea is extubated and patient is shifted to the post-anaesthesia care unit. The loops obtained are analysed for radius of curvature, angle of the tangent at the upper point of the deflation curve and the angle of the lower inflation line.

 
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