| 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
|
|
|
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
|
|
|
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
|
|
|
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 |
|
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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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