| CTRI Number |
CTRI/2021/04/033104 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of optimum positive end expritaory presssure on post-operative lung atelectasis in children |
|
Scientific Title of Study
|
Effect of optimum positive end expritaory presssure(PEEP) on post-operative lung atelectasis in children- A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Teyongtangla Imsong |
| Designation |
Junior Resident ( Academic) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of anaesthesiology, pain medicine and critical care. 5th floor , Academic Block , AIIMS
South
DELHI
110029
India |
| Phone |
9582503138 |
| Fax |
|
| Email |
teyongtangla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of anaesthesiology, pain medicine and critical care. 5th floor , Academic Block , AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drrakesh.kumar.akb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of anaesthesiology, pain medicine and critical care. 5th floor , Academic Block , AIIMS
West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drrakesh.kumar.akb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, pain medicine and critical care |
|
|
Primary Sponsor
|
| Name |
Deaprtment of anaesthesiology pain medicine and critical care |
| Address |
AIIMS, New Delhi, 110029 |
| 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 |
| Teyongtangla Imsong |
All India Institute of Medical Sciences |
Department of anaesthesiology, pain medicine and critical care, AIIMS, New delhi
South
DELHI |
9582503138
teyongtangla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C40||Malignant neoplasm of bone and articular cartilage of limbs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fixed positive end expiratory pressure (PEEP) |
fixed positive end expiratory pressure(PEEP) of 5cmH2O will be applied throughout surgery in the control group A |
| Intervention |
Optimum positive end expiratory pressure(PEEP) |
optimum positive end expiratory pressure(PEEP) will be applied based on best dynamic lung compliance. PEEP will be decreased by 2cmH2O from 20cmH20 at every 30 seconds interval till best lung compliance is achieved which will be calculated with Drager Primus anaesthesia workstation. The optimum PEEP will then be applied for the entire length of surgery in group B. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective major orthopaedic surgery in supine position
|
|
| ExclusionCriteria |
| Details |
1. Parental refusal to participate in the study.
2. Children with known severe lung disease.
3. Children with a history of severe lung infection having post infection sequelae in preoperative chest x-ray.
4. Children with known deformity of chest wall or thoracic spine.
5. Children undergoing spine surgery in prone or lateral position.
6. Children with pre-existing significant cardiac, renal or hepatic diseases.
7. Children with history of previous thoracic surgery.
8. Children with BMI > 30 kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the incidence of significant atelectasis defined as consolidation score 2 in any region in post operative lung ultrasound assessment. |
lung ultrasound images will be obtained at 4 predefined time points:
T-1 Before induction of general anaesthesia
T-2 Five minutes after intubation before lung recruitment
T-3 Before extubation
T-4 One hour after extubation in PACU (Post Anaesthesia Care Unit)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of lung ultrasound score with
PaO2 / FiO2 ratio
Body Mass Index
Alveolar-arterial oxygen gradient
Duration of surgery
Incidence of intraoperative hypotension and bradycardia in both groups.
Change in driving pressure during intraoperative period between both groups.
Change in lung compliance during intraoperative period between both groups.
Duration of oxygen supplementation required to maintain SpO2 94% in each group in the first postoperative day .
|
Hemodynamic monitoring,saturation: 15 minute intervals after induction
Respiratory mechanics:5 min after intubation,after lung recruitment,30 min interval intraoperatively,before extubation
ABG- after induction, before extubation, 1 hour after extubation in PACU
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/05/2021 |
| 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="2"
Months="0"
Days="23" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
General anaesthesia used during surgery predisposes patients to postoperative pulmonary compliacations which includes pneumonia, atelectasis, respiratory failure etc which increases the morbidity and mortality of patients postoperatively. Children are more susceptible because of their anatomical and physiological differences such as the decreased FRC due to the increased compliance of their chest wall which provided reduced counterbalance to the inward elastic recoil of the lugs. Application of lung recruitment manoeuver, appropriate PEEP thus becomes necessary to keep the alveoli open and maintain adequate oxygenation during the course of surgery. We hypothesize that an optimum PEEP based on best lung compliance can improve intraoperative oxygenation and thus reduce postoperative lung atelectasis as assessed by lung ultrasound score |