| CTRI Number |
CTRI/2022/11/047449 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
18/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ventilation strategy in patients undergoing Open Abdominal Surgeries in Trendelenburg position. |
|
Scientific Title of Study
|
Intraoperative Lung-protective ventilation strategy for patients undergoing open Abdominal surgeries in Trendelenburg position: A Randomized 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 |
Neeradi Vishal Kumar |
| Designation |
postgraduate |
| Affiliation |
Nizam’s Institute of Medical Sciences |
| Address |
Nizam’s Institute of Medical Sciences
Hyderabad TELANGANA 500082 India |
| Phone |
|
| Fax |
|
| Email |
vishalkumarneeradi7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shibany Padhy |
| Designation |
Associate Professor |
| Affiliation |
Nizam’s Institute of Medical Sciences |
| Address |
Nizam’s Institute of Medical Sciences
Hyderabad TELANGANA 500082 India |
| Phone |
|
| Fax |
|
| Email |
drshibanipadhy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Neeradi Vishal Kumar |
| Designation |
postgraduate |
| Affiliation |
Nizam’s Institute of Medical Sciences |
| Address |
Nizam’s Institute of Medical Sciences
Hyderabad TELANGANA 500082 India |
| Phone |
|
| Fax |
|
| Email |
vishalkumarneeradi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIZAM’S INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
NIMS |
| Address |
NIMS,PANJAGUTTA, HYDERABAD |
| 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 |
| Vishal Kumar |
Nizam’s Institute of Medical Sciences |
department of anaesthesia and intensive care, speciality block, room number 302,Punjagutta, Hyderabad Hyderabad TELANGANA |
8500209005
vishalkumarneeradi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraoperative lung protective ventilation |
Lung recruitment manoeuvres by applying step wise increase in PEEP 30min after intubaion,30min after abdominal retraction,60min before extubation and at extubation. Total duration of minimum 2hours |
| Comparator Agent |
Tidal volume of 8 to 10ml/kg, with no intraoperative PEEP and recruitment manoeuvres |
Tidal volume of 8 to 10ml/kg, with no intraoperative PEEP and recruitment manoeuvres. Total duration of minimum 2hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with 18-65years of age
2.either gender
3. patients undergoing elective open abdominal surgeries in trendelenburg position
4.surgery duration of greater than 2hours
5.American Society of Anesthesiologists (ASA) physical status I,II,III . |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate in the study
2.Preexisting significant cardiac or pulmonary co morbidities (heart failure, intractable shock, Chronic obstructive pulmonary disease, Asthma, pulmonary infection, bronchiectasis, pulmonary metastases)
3.Preexisting abnormalities on chest X-ray or spirometry.
4.History of neuromuscular disease
5.Liver cirrhosis (Child B or C), or chronic renal failure with hemodialysis, and the
6.Need to continue prolonged mechanical ventilation after surgery.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| intra- and postoperative changes in P/F. |
intra- and postoperative changes in P/F, PaO2 before induction, 1hour after intubation and postoperative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| differences between the two groups regarding PaO2, A-aO2; intraoperative Cdyn and Stat, and the incidence of atelectasis detected on chest x-ray on the first postoperative day. |
differences between the two groups regarding PaO2, A-aO2; intraoperative Cdyn and Stat after intubation,30min after intubation,60min before extubation and at extubation, and the incidence of atelectasis detected on chest x-ray on the first postoperative day. |
|
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Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
25/11/2022 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be sent for publication once the study is complete. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Extreme steep Trendelenburg position of 25-40 degrees could contribute to Atelectasis formation, particularly in dependent regions and elevate mechanical stress in pulmonary parenchyma, triggering significant perioperative pulmonary dysfunction. Administration of General Anesthesia further decreases the End -Expiratory lung volume (EELV) forming Atelectasis and leads to a deterioration in respiratory mechanics and gas exchange. Ventilation strategy employing high tidal volumes could over distend normal lungs, thereby activating a local inflammatory reaction. Furthermore , zero- positive end-expiratory pressure or low levels of positive end-expiratory pressure (PEEP) could induce repetitive collapse and reopening of Alveoli, which ultimately result in an inflammatory injury. In recent years , intraoperative lung-protective mechanical ventilation (LPV) has been reportedly able to attenuate ventilator- induced lung injuries (VILI) by employing a low tidal volume (Vt), an appropriate level of PEEP and recruitment maneuvers (RMs). In recent years, intraoperative lung-protective mechanical ventilation (LPV) has been reportedly able to attenuate ventilator-induced lung injuries (VILI) by employing a low tidal volume (Vt), an appropriate level of PEEP , and recruitment maneuvers (RMs) .The goals of these interventions are to minimize alveolar over distention, to prevent repeated collapse and reopening of alveoli and to reduce atelectasis. |