| CTRI Number |
CTRI/2019/08/020811 [Registered on: 21/08/2019] Trial Registered Prospectively |
| Last Modified On: |
20/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of modes of ventilation in spine surgery in prone position. |
|
Scientific Title of Study
|
Comparison of pressure control ventilation with volume control ventilation in patients undergoing spine surgery in prone position. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renu Bala |
| Designation |
Professor |
| Affiliation |
Pt. B.D. Sharma PGIMS Rohtak (Haryana) |
| Address |
Department of Anaesthesiology and Critical Care,
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8901322251 |
| Fax |
|
| Email |
neurodmrenu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Godhwal |
| Designation |
Post Graduate Student |
| Affiliation |
Pt. B.D. Sharma PGIMS Rohtak (Haryana) |
| Address |
Department of Anaesthesiology and Critical Care,
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9968646162 |
| Fax |
|
| Email |
godhwalpoonam@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Godhwal |
| Designation |
Post Graduate Student |
| Affiliation |
Pt. B.D. Sharma PGIMS Rohtak (Haryana) |
| Address |
Department of Anaesthesiology and Critical Care,
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9968646162 |
| Fax |
|
| Email |
godhwalpoonam@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Instituitional, Pt. B. D. Sharma, PGIMS, Rohtak, Haryana,124001 |
|
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Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Pt. B.D. Sharma PGIMS Rohtak, Haryana - 124001 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poonam Godhwal |
Pt. B. D. Sharma, PGIMS, Rohtak |
Department of Anaesthesiology and Critical Care, Pt. B. D. Sharma, PGIMS Rohtak, Haryana. 124001
Rohtak
HARYANA |
9968646162
godhwalpoonam@yahoo.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C720||Malignant neoplasm of spinal cord, (2) ICD-10 Condition: D334||Benign neoplasm of spinal cord, (3) ICD-10 Condition: S220||Fracture of thoracic vertebra, (4) ICD-10 Condition: S320||Fracture of lumbar vertebra, (5) ICD-10 Condition: S331||Subluxation and dislocation of lumbar vertebra, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pressure control ventilation |
PFT will be performed using spirometer and FVC, FEV1 and PEFR will be noted preoperatively. In the operative room, all routine vital monitors will be attached and intravenous cannula will be secured. Radial artery cannulation will be done and sample will be drawn for ABG. Preoxygenation for 3 minutes will be done and induction of anaesthesia will be done with injection fentanyl 2 mcg per kg, thiopentone 3 to 5 mg per kg and vecuronium 0.12 mg per kg. After 3 minutes of bag and mask ventilation, airway will be secured with appropriate size endotracheal tube and patients will be mechanically ventilated with ventilator Primus Infinity empowered Drager Medical, Lubeck, Germany work station. Depending upon the randomization number, the patients will be allocated into either Group P i.e. PCV or Group V i.e. VCV. In group V, volume control mode will be used and settings will be tidal volume of 7 ml per kg, frequency of 10 to 20 to maintain EtCO2 of 35 to 40 mm of Hg, FiO2 of 0.4, inspiratory expiratory ratio of 0.5 and PEEP of 5 cm of H2O. In group P, pressure control mode will be set and peak airway pressure will be adjusted to achieve tidal volume of 7 ml per kg. Other parameters like frequency, FiO2, inspiratory expiratory ratio and PEEP will be same as in volume control mode. Following 5 minutes of ventilation in supine position, patient will be turned prone on chest and pelvic rolls such that the abdomen remains free and the patient will receive ventilation as in supine position. |
| Comparator Agent |
Volume control ventilation |
Maintenance of anaesthesia will be done using 0.40 O2, 0.60 N2O and isoflurane for 0.8 to 1 MAC. Fentanyl will be administered for intra operative analgesia and vecuronium for neuromuscular relaxation. Continuous monitoring for respiratory parameters i.e. minute ventilation, peak airway pressure, plateau pressure, dynamic compliance and haemodynamic parameters- HR, SBP, DBP and MAP will be done and recording will be done at 5 minutes after intubation, after prone, 30 minutes after prone, 60 minutes after prone, 90 minutes after prone, 120 minutes after prone and after turning the patient supine. The ABG analysis will be done 5 minutes after intubation, 30 minutes after prone, 60 minutes after prone and after supine position. Following parameters i.e. Static compliance, Dead space, Oxygenation, Oxygenation index, Alveolar and Alveolar arterial O2 difference will be derived. Following completion of surgery, neuromuscular blockade will be reversed with injection glycopyrrolate 0.01mg per kg and injection neostigmine 0.05 mg per kg. One day after surgery, PFTs and ABG will be repeated. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 60 years, of either sex, belonging to ASA physical status I – II scheduled to undergo thoracolumbar spine surgery (for tumors or trauma) in prone position under general anesthesia will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
Patients having Bronchopulmonary disease (like asthma, chronic bronchitis, emphysema), Cardiac disease, BMI >30 kg/m2, Cerebrovascular disease, Neuromuscular disorder and Multiple trauma will be excluded from the study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Respiratory mechanics (peak airway pressure, plateau pressure, lung compliance, dead space and oxygenation).
2. Pulmonary function tests (Vital capacity, Peak expiratory flow rate, forced expiratory volume in first second). |
Respiratory mechanics will be assessed for both pressure control and volume control ventilation intraoperatively. PFTs will be done preoperatively the same day as baseline, intraoperatively and one day postoperatively only. The above data will be compiled and appropriate statistical test will be used to analyse the results. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters (Heart rate, blood pressure, SpO2) |
The above outcome will be assessed for both pressure control and volume control ventilation intraoperatively only. Data will be compiled and appropriate statistical test will be used to analyse the results. |
|
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Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
30/08/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The aim and objectives of the thesis is comparison of two modes of mechanical ventilation – volume control and
pressure control in spine surgery patients in prone position. Adult patients aged 18 to 60 years, of either sex,
belonging to ASA physical status I – II
scheduled to undergo thoracolumbar spine surgery (for tumors or trauma) in
prone position under general anaesthesia will be enrolled in the study. Total of 74 patients (37 in each group) will be studied. Respiratory
mechanics (peak airway pressure, plateau pressure, lung compliance, dead space
and oxygenation), haemodynamic
parameters (heart rate, blood pressure) and pulmonary
function tests (vital capacity, peak expiratory flow rate, forced expiratory
volume in first second) will be assessed. Data will be compiled and appropriate statistical tests will be used to analyse the result.
|