| CTRI Number |
CTRI/2024/04/066045 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate efficiency of pressure support ventilation in prolongation of safe apnea time in obese adults scheduled for elective surgery |
|
Scientific Title of Study
|
Comparative evaluation of preoxygenation using pressure support ventilation v/s conventional method in obese adults scheduled for elective surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priti |
| Designation |
Junior Resident Anaesthesia |
| Affiliation |
Pandit B.D.Sharma PGIMS Rohtak |
| Address |
Pt B.D.Sharma PGIMS Rohtak
Department of anesthesiology and critical care
Rohtak
HARYANA
124001
India |
| Phone |
8059478300 |
| Fax |
|
| Email |
preetivermapabra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susheela Taxak |
| Designation |
Consultant Anesthesiology and critical care |
| Affiliation |
Pandit B.D.Sharma PGIMS Rohtak |
| Address |
Pt B.D.Sharma PGIMS Rohtak
Department of anesthesiology and critical care
Rohtak
HARYANA
124001
India |
| Phone |
9896067416 |
| Fax |
|
| Email |
susheelataxak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priti |
| Designation |
Junior Resident Anaesthesia |
| Affiliation |
Pandit B.D.Sharma PGIMS Rohtak |
| Address |
Pt B.D.Sharma PGIMS Rohtak
Department of anesthesiology and critical care
Rohtak
HARYANA
124001
India |
| Phone |
8059478300 |
| Fax |
|
| Email |
preetivermapabra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Pt. B.D.Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BDSharma PGIMS Rohtak |
| Address |
Department of anesthesiology and critical care |
| 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 |
| Dr Priti |
Pt B.D. Sharma University of Health and Science |
Modular Operation theatre, department of anesthesiology and critical care
Rohtak
HARYANA |
8059478300
preetivermapabra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee pt B.D.Sharma PGIMS Rohtak |
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 |
| Comparator Agent |
Patient will be preoxygenated with conventional method |
Standardized anaesthesia
protocol will be followed.
Peripheral intravenous line will be secured with appropriate sized cannula.Appropriate size Arterial cannula will be secured for arterial blood gas analysis(BGA) under local anaesthesia.3 BGA sample will be withdrawn 1st base line sample,2nd at end of preoxygenation,3rd at SpO2 93%.Pre-oxygenation will be done through facemask applied tightly to face with 100% oxygen without pressure support. Fresh gas flow at 10L/min,inspiratory trigger 2l/min.Circuit will be flushed with O2 for 30sec before application to patient.End of preoxygenation will be at FeO2 90%.After that Induction of
anaesthesia will be done with
glycopyrrolate (0.005mgkg-1),
fentanyl (2µkg-1), thiopentone (5mgkg-1). Patient will breath spontaneously without pressure support during this period.After achieving
adequacy of ventilation,
neuromuscular blockade will be
achieved with rocuronium
(0.9mgkg-1). After 90sec of inj rocuronium administration intubation will be done under direct laryngoscopy and tube to kept open at atmosphere pressure and patient allowed to remain apneic till SPO2 fall to 93%(Safe apnea time).SpO2 will be measured every 15sec during this period.After that tube will be connected to breathing circuit and to be ventilated with 100% FiO2 for 3min. Further case will be managed as per standard protocol.Any adverse event during procedure will be managed as per standard guidelines.EtCO2,HR, Will be measured continuously as displayed on monitor and BP will be measured at interval of 3min.In post operative room patient will be asked for discomfort during preoxygenation as mild,moderate,severe. |
| Intervention |
Preoxygenation with 12cmH2O pressure support in intervention group |
Standardized anaesthesia
protocol will be followed.
Peripheral intravenous line will be secured with appropriate sized cannula.Appropriate size Arterial cannula will be secured for arterial blood gas analysis(BGA) under local anaesthesia.3 BGA sample will be withdrawn 1st base line sample,2nd at end of preoxygenation,3rd at SpO2 93%.Pre-oxygenation will be done through facemask applied tightly to face with 100% oxygen using pressure support of 12cmH2O without PEEP, Fresh gas flow at 10L/min,inspiratory trigger 2l/min.Circuit will be flushed with O2 for 30sec before application to patient.End of preoxygenation will be at FeO2 90%.After that Induction of
anaesthesia will be done with
glycopyrrolate (0.005mgkg-1),
fentanyl (2µkg-1), thiopentone (5mgkg-1). Patient will breath spontaneously with pressure support during this period.After achieving
adequacy of ventilation,
neuromuscular blockade will be
achieved with rocuronium
(0.9mgkg-1). After 90sec of inj rocuronium administration intubation will be done under direct laryngoscopy and tube to kept open at atmosphere pressure and patient allowed to remain apneic till SPO2 fall to 93%(Safe apnea time).SpO2 will be measured every 15sec during this period.After that tube will be connected to breathing circuit and to be ventilated with 100% FiO2 for 3min. Further case will be managed as per standard protocol.Any adverse event during procedure will be managed as per standard guidelines.EtCO2,HR, Will be measured continuously as displayed on monitor and BP will be measured at interval of 3min.In post operative room patient will be asked for discomfort during preoxygenation as mild,moderate,severe. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with age 20 to 60yr with BMI 25to 40, American society of anesthesiology ASA grade I and II with mallampati score I and II with thyromental distance more than 6cm |
|
| ExclusionCriteria |
| Details |
Patient refusal to participation
Difficult mask ventilation including bearded,edentulous
COPD, Bronchial Asthma,URTI
Pregnancy
Congenital heart disease
Coagulation and bleeding abnormalities
Breath holding less than 20 sec
Risk of aspiration |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients achieving EtO2 90% in 3min |
At 3min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preoxygenation time |
Time taken to achieve EtO2 90% |
| Effect on Safe Apnea time |
Time after 90sec of rocuronium administration to SpO2 fall to 93% |
| Discomfort during preoxygenation if any |
To be asked in postoperative room |
| Gastric insufflation if any |
During preoxygenation |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
30/04/2024 |
| 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="0"
Months="0"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Preoxygenation is a method of enriching blood with 100% oxygen inhalation for 3min before induction of general anaesthesia to prevent patient from hypoxia during intubation. Obese patients are more susceptible to hypoxia due decrease functional residual capacity. Preoxygenating obese patients with pressure support ventilation may help in prolongation of safe apnea time. We want to study effect of pressure support ventilation on preoxygenation is it shortens preoxygenation time, prolong safe apnea time, as it will be useful in emergency intubation and difficult intubation |