| CTRI Number |
CTRI/2024/04/065715 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| 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
|
To study the occurrence of stomach insufflation with air while administering general anaesthesia using two different ventilation techniques in obese patients. |
|
Scientific Title of Study
|
Comparison of gastric insufflation produced during conventional versus modified face mask ventilation during induction of general anaesthesia in obese patients undergoing elective surgery: A prospective randomised double blinded study. |
| 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 Ghansham Biyani |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Room No 1052, Department of Anaesthesiology, Main OT Complex, 1st Floor, IPD Building, AIIMS Mangalagiri, Guntur
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8764439671 |
| Fax |
|
| Email |
ghanshambiyani100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghansham Biyani |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Room No 1052, Department of Anaesthesiology, Main OT Complex, 1st Floor, IPD Building, AIIMS Mangalagiri, Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8764439671 |
| Fax |
|
| Email |
ghanshambiyani100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanga |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Department of Anaesthesiology, Main OT Complex, 1st Floor, IPD Building, AIIMS Mangalagiri, Guntur
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9384524945 |
| Fax |
|
| Email |
priyangassiva@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Mangalagiri, Guntur, AP, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical Sciences, Mangalagiri |
| Address |
Department of Anaesthesiology,
Main OT Complex, IPD builiding, All India Institute of Medical Sciences, Mangalagiri, Guntur, AP, 522503
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| None |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrGhansham Biyani |
All India Institute of Medical Sciences |
Department of Anaesthesiology, Main OT Complex, IPD builiding, All India Institute of Medical Sciences, Mangalagiri, Guntur, AP, 522503
Guntur
ANDHRA PRADESH |
8764439671
ghanshambiyani100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Mangalagiri, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional face mask ventilation technique |
After induction of general anaestehsia, face mask ventilation will be provided using volume-controlled mode of mechanical ventilation with a Tidal volume of 08 ml/kg of Ideal Body Weight and respiratory rate of 16 breaths/min for 3 minutes. |
| Intervention |
Modified face mask ventilation technique |
After induction of general anaestehsia, face mask ventilation will be provided using volume-controlled mode of mechanical ventilation with a Tidal volume of 04 ml/kg of Ideal Body Weight and respiratory rate of 8 breaths/min for 3 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Obese patients having BMI between 30 to 49.9 kg/m2
ASA physical status II and III
Age between 18 to 65 years of either sex
Adequate fasting status (6h for solids and 2h for clear liquids)
|
|
| ExclusionCriteria |
| Details |
Patients having comet tail appearance prior to induction (baseline)
Failure to obtain clear ultrasonographic images
Drugs affecting the dynamics of gastrointestinal system
History of esophageal or gastrointestinal trauma or surgery
Failed facemask ventilation in either group (An experienced anaesthetist fails to maintain SpO2 of above 90% using 100% O2 with bag and mask ventilation with two hand techniques and use of oral airway)
More than one attempt at endotracheal intubation
Esophageal intubation
Occurrence of gastric content regurgitation or aspiration
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients who develop a new ‘comet tail sign’ suggestive of gastric insufflation after induction compared to preinduction |
At 0 and 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in cross sectional area (CSA) of gastric antrum (measured using gastric ultrasound) and gastric volume (calculated using Bouvet equation) after induction compared to preinduction |
At 0 and 10 minutes |
| Change in arterial partial pressure of oxygen (PaO2), carbon dioxide (PaCO2), pH value and bicarbonate (HCO3-) at T1, T2 and T3 time intervals |
At 0, 2 and 5 minutes |
| Postoperative symptoms suggestive of gastric distention (bloating, burping, flatulence) and Post-operative Nausea and Vomiting (PONV) |
At 0 and 1 hour |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/05/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Peri-operative aspiration of gastric contents is a rare but serious
complication under general anaesthesia (GA). Aspiration of gastric contents can result in chemical pneumonitis, atelectasis,
ventilation – perfusion mismatch, acute respiratory distress syndrome amongst
others. Conventional
face mask ventilation (FMV) during induction of GA may result in insufflation
of air in to the gastric antrum leading to gastric distention. Therefore, rapid
sequence induction (RSI) is commonly used in patients who are at risk of
aspiration of gastric content like obese patients, pregnancy, patients with
intestinal obstruction, etc.
Obese patients (Body Mass Index
> 30 Kg/m2) are more prone to pulmonary aspiration compared to
patients with normal BMI. This is mainly due to difficult bag and mask
ventilation (BMV) resulting in higher gastric insufflation, and increased
intraabdominal pressure. It has been shown that conventional FMV used during the
induction of anaesthesia puts obese patients at risk of aspiration by causing
insufflation of air into the stomach.On the other hand, obese patients may not achieve adequate oxygenation
with spontaneous preoxygenation technique, putting them at risk of rapid
desaturation. Hence, a modified FMV technique which would provide adequate
oxygenation without putting these patients at risk of aspiration is ideal. Gastric ultrasound (US) has emerged as a non-invasive point of care diagnostic
tool which allows for both qualitative detection and quantitative estimation of
gastric volume with high sensitivity and specificity. In this trial, we would like to compare the effect
of conventional FMV (Tidal volume of 08 ml/kg and respiratory rate of 16
breaths/min) vs modified FMV (Tidal volume of 4 ml/kg and respiratory rate of 8
breaths/min) technique on gastric insufflation assessed by using gastric
ultrasound during induction of GA in obese patients undergoing elective
surgery. Our hypothesis is that modified
face mask ventilation technique is superior to conventional face mask
ventilation technique in terms of causing lesser gastric insufflation in obese
patients without having any deleterious effects on oxygenation and ventilation.
|