| CTRI Number |
CTRI/2020/10/028398 [Registered on: 13/10/2020] Trial Registered Prospectively |
| Last Modified On: |
28/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Postural Impact on Gastric Ultrasound assessment In Pregnancy
|
|
Scientific Title of Study
|
Postural Impact on Gastric Ultrasound assessment In Pregnancy:
An Observational Study
|
| Trial Acronym |
PIGUP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yudhyavir Singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Department of Anaesthesia,Pain medicine,and Critical Care
All India Institute Of Medical Sciences
Ansari Nagar,
New Delhi 110029
South DELHI 110029 India |
| Phone |
|
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Soumya Sarkar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Department of Anaesthesia,Pain medicine,and Critical Care
All India Institute Of Medical Sciences
Ansari Nagar,
New Delhi 110029
South DELHI 110029 India |
| Phone |
8427483176 |
| Fax |
|
| Email |
soumyacmconline@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Soumya Sarkar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Department of Anaesthesia,Pain medicine,and Critical Care
All India Institute Of Medical Sciences
Ansari Nagar,
New Delhi 110029
DELHI 110029 India |
| Phone |
8427483176 |
| Fax |
|
| Email |
soumyacmconline@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Pain medicine and Critical care AIIMS New Delh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Pain medicine and Critical care AIIMS New Delhi |
| Address |
Department of Anaesthesiology Pain medicine and Critical care AIIMS New Delhi
Ansari Nagar
New Delhi 110029 |
| 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 |
| Dr Yudhyavir Singh |
All India Institute Of Medical Sciences,New Delhi |
Ansari Nagar
New Delhi 110029
South DELHI |
9811140057
yudhyavir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,All India Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
1.>18-year-old
2.Women with singleton pregnancy
3.Gestational age ≥ 36 weeks, not in active labour
4.Elective Cesarean Section
5.Pre pregnancy ASA physical status I & II
|
|
| ExclusionCriteria |
| Details |
1.Any mental disorder
2.Patient refusal
3.Emergency Caesarean Section
4.Pre pregnancy body mass index greater than 30
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of the impact of different positioning on qualitative assessment of gastric volume in non-labouring pregnant patients at term. |
An ultrasound assessment of the antrum will be done for the first time at 8 hours of solid and 2 hours for clear liquid fasting. Thereafter, the antrum area will be examined 10 mins after ingestion of 100 ml water. Subjects will be scanned in supine and right lateral position in a medical cot with the upper part at 0o, 30o and 45o. Each assessment will be performed 20 s after each change in bed and body position, and each to be completed within 40 s.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gastric emptying of clear fluid in pregnancy |
An ultrasound assessment of the antrum will be done for the first time at 8 hours of solid and 2 hours for clear liquid fasting. Thereafter, the antrum area will be examined 10 mins after ingestion of 100 ml water. Subjects will be scanned in supine and right lateral position in a medical cot with the upper part at 0o, 30o and 45o. Each assessment will be performed 20 s after each change in bed and body position, and each to be completed within 40 s. |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
02/11/2020 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
To be published when the study will be completed. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gastric physiology in pregnancy is not well understood. Conventionally all term pregnant women are treated as ‘full stomach’ with increased risk of aspiration due to upward displacement of the stomach by the gravid uterus, progesterone-induced relaxation of the lower oesophageal sphincter, and comparatively lower gastric ph. Gastric ultrasound has emerged as a useful point-of-care tool for pre-operative estimation of gastric contents and volume. However, gastric ultrasound is technically more challenging in pregnancy due to upward displacement of the stomach, the rotation of the stomach into a more horizontal position, and an increase in respiratory rate. Probe placement also becomes difficult due to the steep angle between the xiphoid and the abdomen. Gastric contents are affected by gravity and body position. The posture of the patient may influence the consistency and reliability of qualitative and quantitative ultrasound assessments It has been seen that raising the upper section of the bed significantly alters the assessment of gastric fluid contents using the Perlas qualitative grading scale in non-pregnant healthy adult volunteers. Thus, the primary objective of our study is to assess the impact of different positioning on qualitative assessment of gastric volume in non-labouring pregnant patients at term. |