Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)

A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01321203

Enrollment

500

Registered

2011-03-23

Start date

2010-08-31

Completion date

2011-03-31

Last updated

2011-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Jaundice

Keywords

carbon dioxide insufflation

Brief summary

To assess the safety and efficacy of CO2 insufflations during ERCP 1. Primary objective: To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group. 2. Secondary objective: Endoscopist: * To assess the adequacy of bowel distension for adequate luminal visualization * To assess the peristaltic movement during the ERCP Anesthetist: * To measure the PCO2 level in patient post procedure. * To assess the amount of sedation required during the procedure. * To assess saturation and vital signs through out the procedure. * To assess requirement of buscopan.

Detailed description

mentioned in complete

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* All consecutive adult patients referred for ERCP to AIG Hyderabad

Exclusion criteria

* Age \< 18 years old excluded from the study. * Patients with COPD. * Patients with poor ejection fractions and decompensated heart failure. * Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments. * Patients with recent endoscopic procedure within 24 hours. * Patient with history of recent surgery within 7 days of duration. * Pregnant patients. * Patients not keen to give consent for the study.

Design outcomes

Primary

Measure	Time frame	Description
Patient comfort post ERCP	1 hour	the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )

Secondary

Measure	Time frame	Description
Abdominal distention prior and post ERCP	5 minutes	The abdominal girth was measured prior to patient shifted to ERCP table. The immdiately post ERCP the abdominal girth measured. A fixed point is marked at the umblical regiem to maintain the site of abdominal girth.

Countries

India

Outcome results