Comparing Maximal and Half-maximal Suction Pressure Applied During Water Exchange in Colonoscopy

Not Applicable

• Conditions: Minimally Sedated Patient Undergoing Colonoscopy
• Interventions: Procedure: maximal pressure; Procedure: half-maximal pressure; Device: Suction Unit

• Registration Number: NCT01948284
• Lead Sponsor: Dalin Tzu Chi General Hospital

Brief Summary

This prospective, randomize, controlled trial will compared maximal to half-maximal suction pressure applied during water exchange in patients undergoing minimally sedated colonoscopy. We test the hypothesis that maximal suction pressure is more efficient and causes shorter insertion time.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Status Verified: 2013-09
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-20
• Last Update Submitted: 2013-09-20
• Study First Posted: 2013-09-23
• Last Update Posted: 2013-09-23
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Patients undergoing minimally sedated colonoscopy performed by YHH

Exclusion Criteria

• known history of obstructive lesions of the colon,
• allergy to meperidine,
• massive ascites,
• past history of partial colectomy, or
• refusal to provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
maximal suction pressure	maximal pressure	The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg).
maximal suction pressure	Suction Unit	The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg).
half-maximal pressure	half-maximal pressure	The pressure level of the suction unit will be set at the half-maximal (-35 cm Hg).
half-maximal pressure	Suction Unit	The pressure level of the suction unit will be set at the half-maximal (-35 cm Hg).

Primary Outcome Measures

Name	Time	Method
cecal intubation time	30 minutes

Secondary Outcome Measures

Name	Time	Method
aspirated water amount	30 minutes
pain score	30 minutes
infused water amount	30 minutes
suction marks on the mucosa	30 minutes

Trial Locations

Locations (1)

Buddhist Dalin Tzu Chi General Hospital; 🇨🇳 Chia-Yi, Taiwan