NCT02619656

Brief Summary

The investigators hypothesize that using carbon dioxide for PEG placement versus using room air will decrease post-procedure pneumoperitoneum as well as improve post-procedure bloating/pain, and waist circumference.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

3.2 years

First QC Date

November 10, 2015

Last Update Submit

November 30, 2015

Conditions

Pneumoperitoneum

Keywords

PEGCO2 insufflationRoom Air insufflationpneumoperitoneum

Outcome Measures

Primary Outcomes (1)

  • Post-procedure pneumoperitoneum

    Frequency of post pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement.

    left-lateral decubitus abdominal x-rays 30 min after PEG placement.

Study Arms (2)

Treatment

EXPERIMENTAL

Patients randomized to insufflation with CO2. Intervention: CO2 Insufflation with CO2Efficient Endoscopic Insufflator on managed flow setting at 3.4 L/min

Procedure: CO2 insufflation

Control

ACTIVE COMPARATOR

Patients randomized to insufflation with ambient air. Intervention: Ambient air insufflation with Evis Exera 111 CLV-190 on medium air flow setting 0.68 L/min

Procedure: Ambient air insufflation

Interventions

CO2 insufflationPROCEDURE

Patients were randomized to insufflation with CO2.

Also known as: CO2Efficient Endoscopic Insufflator on flow setting 3.4L/min
Treatment
Ambient air insufflationPROCEDURE

Patients were randomized to insufflation with ambient air.

Also known as: Evis Exera 111 CLV-190 on medium air flow setting 0.68L/min
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah SOM

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Officials

  • Christopher Murphy, MD

    University of Utah SOM

    STUDY CHAIR

  • John C Fang, MD

    University of Utah SOM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Gastroenterology, Hepatology and Nutrition

Study Record Dates

First Submitted

November 10, 2015

First Posted

December 2, 2015

Study Start

April 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(1)