Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 80 of 570 for:    CARBON DIOXIDE AND anesthesia

Safety and Efficacy of CO2 for Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287687
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Warren Bishop, University of Iowa

Brief Summary:

Hypothesis:

Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal distension and discomfort; it is equally effective as air in pediatric patients undergoing endoscopic procedures.

Aim 1:

Determine the occurrence and severity of abdominal discomfort and distension associated with endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4 hours after discharge in carbon dioxide group when compared to the air group.

Aim 2:

Determine if the expertise level of the endoscopist contributes to abdominal discomfort and distension following endoscopy, and whether this differs in the carbon dioxide group versus air group.

Aim 3:

Determine if carbon dioxide is as effective as air for insufflation.


Condition or disease Intervention/treatment Phase
Endoscopy Insufflation Drug: Carbon dioxide gas for insufflation Drug: Air Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded, placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Randomization will be done 1:1, double blinded. - Procedure nurse will randomly choose an envelope from a box; the envelope contains a card listing either "CO2" or "Air". The envelopes will be unmarked and will be prepared with an equal number of cards for each arm. The procedure nurse then turns on either CO2 or air insufflation according to the card in the envelope. The air/CO2 controls will be kept covered to preserve blinding of the endoscopist. She will also record the patient's arm allocation in a logbook, which will be kept in a locked cabinet.

  • These events will precede entry of the patient and endoscopist into the procedure room.
  • Therefore, all study participants are blinded and allocation is also blinded also.
Primary Purpose: Other
Official Title: The Safety and Efficacy of Carbon Dioxide for Insufflation During Endoscopy in Pediatric Patients
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : April 9, 2019
Actual Study Completion Date : April 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Air for insufflation
In this arm of patients, air which is currently used as standard of care will be used for insufflation
Drug: Air
Air is the standard of practice and will be used in the control arm

Experimental: Carbon dioxide gas for insufflation
in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy
Drug: Carbon dioxide gas for insufflation
Carbon dioxide gas use for insufflation during endoscopy instead of air
Other Name: CO2




Primary Outcome Measures :
  1. Change in abdominal pain and distention [ Time Frame: At initial study visit prior to the procedure and within four hours after the procedure ]
    Abdominal discomfort / pain and distention before and after endoscopy will be compared in both groups


Secondary Outcome Measures :
  1. Is carbon dioxide as effective as air for insufflation [ Time Frame: During procedure ]
    Endoscopists will be asked to rate the effectiveness of insufflation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric gastroenterology patients aged 6 months through 21 years undergoing endoscopic procedures in the Stead Family Children's Hospital (SFCH) Lower Level 2 procedure room or the operating room in the SFCH who willingly consent/ascent to the study. These procedures will range from Esophagogastroduodenoscopy, Colonoscopy, and those having both Esophagogastroduodenoscopy and Colonoscopy.

Exclusion Criteria:

  • Non English speaking families who require the services of a translator Children outside the stipulated age range of study. Children in foster care homes or wards of the court. Children and parents who do not willingly consent to the study Children with history of bronchopulmonary dysplasia or other chronic respiratory compromise.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287687


Locations
Layout table for location information
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Warren Bishop
Investigators
Layout table for investigator information
Principal Investigator: Warren P Bishop, MD University of Iowa

Publications of Results:
Layout table for additonal information
Responsible Party: Warren Bishop, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03287687     History of Changes
Other Study ID Numbers: 201706767
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No