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A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters

NCT ID: NCT05883332

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-03-09

Brief Summary

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A urodynamic study (UDS) is a common procedure done to learn more about the cause of urinary symptoms. For some patients, UDS can be associated with anxiety or discomfort. Nitrous oxide (or laughing-gas) is a well-known sedative which is frequently used in dental offices and for pediatric procedures to reduce anxiety and pain. This study is being done to see if giving low-dose (25-50%) nitrous oxide at the time of UDS affects the measurements taken during the procedure, such as how much volume your bladder can hold, and pressures during urination. If the measurements are the same with and without self-administered nitrous oxide (SANO), it could be suggested that nitrous oxide may be a useful way of reducing patient anxiety and pain during UDS.

Detailed Description

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The urodynamic study (UDS) procedure will consist of catheter placement and two "runs". Before the start of the procedure, a study staff member will assist the participant with putting on a plastic gas mask. SANO and oxygen will be given through this mask. The dose will be adjusted based on the participant's comfort level but they will not be able to request more gas than allowed. SANO will be administered during catheter placement at the start of the UDS. During the two runs, the participant will either receive SANO (run 1) then oxygen (run 2), or oxygen (run 1) then SANO (run 2).

Before the day of the UDS, participants will be asked questions related to demographics and medical history to determine study eligibility and experience of the treatment. During the UDS, participants will be asked to describe their anxiety and pain levels. Afterwards, they will be asked to complete a 15-20 minute structured interview with a study staff member to learn more about patient experience during UDS.

Conditions

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Lower Urinary Tract Symptoms

Keywords

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urodynamic study nitrous oxide neurogenic bladder overactive bladder ambulatory patient experience of care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will undergo urodynamic study (UDS) with two fills. The participant will receive SANO during one fill, and oxygen during the other fill. Participants will be randomized to the order in which they receive SANO or oxygen.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The participant and operating urodynamic study practitioner will be blinded to whether SANO or oxygen is given during the study fills. UDS measurements will be assessed by a blinded urologist.

Study Groups

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SANO (1), Oxygen (2)

All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.

At the start of the first UDS run, SANO will continue at the participant-preferred level that was determined during catheter placement, ensuring that the patient is relaxed but still conversant through the procedure.

At the end of the first UDS run, SANO will be turned down to 0%. Participants will then receive 100% oxygen at 10 liters/minute for the duration of their second UDS run.

Group Type EXPERIMENTAL

Self-Administered Nitrous Oxide

Intervention Type DRUG

Nitrous oxide administered at concentrations of mild sedation (20-50%)

Oxygen

Intervention Type OTHER

100% oxygen at 10 Liters/minute

Oxygen (1), SANO (2)

All participants will receive self-administered nitrous oxide (SANO) at a range of 25-50% immediately before and during catheter placements. At this time, a participant-preferred level of SANO will be determined.

After catheter placement, SANO will be turned down to 0%. Participants will receive 100% oxygen at 10 liters/minute for the duration of their first UDS run.

At the end of the first UDS run, SANO will start at the participant-preferred level that was determined during catheter placement, ensuring that the patient is relaxed but still conversant through the procedure. SANO will be given for the duration of their second UDS run.

Group Type EXPERIMENTAL

Self-Administered Nitrous Oxide

Intervention Type DRUG

Nitrous oxide administered at concentrations of mild sedation (20-50%)

Oxygen

Intervention Type OTHER

100% oxygen at 10 Liters/minute

Interventions

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Self-Administered Nitrous Oxide

Nitrous oxide administered at concentrations of mild sedation (20-50%)

Intervention Type DRUG

Oxygen

100% oxygen at 10 Liters/minute

Intervention Type OTHER

Other Intervention Names

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nitrous oxide

Eligibility Criteria

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Inclusion Criteria

* Scheduled for urodynamic study
* Aged 21 to 85 years
* Suitable for inflation of nitrous oxide/oxygen with willingness to undergo two urodynamic study runs during the procedure
* Access to an email and computer

Exclusion Criteria

* Perioral facial hair impeding good mask seal
* Learning disabilities and/or inability to cognitively complete survey questions
* Has any of the following medical conditions:

1. Inner ear, bariatric or eye surgery within the last 2 weeks,
2. Current emphysematous blebs,
3. Severe B-12 deficiency,
4. Bleomycin chemotherapy within the past year,
5. Heart attack within the past year,
6. Stroke within the past year,
7. Class III or higher heart failure
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Heidi Rayala

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heidi Rayala, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Herd DW, McAnulty KA, Keene NA, Sommerville DE. Conscious sedation reduces distress in children undergoing voiding cystourethrography and does not interfere with the diagnosis of vesicoureteric reflux: a randomized controlled study. AJR Am J Roentgenol. 2006 Dec;187(6):1621-6. doi: 10.2214/AJR.05.1216.

Reference Type BACKGROUND
PMID: 17114560 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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2022P-000826

Identifier Type: -

Identifier Source: org_study_id