Fasting Durations Before Bronchoscopy And The Discomfort Levels Of Patients

January 12, 2025 updated by: National Taiwan University Hospital

Association Between Different Fasting Durations Before Bronchoscopy And The Discomfort Levels Of Patients Around The Procedure

The goal of this clinical trial is to learn if patients feel more comfortable while being placed on contemporary fasting principle than on conventional fasting time during flexible bronchoscopy. The main questions it aims to answer are:

To compare the thirty levels between patients with conventional fasting time (≥ 8 hours) and those with contemporary fasting principle (clear fluids for up to 2 hours before anesthesia) during flexible bronchoscopy To compare the levels of mucosal dryness between two groups of patients during flexible bronchoscopy To compare the levels of hunger between two groups of patients during flexible bronchoscopy To compare the levels of tiredness between two groups of patients during flexible bronchoscopy To compare the levels of fatigue between two groups of patients during flexible bronchoscopy To compare the levels of nausea/vomiting between two groups of patients during flexible bronchoscopy

Participants will:

Being placed on fasting either using conventional fasting time (≥ 8 hours) or with contemporary fasting principle (clear fluids for up to 2 hours before anesthesia) Being asked to respond to questions regarding thirsty, mucosal dryness, hunger, tiredness, fatigue, and nausea/vomiting in a visual analogue scale of 0 to 10

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • planned flexible bronchoscopy

Exclusion Criteria:

  • tracheostomy or intubated
  • known to be pregnant
  • significant functional or structural abnormalities of the gastrointestinal tract
  • oral intake prohibited and infeasible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: contemporary fasting principle
Other: contemporary fasting principle
(clear fluids for up to 2 hours before anesthesia)
Active Comparator: conventional fasting time
Other: conventional fasting time
(≥ 8 hours)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient thirty level
Time Frame: right before the bronchoscopy procedure
using a visual analogue scale of 0 to 10
right before the bronchoscopy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient mucosal dryness
Time Frame: right before the bronchoscopy procedure
using a visual analogue scale of 0 to 10
right before the bronchoscopy procedure
patient hunger
Time Frame: right before the bronchoscopy procedure
using a visual analogue scale of 0 to 10
right before the bronchoscopy procedure
patient tiredness
Time Frame: right before the bronchoscopy procedure
using a visual analogue scale of 0 to 10
right before the bronchoscopy procedure
patient fatigue
Time Frame: right before the bronchoscopy procedure
using a visual analogue scale of 0 to 10
right before the bronchoscopy procedure
patient nausea
Time Frame: right after the bronchoscopy procedure
using a visual analogue scale of 0 to 10
right after the bronchoscopy procedure
patient vomiting
Time Frame: right after the bronchoscopy procedure
absent or present
right after the bronchoscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 12, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 202412025RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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