Fasting Durations Before Bronchoscopy And The Discomfort Levels Of Patients

NCT06779084 | Not Yet Recruiting

• 1 other identifier: 202412025RINA
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bronchoscopy; Fasting ( 6H for Solid ; 2H for Clear Fluid )

Outcome Measures

Primary Outcomes (1)

• patient thirty level

  using a visual analogue scale of 0 to 10

  right before the bronchoscopy procedure

Secondary Outcomes (6)

• patient mucosal dryness

  right before the bronchoscopy procedure

• patient hunger

  right before the bronchoscopy procedure

• patient tiredness

  right before the bronchoscopy procedure

• patient fatigue

  right before the bronchoscopy procedure

• patient nausea

  right after the bronchoscopy procedure

Study Arms (2)

contemporary fasting principle

EXPERIMENTAL

Other: contemporary fasting principle

conventional fasting time

ACTIVE COMPARATOR

Other: conventional fasting time

Interventions

contemporary fasting principle OTHER

(clear fluids for up to 2 hours before anesthesia)

contemporary fasting principle

conventional fasting time OTHER

(≥ 8 hours)

conventional fasting time

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• planned flexible bronchoscopy

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Chao-Chi Ho

CONTACT

+886-2-23562905; ccho1203@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01