Oral Fluid Intake After Extubation

Early Versus Delayed Oral Fluid Intake Initiation (Sipping) After Extubation, Influence on the Feeling of Thirst, Patient Comfort and the Occurrence of Complications.

According to the current guidelines the patient is not allowed to drink any fluid at least 2 hours after extubation to prevent complications. However there is no evidence in the literature to support this approach. Because anaesthetic drugs and their side effects changed significantly from their first usage, the investigators can assume that existing approach is obsolete and has no place anymore in the modern medicine. Keeping patient n.p.o (nothing per os) for 2 hours after extubation may lead to patient´s thirst or other discomfort. The aim of the study is to detect whether early oral fluid intake after extubation could lead to safe relief of thirst and to better patient´s comfort overall.

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Behavioral: Fluid intake not as per standard guidlines

Detailed Description

Everything stated in the brief summary.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Prague, Czech Republic, Czechia, 15006
      • University Hospital Motol, Charles University in Prague

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with planned extubation assigned to the study
• able to swallow the fluid
• willing to participate the study

Exclusion Criteria:

• patients after upper digestive tract surgery
• patients after trachea surgery
• patients with possible neurological deficiency
• patients after VIII. cranial nerve surgery
• patients not able to swallow

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early fluid intake	Behavioral: Fluid intake not as per standard guidlines; The participant will be randomized into two arms. After the randomization one arm will get the per os fluid intake before the standard time frame.
Other: Standard Delayed oral fluid	Behavioral: Fluid intake not as per standard guidlines; The participant will be randomized into two arms. After the randomization one arm will get the per os fluid intake before the standard time frame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of presence or absence of thirst 120 minutes after extubation	Between both groups the presence of anpleasent feeling of thirst will be assessed and compared	During procedure (120 minutes after extubation)

Collaborators and Investigators

• Sponsor: University Hospital, Motol

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): October 16, 2024
• Study Completion (Actual): October 16, 2024

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: April 15, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EK-1381/22

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