NCT05819645

Brief Summary

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their side effects changed significantly from their first usage, the investigators can assume that existing approach is obsolete and has no place anymore in the modern medicine.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2024

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

January 6, 2023

Last Update Submit

October 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Early fluid intake

EXPERIMENTAL
Behavioral: Fluid intake not as per standard guidlines

Standard Delayed oral fluid

OTHER
Behavioral: Fluid intake not as per standard guidlines

Interventions

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.

Early fluid intakeStandard Delayed oral fluid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Motol, Charles University in Prague

Prague, Czech Republic, 15006, Czechia

Location

Related Publications (1)

  • Sedlackova S, Nigrovicova V, Peckova M, Durila M. Immediate "sipping" vs. delayed oral fluid intake after extubation: A randomized controlled trial. J Crit Care. 2026 Feb;91:155212. doi: 10.1016/j.jcrc.2025.155212. Epub 2025 Aug 7.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prf.

Study Record Dates

First Submitted

January 6, 2023

First Posted

April 19, 2023

Study Start

February 1, 2023

Primary Completion

October 16, 2024

Study Completion

October 16, 2024

Last Updated

October 21, 2024

Record last verified: 2024-10

Locations