Effect of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients

NCT03929328 | Unknown

• 1 other identifier: HOSTLSM2019
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is aimed to show a spontaneous breathing trial using high flow oxygen therapy may lower weaning failure rate and reintubation rate than using T-piece.

Conditions

Weaning; Mechanical Ventilation; Extubation

Outcome Measures

Primary Outcomes (1)

• Rate of weaning failure

  Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation

  Day 2

Secondary Outcomes (5)

• ICU mortality

  From the date of randomization until the date of ICU death from any cause, assessed up to 1 month.

• In-hospital mortality

  From the date of randomization until the date of in-hospital death from any cause, assessed up to 3 months.

• ICU length of stay

  Through the study completion, an average of 1 weeks

• Time to reintubation after extubation

  From the date of extubation until the date of reintubation, assessed up to 1 weeks.

• Rate of reintubation within 48 hr of extubation

  Day 2

Study Arms (2)

Spontaneous breathing trial with T-piece

NO INTERVENTION

Patients were randomized to undergo a spontaneous breathing trial with T-piece that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation.

Spontaneous breathing trial with high flow oxygen therapy

EXPERIMENTAL

Patients were randomized to undergo a spontaneous breathing trial with high flow oxygen therapy that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation.

Procedure: High flow oxygen therapy in spontaneous breathing trial

Interventions

High flow oxygen therapy in spontaneous breathing trial PROCEDURE

Patients were randomized to undergo a spontaneous breathing trial with high flow oxygen therapy that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation.

Spontaneous breathing trial with high flow oxygen therapy

Eligibility Criteria

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

You may qualify if:

• Adult patients aged 18 years or more, both gender
• Receiving endotracheal intubation and mechanical ventilation for more than 12 hours
• Recovery from the precipitating illness
• Weaning readiness according to the following criteria :
• Respiratory criteria :
• PaO2:FIO2 \>150 with FIO2 ≤0.4, PEEP \<8 cm H2O
• Arterial pH \>7.35
• Rapid shallow breathing index (RSBI) \< 105
• Maximum inspiratory pressure (MIP) \< -20 cm H20
• Clinical criteria :
• Absence of electrocardiographic signs of myocardial ischemia
• No vasoactive drugs, or vital signs are stable with using vasoactive drugs
• Heart rate \<140/min,
• Hemoglobin \>8 g/dL
• Temperature \<38°C

You may not qualify if:

• Tracheostomy status
• Decision to stop life-supportive therapies before enrollment

Sponsors & Collaborators

• Sang-Min Lee: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (2)

• Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.

  PMID: 17470624 BACKGROUND

• Lee HY, Lee J, Lee SM. Effect of high-flow oxygen versus T-piece ventilation strategies during spontaneous breathing trials on weaning failure among patients receiving mechanical ventilation: a randomized controlled trial. Crit Care. 2022 Dec 23;26(1):402. doi: 10.1186/s13054-022-04281-w.

  PMID: 36564808 DERIVED

Study Officials

• Sang-Min Lee, MD

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Sang-Min Lee, MD

CONTACT

82-02-2072-0833; sangmin2@snu.ac.kr

Hong Yeul Lee, MD

CONTACT

82-02-2072-1094; takumama@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2019
• First Posted: April 26, 2019
• Study Start: June 17, 2019
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)