Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial

Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial: A Randomized Controlled Feasibility Trial

The aim of this study is to evaluate the feasibility to perform a future larger clinical trial to analyze whether the mechanical ventilation reconnection for 1 hour after a successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in participants with more than 72 hours of mechanical ventilation. The study will compare two weaning strategies in critically ill participants admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial:

1. Reconnection to mechanical ventilation for 1 hour followed by extubation;
2. Direct extubation.

Follow-up will be until hospital discharge or death.

Study Overview

• Status: Recruiting
• Conditions: Airway Extubation; Ventilator Weaning
• Intervention / Treatment: Other: Direct extubation; Other: Reconnection to mechanical ventilation for 1 hour

Detailed Description

Objectives

The primary objective is to evaluate the feasibility to perform a future larger clinical trial to analyze whether the mechanical ventilation reconnection for 1 hour after a successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in participants with more than 72 hours of mechanical ventilation. Feasibility is defined as the capability to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental group (mechanical ventilation reconnection for 1 hour [+/-10 min] after spontaneous breathing trial followed by extubation) and control (extubation immediately after spontaneous breathing trial).

Secondary objectives are to analyze the effect of mechanical ventilation reconnection for 1 hour after a successful spontaneous breathing trial in participants with more than 72 hours of mechanical ventilation on the following outcomes: extubation failure, defined as a composite criterion of reintubation or death 7 days after extubation; days free of mechanical ventilation in 28 days; length of stay in the intensive care unit; length of hospital stay; intensive care unit mortality; hospital mortality.

Study design

This is a randomized clinical trial of feasibility, open multicenter, intention-to-treat. The investigators estimate the participation of 8 Brazilian intensive care units. The study will compare two weaning strategies from mechanical ventilation in critically ill participants admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial in pressure support or T-tube. Immediately following a successful spontaneous breathing trial, eligible participants will be randomized to mechanical ventilation reconnection for 1 hour followed by extubation or to immediate extubation. Reconnection to mechanical ventilation is defined as a return to the mechanical ventilation parameters prior to the spontaneous breathing trial. Follow-up will be until hospital discharge or death.

Randomization

Participants with consent to participate in the study and who meet the inclusion criteria will be randomized into two groups, which will undergo two different interventions:

1. Reconnection to mechanical ventilation for 1 hour after successful spontaneous breathing trial followed by extubation
2. Direct extubation after successful spontaneous breathing trial

A randomization list will be generated using a statistics package. Randomization will be in blocks of variable size and stratified by center and risk of extubation failure before spontaneous breathing trial. A participant who presents one or more criteria will be defined as high risk for reintubation: age > 65 years; presence of congestive heart failure as the cause of intubation; moderate or severe chronic obstructive pulmonary disease; Acute Physiology and Chronic Health Evaluation II (APACHE II) > 12 or Simplified Acute Physiology Score 3 (SAPS 3) > 50 on the day of extubation; body mass index > 30 (calculated as weight in kilograms divided by height in meters squared); presence of ≥ 2 comorbidities; ineffective cough or abundant secretion in the airways (> 2 aspirations in 8 hours before extubation); failure in more than one spontaneous breathing trial; mechanical ventilation for > 7 days, and; upper airway problems (including risk of developing laryngeal edema).

Randomization will be obtained using computerized tables of random numbers in blocks of four for each hospital and will be unknown to the investigators involved in participant recruitment. Randomization will be centralized via the internet using appropriate software (REDCap). The group to which the participant will be allocated will only be disclosed after the registration of the information in the electronic system. This prevents the investigator and medical staff from predicting which treatment group the participant will be allocated to. In the presence of an eligible participant, assistant's physiotherapists or intensivists will be directed to call a study staff member specifically responsible for randomization at each center. The randomization list will be generated by a statistician who will not participate in the study. As the intervention will be administered to critically ill participants on mechanical ventilation, it is not necessary to blind these participants. Because it is a non-pharmacological intervention, blinding the medical team is not feasible. There is no need for a committee to validate the outcome of the study (feasibility) and therefore the outcome evaluators will not be blinded.

Sample calculation

This is a study to assess feasibility with a convenience sample size of 60 participants. The investigators intend to include 30 participants after pressure support spontaneous breathing trial and 30 participants after T-tube spontaneous breathing trial.

Study variables and visits

Data will be collected by participating hospital's physiotherapist teams at bedside, recorded on a case report form, and transferred to an electronic form. Researchers will be trained for this specific task prior to the study. Only trained and authorized researchers will have access to study forms. Participants will be followed up until death or hospital discharge. For participants who are hospitalized for more than 90 days after randomization, follow-up will be truncated at 90 days. In such cases, participants will be considered to have been discharged alive.

Statistical analysis

Statistical analysis will be performed using the intention-to-treat principle. Adherence will be described by means of absolute frequencies and percentages. The effect of treatment on the outcome of extubation failure will be estimated using ratio of proportions and difference of proportions, and respective 95% confidence intervals.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aline Braz Pereira; Phone Number: +55 (47) 99181-8400; Email: linibp@hotmail.com

Study Locations

• Brazil
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89204-061
      • Recruiting
      • Centro Hospitalar Unimed de Joinville

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age > 18 years;
• Admission to the intensive care unit;
• Orotracheal intubation;
• Mechanical ventilation for more than 72 hours;
• Spontaneous breathing trial (according to the study protocol) successful and considered able to be extubated.

Exclusion Criteria:

• Patients unable to obey commands;
• Unplanned extubation;
• Neuromuscular disease and cervical spinal cord injury;
• Tracheostomy;
• Contraindication for cardiopulmonary resuscitation or reintubation;
• Absence of informed consent.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct extubation; The participant will be extubated immediately after the spontaneous breathing trial.	Other: Direct extubation; The participant will be extubated immediately after the spontaneous breathing trial.
Experimental: Reconnection to mechanical ventilation for 1 hour; As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.	Other: Reconnection to mechanical ventilation for 1 hour; As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups	Defined as the capability to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental group (mechanical ventilation reconnection for 1 hour [+/-10 min] after spontaneous breathing trial followed by extubation) and control (extubation immediately after spontaneous breathing trial).	At day of extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation failure within 7 days	Defined as a composite criterion of reintubation or death 7 days after extubation; Weaning failure will be defined as failure within 7 days after extubation requiring reintubation and invasive mechanical ventilation, whether post-extubation noninvasive ventilation was used or not. The choice of the composite outcome was made to consider possible participants who die before 7 days without being reintubated. The choice of time for the 7-day outcome was based on the fact that the time interval to define extubation success varies in the literature, and on the evidence that many participants are reintubated after 48-72 hours, making these times early to assess reintubation, especially in cases of prophylactic use of noninvasive ventilation or post-extubation high flow nasal cannula.	Up to 7 days after extubation
Ventilator-free days in 28 days	Defined as the number of days from the time of extubation and initiation of unassisted breathing to day 28 after randomization. If a participant dies before day 28, days without ventilation will be counted as zero. If a participant is reintubated and returned to mechanical ventilation and is later extubated again and remains on unassisted breathing through day 28, ventilation-free days will be counted from the end of the last assisted breathing period through day 28. One period of invasive mechanical ventilation lasting less than 24 hours and for the purposes of the surgical procedure will count as 1 day free of mechanical ventilation. Participants who are discharged from the hospital on unassisted breathing before 28 days will be considered ventilator-free for the remaining days up to 28 days.	Up to 28 days after randomization
Length of stay in the intensive care unit	Length of hospital stay from randomization to intensive care unit discharge	At ICU discharge, up to 90 days
Length of hospital stay	Length of hospital stay from randomization to hospital discharge	At hospital discharge, up to 90 days
Mortality in the intensive care unit	Mortality from randomization to intensive care unit discharge	At intensive care unit discharge, up to 90 days
Hospital mortality	Mortality from randomization to hospital discharge	At hospital discharge, up to 90 days

Collaborators and Investigators

• Sponsor: Centro Hospitalar Unimed de Joinville

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 12, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Ventilator Weaning; Rest; Airway Extubation
• Other Study ID Numbers: CHUnimed; 70984323.1.1001.5362 (Registry Identifier: Certificate of Presentation of Ethical Appreciation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No