Weaning Success in Different Weaning Strategies in Early Neurological Rehabilitation Patients - a Matched-pair Analysis

NCT05483244 | Completed

• 1 other identifier: Weaning Strategy
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To enable weaning from mechanical ventilation, two different strategies may be distinguished: continuous weaning and discontinuous weaning. There is a lack of evidence of the superiority of one of both strategies is currently weak among early neurological rehabilitation patients. To the best of our knowledge, only one study including stroke patients compared different weaning strategies and showed a significantly shorter duration of mechanical ventilation during continuous than during discontinuous weaning, which is in contrast to the results of the largest weaning study with patients on medical-surgical intensive care units. In addition, further inconsistent results were reported from studies with chronic obstructive pulmonary disease patients, which might be due to disease duration and/or duration of prior mechanical ventilation in the acute care hospital. This small number of studies with controversial results indicates that there is a considerable need for further research. The current study intended to compare the rehabilitation outcome of early neurological rehabilitation patients, weaned by different strategies (continuous vs. discontinuous) through a matched-pair analysis.

Conditions

Neurologic Disorder; Respiratory Insufficiency

Keywords

early neurological rehabilitation; weaning strategy; weaning success

Outcome Measures

Primary Outcomes (1)

• weaning success

  number of patients who could weaned sucessfully from mechanical ventilation

  through study completion, an average of 70 days

Secondary Outcomes (1)

• weaning duration

  through study completion, an average of 70 days

Study Arms (2)

discontinuous weaning group

Patients of the discontinuous weaning group were disconnected from the respirator during the spontaneous breathing phases which could then take place via taken directly to the heat moist exchanger, high-flow therapy and/or speaking valve without pressure support by the respirator.

Other: discontinuous weaning

continuous weaning group

In the case of continuous weaning, spontaneous breathing trial was supported by the respirator, but the positive endexpiratory pressure was lowered to an individual level (between 5 and 10 mbar) resulting in very little pressure support.

Other: continuous weaning

Interventions

discontinuous weaning OTHER

Each day, a respiratory therapist evaluated whether a spontaneous breathing trial could be performed. Patients of the discontinuous weaning group were disconnected from the respirator during the spontaneous breathing phases which could then take place via heat moist exchanger, high-flow therapy and/or speaking valve without pressure support by the respirator (spontaneous breathing trial with heat moist exchanger). Heart rate, respiratory rate, blood pressure and mental condition of the patient (i. e. stress, fear) were monitored carefully for five to ten minutes and the Rapid Shallow Breathing Index was calculated. If the patient could keep the Rapid Shallow Breathing Index stable under 105/min/l (without a significant increase) over five minutes, the spontaneous breathing trial was regarded as successful and the weaning could be started. The duration of spontaneous breathing trial was extended according to the individual situation of the patient.

discontinuous weaning group

continuous weaning OTHER

Each day, a respiratory therapist evaluated whether a spontaneous breathing trial could be performed. In the case of continuous weaning, spontaneous breathing trial was supported by the respirator, but the positive endexpiratory pressure was lowered to an individual level (between 5 and 10 mbar) resulting in very little pressure support (spontaneous breathing trial trial under continuous positive airway pressure condition). Heart rate, respiratory rate, blood pressure and mental condition of the patient (i. e. stress, fear) were monitored carefully for five to ten minutes and the Rapid Shallow Breathing Index was calculated. If the patient could keep the Rapid Shallow Breathing Index stable under 105/min/l (without a significant increase) over five minutes, the spontaneous breathing trial was regarded as successful and the weaning could be started. The duration of spontaneous breathing trial was extended according to the individual situation of the patient.

continuous weaning group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with neurological main diagnoses, who admitted to early neurological rehabilitation and are under mechanical ventilation.

You may qualify if:

• mechanical ventilation at admission to neurological rehabilitation
• weaned by a continuous or discontinuous weaning strategy

You may not qualify if:

• pre-existing mechanical ventilation before disease onset
• mixed weaning strategies (continuous and discontinuous) during weaning process

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead

Study Sites (1)

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

Location

Related Publications (4)

• Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.

  PMID: 7823995 BACKGROUND

• Teismann IK, Oelschlager C, Werstler N, Korsukewitz C, Minnerup J, Ringelstein EB, Dziewas R. Discontinuous versus Continuous Weaning in Stroke Patients. Cerebrovasc Dis. 2015;39(5-6):269-77. doi: 10.1159/000381222. Epub 2015 Apr 8.

  PMID: 25871403 BACKGROUND

• Vitacca M, Vianello A, Colombo D, Clini E, Porta R, Bianchi L, Arcaro G, Vitale G, Guffanti E, Lo Coco A, Ambrosino N. Comparison of two methods for weaning patients with chronic obstructive pulmonary disease requiring mechanical ventilation for more than 15 days. Am J Respir Crit Care Med. 2001 Jul 15;164(2):225-30. doi: 10.1164/ajrccm.164.2.2008160.

  PMID: 11463592 BACKGROUND

• Matic I, Danic D, Majeric-Kogler V, Jurjevic M, Mirkovic I, Mrzljak Vucinic N. Chronic obstructive pulmonary disease and weaning of difficult-to-wean patients from mechanical ventilation: randomized prospective study. Croat Med J. 2007 Feb;48(1):51-8.

  PMID: 17309139 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Simone B Schmidt, Dr.

  BDH-Klinik Hessisch Oldendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: November 20, 2021
• Primary Completion: January 28, 2022
• Study Completion: July 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-08

Locations

DE (1)