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The effect of a Sigh on ventilator weaning after Cardiothoracic surgery

The effect of a Sigh on ventilator weaning after Cardiothoracic surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000330741
Acronym
SIGH-CTSU
Enrollment
160
Registered
2022-02-22
Start date
2022-06-01
Completion date
2023-04-07
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will explore the impact that a sigh breath will have on ventilator weaning in post cardiac-bypass patients. Cardiac -bypass (a form of extra-corporeal support ) is utilised to allow Cardiothoracic surgeons to operate on the heart for a variety of procedures. Due to the complexity of the case and the impact of bypass on patients, these patients remain intubated at completion of the operation. Weaning from the ventilator occurs in ICU. Patients are required to be haemodynamically stable, with minimal respiratory support before being extubated. A sigh breath (a type of recruitment manoeuvre characterised by a high volume inspiration) has been shown to improve respiratory mechanics. It is hypothesised that patients who take a sigh breath as part of their assisted mode of ventilation will be able to be weaned off of a ventilator quicker. This study will introduce a sigh breath to a randomised sample of elective Cardiothoracic patients in order to demonstrate improvement in the primary outcome “Time to Weaning from mechanical ventilation”. It will examine for secondary outcomes like adverse effects, re-intubation rates and other physiological parameters. Mechanical ventilation is instituted in a variety of patients for respiratory support, to allow for certain procedures, for airway protection (e.g. in Traumatic brain injury). Mechanical ventilation is not without its dangers with longer periods of ventilation associated with increased risks. Clinicians routinely aim to extubate patients as soon as safely possible to mitigate these adverse effects. If Sigh ventilation can be shown to aid in a shorter duration of ventilation in this subset of patients , it may allow for further study into Sigh ventilation’s efficacy in other ventilated patient groups._x000C_

Interventions

Addition of a Sigh breath in Assisted ventilation 1 Sigh every minute. Characteristic of Sigh breath :30cmH20 over 3 secs. Remaining breaths will be pressure-supported. Utilisation of standard hospital ventilator available (Currently Puritan Bennet 980) Nursing staff will setup the ventilator as per specific Ventilator setup card in order to administer the intervention . Nursing staff and Treating clinicians will be able to modify the ventilator as required (including ceasing the interventio

Addition of a Sigh breath in Assisted ventilation 1 Sigh every minute. Characteristic of Sigh breath :30cmH20 over 3 secs. Remaining breaths will be pressure-supported. Utilisation of standard hospital ventilator available (Currently Puritan Bennet 980) Nursing staff will setup the ventilator as per specific Ventilator setup card in order to administer the intervention . Nursing staff and Treating clinicians will be able to modify the ventilator as required (including ceasing the intervention if patient condition changes (e.g. requires mandatory mode of ventilation) The duration of the intervention will be for the duration of mechanical ventilation in an assist mode of ventilation. If a patient is weaned and extubated, the intervention will cease. if a patient is changed to a mandatory mode of ventilation and subsequently moved back to assist mode , they will be given the intervention again if randomised to that group initially. There will be daily checks with patient nursing staff and treating team by research team/ ICU research officer to ensure compliance and understanding. After extubation , intervention compliance will be reviewed by Research team .

Sponsors

Flinders Medical Centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Elective Cardiac surgery On-pump procedure (undergoing Cardiopulmonary bypass) Patient from Home prior to surgery

Exclusion criteria

Age < 18 years Hx of COPD/Bulla Pneumothorax clinically On extracorporeal support Not planned for extubation in next 48 hours due to other issues requiring intubation (e.g Respiratory failure, further operative plans)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026