ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000942055

Ethics application status

Approved

Date submitted

19/10/2010

Date registered

4/11/2010

Date last updated

10/07/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

Direct extubation onto high flow nasal prongs post cardiac surgery versus standard treatment in obese patients with a body mass index (BMI) of >/= 30: A randomised controlled trial

Scientific title

Direct extubation onto high flow nasal prongs to prevent atelectasis post cardiac surgery versus standard treatment in patients with a BMI >/= 30: A randomised controlled trial

Secondary ID [1]

N/A

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atelectasis

Obesity

Cardiac surgery

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Cardiovascular

Other cardiovascular diseases

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

High flow nasal prongs, direct extubation post cardiac surgery
When the patient meets the extubation criteria of the unit, the patient will be extubated as per unit protocol. The patient will then receive treatment as per Protocol A (control) or B (treatment).

Protocol B (Treatment)
*Patient extubated directly onto HFNP which are humidified to 37 degrees prior to application
*Starting Flow rate set to 35 litres/min and titrated up to a maximum of 50 litres as determined by patient comfort
*Starting FiO2 prescribed by Intensivist
*Patient to remain on HFNP continuously for 8 hours – breaks allowed for nasal care or mobilization
*Flow rate and FiO2 may be titrated to maintain SpO2 > 95% during the treatment period
*HFNP will be removed at the end of the 8 hour period, or until no longer required as determined by the treating intensivist
*Other treatments (i.e. Drug therapy, physiotherapy, upright positioning, and early mobilisation) will be conducted as per standard unit protocol in consultation with the treating intensivist and cardiac surgeon

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Protocol A (Control)
*Respiratory management as per treating intensivist (Hudson mask or Nasal prongs at low flow rates and FiO2 directed by intensivist) until transfer to the ward
*Other treatments (i.e. Drug therapy, physiotherapy, upright positioning, early mobilisation) will be conducted as per standard unit protocol in consultation with the treating intensivist and cardiac surgeon

Control group

Active

Outcomes

Primary outcome [1]

Reduction in atelectasis post cardiac surgery

Timepoint [1]

Chest radiography will be performed on Day 1 and 5 post surgery and scored for severity of atelectasis using a validated scoring system (Radiological Atelectasis Score) by a radiologist who is blinded to patient identity and treatment

Secondary outcome [1]

Reduction in hypoxaemia (as measured by PaO2/FiO2 ratio)

Timepoint [1]

Pao2/Fio2 will be calculated from any arterial blood gases taken as part of clinical care during the first 24hrs from return from surgery

Secondary outcome [2]

Improvement in patient dyspnoea score

Timepoint [2]

Dyspnoea Visual Analogue Scale - measured at 1, 8 and 12 hours post extubation

Secondary outcome [3]

Reduction in Respiratory rate

Timepoint [3]

Respiratory rate will be collected hourly from the patient's observation sheet for the first 24 hrs after surgery.

Eligibility

Key inclusion criteria

Male or female >/= 18 years
BMI >/= 30
Post on-cardiopulmonary bypass cardiac surgery

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patient refusal
Patients requiring direct extubation onto NIPPV
Pneumothorax
Patients unable to tolerate HFNP
Those requiring tracheostomy
Patients extubated as part of end of life treatment

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients will be enrolled prior to surgery and randomly allocated direct extubation onto high flow nasal prongs or standard treatment at 30-60 minutes prior to extubation. The randomised groups will be written in numbered ordered opaque envelopes prepared by the statistician. It will not be possible to blind the patient, clinical staff or study staff to the treatment allocation. The statistician and radiologist will be blinded to treatment allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be achieved through a computerised random number generator. A randomised list will be created by the statistician (using Excel). The randomised groups will be written in numbered ordered opaque envelopes prepared by the statistician. Randomisation will occur within 30-60 minutes prior to extubation. At that point the nurse will open the envelope and prepare either the standard equipment or the HFNP.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/01/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

162

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Prince Charles Hospital Foundation

Address [1]

Rode Rd
Chermside QLD 4032

Country [1]

Australia

Primary sponsor type

Individual

Name

Amanda Corley

Address

Critical Care Research Group
Level 5 Clinical Sciences Building
Rode Rd
Chermside QLD 4032

Country

Australia

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

Critical Care Research Group

Address [1]

Level 2 Adult Intensive Care
Rode Rd
Chermside QLD 4032

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital Human Research and Ethics Committee

Ethics committee address [1]

Rode Rd
Chermside QLD 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/08/2010

Ethics approval number [1]

HREC/10/QPCH/83

Summary

Brief summary

Open heart surgery is being performed on increasing numbers of obese patients. Almost a third of patients undergoing open heart surgery are classified as obese. It is known that these patients are more prone to post operative complications, particularly lung collapse and that they recover more slowly from these complications. This increase in complications and slower recovery leads to longer intensive care unit and hospital stays. Our previous research has shown that high flow nasal prongs (HFNP) create positive airway pressure and that patients who are obese benefit even more from the positive effects of HFNP. Our study also showed that the patients' oxygen levels improved and their breathing felt more comfortable with the HFNP. Therefore, it is necessary that we further investigate the effects of HFNP on obese patients after cardiac surgery, in an attempt to reduce complications, particularly lung collapse.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Amanda Corley

Address

Critical Care Research Group
Level 5 Clinical Sciences Buidling
Rode Rd
Chermside QLD 4032

Country

Australia

Phone

+61 7 3139 5772

Fax

[email protected]

Contact person for scientific queries

Name

Amanda Corley

Address

Critical Care Research Group
Level 5 Clinical Sciences Buidling
Rode Rd
Chermside QLD 4032

Country

Australia

Phone

+61 7 3139 5772

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients	2011	https://doi.org/10.1093/bja/aer265

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically