Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000975594p
Ethics application status
Not yet submitted
Date submitted
14/06/2024
Date registered
12/08/2024
Date last updated
12/08/2024
Date data sharing statement initially provided
12/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring lung aeration change with lung ultrasound in response to physiotherapy breathing techniques
Scientific title
INhalation PHysiOtherapy interventions to Change lung Ultrasound Scores in adults undergoing abdominal surgery
Secondary ID [1] 312340 0
Nil
Universal Trial Number (UTN)
Trial acronym
INPHOCUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pulmonary complications 334109 0
postoperative atelectasis 334110 0
Condition category
Condition code
Respiratory 330782 330782 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 330994 330994 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TIDieR Criterion

Intervention 1
Name: Incentive spirometry (IS)
Rationale: Facilitates a patient to perform a slow sustained inspiration, producing a sustained maximal inspiration to aid the re-expansion of collapsed alveoli in the setting of atelectasis. When breathing in through an incentive spirometer, a piston rises inside the device and measures the volume of the inspired air. It encourages the patient to perform a slow and deep inspiration through visual feedback.46
Goal: The patient is verbally informed of their risk of postoperative pulmonary complications following surgery and the benefit that IS can have on increasing lung volumes, improving gas exchange, assisting secretion removal and preventing postoperative atelectasis and other complications. A single page handout will also reinforce verbal information, and provide step-by-step instructions on how to complete IS.
Materials: A single page handout will be given to participants to reinforce verbal education about PPC risk and the role of IS in reducing this risk.
Intervention providers: Familiarisation with protocol prior to treating participants.
The IS device used will be the Voldyne 4000 Volumetric Exerciser from Medline.
Procedure: The IS exercises will be taught to and performed by the participant in a single physiotherapy session. The participant will be positioned in a semi-recumbent position in bed. IS exercises will consist of 4 sets of 5 slow breaths to maximal inspiratory capacity, as instructed below:
(1) hold the device in front of your mouth with relaxed elbows; (2) breathe out; (3) place lips around mouthpiece and seal; (4) inhale slowly and deeply through the mouth and see how high you can raise the yellow float here; (5) once you have reached your capacity to breathe in, hold the breath for 3-5 seconds; (6) take the mouthpiece out of your mouth and breathe out slowly. Each set of 5 breaths are followed by three coughs, or a forced expiratory technique with an open glottis called a “huff”, with a small firm pillow pressed over the abdominal incision to support the wound and to encourage greater expiratory force. It is at the treating physiotherapist’s discretion to place hands on the patient’s chest wall during the coaching sessions to provide tactile feedback of performance.
Who: Research or clinical physiotherapists will deliver the intervention
How: Face-to-face, a single physiotherapy session with an individual participant
Where: The study will take place in the inpatient hospital setting, in the intensive care unit/HDU or surgical step down unit of three participating government funded public hospitals. The hospital delivering IS will be a 357-bed tertiary referral hospital in northern Tasmania, with a 13-bed Level III general ICU.

Intervention 2
Name: Bubble positive expiratory pressure (PEP)
Rationale: A slow, sustained expiration into a water filled chamber produces positive pressure to splint open collapsed alveoli, with the oscillation of water in the chamber producing vibration in the airways to help shear secretions for expectoration.
Goal: The patient is verbally informed of their risk of postoperative pulmonary complications following surgery and the benefit that bubble PEP can have on promoting secretion clearance, increasing lung volumes, improving gas exchange and preventing postoperative atelectasis and other complications. A single page handout will also reinforce verbal information, and provide step-by-step instructions on how to complete bubble PEP.
Materials: A single page handout will be given to participants to reinforce verbal education about PPC risk and the role of bubble PEP in reducing this risk.
Intervention providers: Familiarisation with protocol prior to treating participants.
The bubble PEP device consists of a bottle of water for irrigation measuring 21cm in height and 10cm in width. The bottle will be filled with 10cm of water, to ensure positive expiratory pressure generated by the device remains between 11-13cmH20. The suction tubing used will have an internal diameter of 1cm, and a length of 30cm. The bottom of the suction tubing will rest on the bottom of the bottle. The bottle will be filled with water to a height of 10cm.47
Procedure: Bubble PEP will be taught to and performed by the participant in a single physiotherapy session. The participant will be positioned in a semi-recumbent position in bed. Bubble PEP exercises will consist of 5 slow sustained expirations in to a chamber of water as instructed below.
(1) hold the bottle in front of your mouth with relaxed elbows; (2) inhale slowly, slightly deeper than a normal breath; (3) place lips around the tubing and seal; (4) exhale slowly through your mouth for 3-5 seconds, you should see steady bubbling in the water bottle; (5) take the mouthpiece out of your mouth and inhale slowly, slightly deeper than normal.

Each set of 5 breaths are followed by three coughs, or a forced expiratory technique with an open glottis called a “huff”, with a small firm pillow pressed over the abdominal incision to support the wound and to encourage greater expiratory force. It is at the treating physiotherapist’s discretion to place hands on the patient’s chest wall during the coaching sessions to provide tactile feedback of performance.

Who: Research or clinical physiotherapists will deliver the intervention
How: Face-to-face, a single physiotherapy session with an individual participant
Where: The study will take place in the inpatient hospital setting, in the intensive care unit/HDU or surgical step down unit of three participating government funded public hospitals. The hospital delivering bubble PEP will be a 600-bed tertiary referral hospital in Northern Sydney Australia, with a 58-bed Level III general (including major trauma, burns, spinal cord injuries), cardiothoracic and neurosurgical ICU.

Participants will receive only one of the three listed treatments above as part of their participation in the study. Each study site will be delivering one type of technique. RNSH will deliver bubble PEP, Royal Perth Hospital will deliver deep breathing exercises and Launceston General Hospital will deliver incentive spirometry. Participants will still also receive respiratory physiotherapy treatment techniques as part of standard care regardless of their involvement in the study.
Intervention code [1] 328827 0
Treatment: Other
Comparator / control treatment
Name: Deep breathing exercises (DBE)
Rationale: A slow, sustained inspiration with an end inspiratory hold promotes re-expansion of collapsed alveoli through increased lung volumes and collateral channel ventilation.
Goal: The patient is verbally informed of their risk of postoperative pulmonary complications following surgery and the benefit that DBE can have on increasing lung volumes, improving gas exchange, assisting secretion removal and preventing postoperative atelectasis and other complications. A single page handout will also reinforce verbal information, and provide step-by-step instructions on how to complete DBE.
Materials: A single page handout will be given to participants to reinforce verbal education about PPC risk and the role of DBE in reducing this risk.
Intervention providers: Familiarisation with protocol prior to treating participants.
Procedure: DBE will be taught to and performed by the participant in a single physiotherapy session. The participant will be positioned in a semi-recumbent position in bed. DBE will consist of four sets of 5 slow breaths to maximal capacity, as instructed below.
(1) inhale slowly and deeply until you reach your capacity to breathe in
(2) take 2-3 sniff breaths in through your nose
(3) hold your breath for 3-5 seconds
(4) breath out through your mouth slowly

Each set of 5 breaths are followed by three coughs, or a forced expiratory technique with an open glottis called a “huff”, with a small firm pillow pressed over the abdominal incision to support the wound and to encourage greater expiratory force. It is at the treating physiotherapist’s discretion to place hands on the patient’s chest wall during the coaching sessions to provide tactile feedback of performance.
Who: Research or clinical physiotherapists will deliver the intervention
How: Face-to-face, a single physiotherapy session with an individual participant
Where: The study will take place in the inpatient hospital setting, in the intensive care unit/HDU or surgical step-down unit of three participating government funded public hospitals. The hospital delivering DBE will be a 450-bed tertiary referral hospital in Western Australia, with a 24-bed Level III general and trauma ICU/HDU and a 9-bed HIVE (Health in virtual environment) monitored surgical step-down unit.
Control group
Active

Outcomes
Primary outcome [1] 338542 0
Change in lung ultrasound score immediately following a respiratory physiotherapy treatment compared to pre- treatment
Timepoint [1] 338542 0
Lung ultrasound will be performed prior to and following delivery of respiratory physiotherapy treatment techniques on postoperative day 1. Lung ultrasound will also be performed on postoperative day 2
Secondary outcome [1] 436376 0
Incidence of postoperative pulmonary complications, for example atelectasis, pneumonia, hypoxemia.
Timepoint [1] 436376 0
Melbourne Group Score collected on postoperative days 1, 2 and 3
Secondary outcome [2] 436379 0
hospital-acquired pneumonia
Timepoint [2] 436379 0
Collected on postoperative days 1, 2 and 3
Secondary outcome [3] 436380 0
escalation of medical therapy for respiratory deterioration
Timepoint [3] 436380 0
Collected on postoperative days 1, 2 and 3
Secondary outcome [4] 436381 0
intensive care unit length of stay
Timepoint [4] 436381 0
Collected at time of patient discharge from hospital
Secondary outcome [5] 436382 0
hospital length of stay
Timepoint [5] 436382 0
Collected at time of patient discharge from hospital

Eligibility
Key inclusion criteria
Adults (>18yrs) having elective or emergency open upper abdominal surgery and/or hand-assisted laparoscopic abdominal surgery with an abdominal incision longer than 5cm that is above or extending above the umbilicus, who are spontaneously ventilating, and are in the intensive care unit, high dependency unit or surgical step-down unit on their first postoperative day
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to understand written or spoken English and unable to provide consent to participate in the study.

Patients who remain intubated and ventilated or receive non-invasive positive pressure ventilation on the first postoperative day, or are extubated after midnight on postoperative day 0

Bulky dressings that impede ultrasound imaging of the chest wall.

Body habitus preventing optimal ultrasound imaging.

A LUS clinician is unavailable.

Patients who have undergone an Ivor-Lewis esophagectomy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using SPSS software. Descriptive statistics will be reported as mean, median or n (%). The comparison of the pre and post respiratory physiotherapy treatment LUS score to quantify changes in lung aeration will be analysed using a paired t-test or Wilcoxin sign-rank test depending on distribution of data. Correlation coefficient will be used to determine the association between the LUS score and secondary outcome measures. Lung ultrasound aeration score performance to predict a PPC will be assessed using the area under the receiver operating characteristic curve (AUROCC) and prognostic accuracy summary statistics (sensitivity, specificity, positive predictive value, and negative predictive value). A cutoff score will be estimated where the highest sensitivity and specificity is returned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
63
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS,WA
Recruitment hospital [1] 26677 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 26678 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 26679 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 42718 0
2065 - St Leonards
Recruitment postcode(s) [2] 42719 0
6000 - Perth
Recruitment postcode(s) [3] 42720 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 316737 0
Government body
Name [1] 316737 0
National Health and Medical Research Council
Country [1] 316737 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District, NSW Health
Address
Country
Australia
Secondary sponsor category [1] 318955 0
None
Name [1] 318955 0
Address [1] 318955 0
Country [1] 318955 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315511 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315511 0
Ethics committee country [1] 315511 0
Australia
Date submitted for ethics approval [1] 315511 0
15/09/2024
Approval date [1] 315511 0
Ethics approval number [1] 315511 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134930 0
Dr Louise Hansell
Address 134930 0
Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 134930 0
Australia
Phone 134930 0
+61 432882934
Fax 134930 0
Email 134930 0
[email protected]
Contact person for public queries
Name 134931 0
Louise Hansell
Address 134931 0
Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 134931 0
Australia
Phone 134931 0
+61 432882934
Fax 134931 0
Email 134931 0
[email protected]
Contact person for scientific queries
Name 134932 0
Louise Hansell
Address 134932 0
Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 134932 0
Australia
Phone 134932 0
+61 432882934
Fax 134932 0
Email 134932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.