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Measuring lung aeration change with lung ultrasound in response to physiotherapy breathing techniques

INhalation PHysiOtherapy interventions to Change lung Ultrasound Scores in adults undergoing abdominal surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000975594
Acronym
INPHOCUS
Enrollment
63
Registered
2024-08-12
Start date
2024-10-01
Completion date
2025-06-30
Last updated
2024-08-19

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

Conditions

None listed

Brief summary

The main aim of this study is to assess the ability of lung ultrasound to detect an immediate change in lung aeration in patients performing physiotherapist- prescribed lung expansion techniques after upper abdominal surgery. This study will also explore if there are differences between three different lung expansion techniques in improving lung aeration score as assessed using lung ultrasound and will assess the agreement between lung ultrasound and postoperative pulmonary complications as diagnosed using the Melbourne Group Score (MGS) in postoperative upper abdominal surgery patients. A multicentre study will be conducted. Participants will have their lung aeration assessed and scored on postoperative day 1 using bedside lung ultrasound. Those for whom loss of lung aeration is identified will then immediately receive a single physiotherapy treatment session of protocolised coached lung expansion techniques commonly used in clinical practice. The participant will receive either positive expiratory pressure bubble therapy, incentive spirometry or deep breathing exercises dependent on the site the participant is being cared at. Immediately following the lung expansion therapy session, a repeat lung ultrasound will be performed. All lung ultrasound scans, both pre and post- therapy, will be scored for lung aeration by an independent skilled assessor who is unaware of the timing of lung ultrasound (either pre or post) and the specific therapy provided. Participants who don't have reduced lung aeration on their first lung ultrasound will receive standard physiotherapy care at the discretion of the ward physiotherapist. All participants will have another lung ultrasound on postoperative day 2, and screened daily for the presence of a postoperative pulmonary complication using the Melbourne Group Score on postoperative days 1, 2 and 3.

Interventions

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 v

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.

Sponsors

Northern Sydney Local Health District, NSW Health
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

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

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026