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CompletedNCT06341244Updated Apr 2, 2024

Air Stacking Technique Efficacy on Peak of Expiratory Flow and Cough Peak Flow in Non-cardiac Thoracic Surgery

An interventional study of Air Stacking Technique in Postoperative Care, sponsored by Universidade Cidade de Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by Universidade Cidade de Sao Paulo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 6 months after the study started (first participant enrolled Aug 2019, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

After thoracic surgical intervention, patients often feel intense pain with respiratory movements reduction making coughing less effective. The air stacking improves peak of expiratory flow (PEF) and cough peak flow (CPF) in neuro myopathies, thus raising the hypothesis that may also be effective in patients undergoing thoracic surgeries. Objectives: To evaluate the effectiveness, safety and feasibility of air stacking on postoperative PEF and CPF in patients undergoing thoracic surgeries. Methods: Patients undergoing thoracic surgery underwent air stacking on 3th PO. Dyspnea, pain, SpO2, maximum inspirational pressure (MIP), maximum expiratory pressure (MEP), PEF and CPF were evaluated in pre and postoperatory.

Read the detailed description

Surgical intervention is a treatment option for many diseases of the thorax . After thoracotomy, ventilatory patterns change, lung volumes and pulmonary capacities decrease due to the reflex inhibition of the diaphragm muscle, and the sigh mechanism becomes impaired, even if the procedure does not include pulmonary resection . These changes often lead to postoperative pulmonary complications, which may increase length of stay in the hospital. The role of physical therapy in minimizing these risks is critical, and several techniques are available to improve both lung volume and capacity and to make coughing more effective. The air stacking technique allows enough air to be accumulated in the lungs to generate an acceptable cough peak flow (CPF). Several studies have shown that the use of this technique in patients with neuromuscular disease positively impacts the biomechanical components of peak expiratory flow (PEF) and CPF. This study aimed to evaluate the effectiveness, safety and feasibility of the air stacking technique application and its effect on PEF and CPF during the postoperative period in patients undergoing elective noncardiac intrathoracic surgery We conducted an interventional experimental study involving hospitalized patients for thoracic surgery in a teaching hospital. The study was approved by the Ethics Committee in Human Research (42693015.0.000.5505), and the patients freely signed an informed consent form prior to participation. Maximal inspiratory and expiratory pressure (MIP and MEP) were measured with a previously calibrated aneroid manometer (GER-AR®), ranging from 5 to ± 300 cmH2O. A mouthpiece was attached to the manovacuometer, and the nasal clip was used during the maneuvers following previous recommendations. (12) For maximal inspiratory and expiratory pressures assessment, maximum effort was requested from the residual volume and total lung capacity, respectively. Results were compared to predicted values according to the equation proposed by Neder et al. PEF and CPF were measured with a peak flow meter ranging from 100 to 900 L/min following the literature recommendations. The patient remained seated at 90º with a nasal clip and was asked to force maximum expiration as fast as he could through the mouthpiece after maximum inspiration to measure PEF. To measure cough peak flow, the patient repeated the inspiratory maneuver and was asked to cough as hard as he could. At least three measurements of both variables were performed, provided that the last measurement was not higher than others. The highest obtained value was considered as the result. To perform the air stacking technique, an air manual breathing unit (AMBU) was used, attached to a unidirectional valve and nasal/oral mask. The technique was performed with the patient in a sitting position, head resting on a smooth surface to avoid neck hyperextension. The mask was fit to the patient's face, and the AMBU one-way valve was kept closed. For each AMBU manual compression (three in the total), the patient was instructed to breathe in deeply and hold the air inside the lungs. Immediately after the first manual compression, the second and third were performed while the patient is deep breathing in together, without exhaling the air. PEF was measured immediately after the technique. The patient rested for 5 minutes, and the air staking technique was repeated. The same procedure was performed to measure CPF followed by a clinical evaluation including vital signs, visual lung expansion and auscultation, dyspnea, and pain evaluation. Sample size calculation was based on previous study performed by Brito et al. A minimum difference of 4% and a maximum difference of 47% were found between PEF and CPF means before and after air stacking technique. Considering a power of 90% and an alpha error of 5%, a power analysis revealed that a minimum number of 17 patients should be included in the study.

02

Conditions studied

  • Postoperative Care

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Keywords

  • Physiotherapy
  • Cough
  • Peak Expiratory Flow
03

In context

Cough

427 studies on the registry are indexed under Cough; 67 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 319 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Universidade Cidade de Sao Paulo is the lead sponsor of 42 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 years or older eligible for elective noncardiac intrathoracic surgery;
  • Any gender;
  • Clinically stable
  • Able to perform study procedures.

Exclusion criteria

Exclusion Criteria:

  • Patients remained on mechanical ventilation for more than 72 hours at the PO;
  • Rib fracture
  • Rehospitalization in the ICU or readmission to the intensive care unit (ICU);
  • Lowed level of consciousness, nausea and vomiting;
  • Hemodynamic instability;
  • New surgical intervention before the 3rd.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Air staking technique group

    The air staking group

    Device: Air Stacking Technique

Interventions

  • DeviceAir Stacking Technique

    To perform the air stacking technique, an air manual breathing unit (AMBU) was used, attached to a unidirectional valve and nasal/oral mask. For each AMBU manual compression (three in the total), the patient was instructed to breathe in deeply and hold the air inside the lungs.

06

What researchers measure

Primary outcomes

  1. Peak of expiratory flow (PEF)

    PEF was measured with a peak flow meter ranging from 100 to 900 L/min (Philips Respironics®) following the literature recommendations. The patient remained seated at 90º with a nasal clip and was asked to force maximum expiration as fast as he could through the mouthpiece after maximum inspiration to measure PEF

    Time frame: pre operative and 3th postoperative day ( pre and pos air stacking application)

  2. Cough peak flow (CPF)

    CPF were measured with a peak flow meter ranging from 100 to 900 L/min (Philips Respironics®) following the literature recommendations. The patient remained seated at 90º with a nasal clip and was asked to force maximum expiration as fast as he could through the mouthpiece after maximum inspiration to measure PEF. To measure cough peak flow, the patient repeated the inspiratory maneuver and was asked to cough as hard as he could. At least three measurements of both variables were performed

    Time frame: pre operative and 3th postoperative day ( pre and pos air stacking application)

Secondary outcomes

  1. Maximum Inspiratory Pressure ( MIP)

    MIP and MEP) were measured with a previously calibrated aneroid manovacuometer (GER-AR®), ranging from 5 to ± 300 cmH2O. A mouthpiece was attached to the manovacuometer, and the nasal clip was used during the maneuvers following previous recommendations

    Time frame: pre operative and 3th postoperative day ( pre and pos air stacking application)

  2. Maximun Expiratory Pressure (MEP)

    MIP and MEP) were measured with a previously calibrated aneroid manovacuometer (GER-AR®), ranging from 5 to ± 300 cmH2O. A mouthpiece was attached to the manovacuometer, and the nasal clip was used during the maneuvers following previous recommendations

    Time frame: pre operative and 3th postoperative day ( pre and pos air stacking application)

07

Study locations

1 site
  • Luciana Chiavegato
    São Paulo, 04115000, Brazil
08

References and documents

Individual participant data

Plan to share: Yes — The pre operative evaluation records are available in a box kept in the private hospital specific room.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: The data been available since the beginning and will be until the study publication

Access criteria: All researchers involved will have access to the hospital private room and data

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2019 to primary completion in Nov 2020, 14 months.

Of 78 non-industry interventional studies with no phase under Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 14 months is close to that.

Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 6 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2024
First posted
Apr 2, 2024
StartActual
Aug 20, 2019
Primary completionActual
Nov 5, 2020
CompletionActual
Dec 15, 2022
Last update
Apr 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06341244
Lead sponsor
Universidade Cidade de Sao Paulo
Responsible party
Luciana Chiavegato (PhD, Universidade Cidade de Sao Paulo) — Principal investigator
First posted
Apr 2, 2024
Start date
Aug 20, 2019
Primary completion
Nov 5, 2020
Completion
Dec 15, 2022
Last update
Apr 2, 2024

Study contacts

Luciana D Chiavegato, PhD
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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