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

NCT06341244 | Completed DMC

• 1 other identifier: UNIFESP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Care

Keywords

Physiotherapy; Cough; Peak Expiratory Flow

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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

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

Secondary Outcomes (2)

• Maximum Inspiratory Pressure ( MIP)

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

• Maximun Expiratory Pressure (MEP)

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

Study Arms (1)

Air staking technique group

EXPERIMENTAL

The air staking group

Device: Air Stacking Technique

Interventions

Air Stacking Technique DEVICE

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.

Air staking technique group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Luciana Chiavegato

São Paulo, 04115000, Brazil

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciana D Chiavegato, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 2, 2024
• Study Start: August 20, 2019
• Primary Completion: November 5, 2020
• Study Completion: December 15, 2022
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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

Locations

BR (1)