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Completed

NCT Number: NCT01993602

Lung Expansion Technics on Chest Wall Mechanics and Preventing Pulmonary Complication After Abdominal Surgery

The lung expansion techniques are widely used to prevent postoperative pulmonary complications. However, the effect of each technique on thoracoabdominal mechanics after abdominal surgery and if it influences the rate of postoperative pulmonary complications remains unknown. The investigators hypothesis is that the lung expansion technique that more increases lung volume after abdominal surgery, will be the most efficient in preventing postoperative pulmonary complication after abdominal surgery. The investigators objectives will be to compare the effect of different lung expansion techniques on lung volumes and activation of inspiratory muscle, and prevention of pulmonary complications in patients undergoing upper abdominal surgery. This study will involve 171 patients undergoing elective abdominal surgery. Patients will be randomly divided into 5 groups: no therapy group (n=35), continuous positive airway pressure (CPAP, n=34); volumetric incentive spirometry (VIS, n=34); flow oriented incentive spirometry (FIS, n=33) and deep breathing (DB, n=35). The thoracoabdominal mechanics will be assessed before and 3 days after surgery. Complications will be evaluated by a researcher who did not know to which group each patient belongs.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Clinics of School of Medicine of University of Sao Paulo

São Paulo, 05403-010, Brazil

About this study

The assessments performed were thoracoabdominal kinematics (by optoelectronic pletysmography)and respiratory muscles activity (by surface electromyography). The follow pulmonary complications were considered: pneumonia, tracheobronchitis, atelectasis and acute respiratory failed

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • candidates for elective upper abdominal surgery expected to last longer than 120 minutes
  • absent of spine or thoracic deformity
  • no previous lung parenchyma resection
  • no tracheostomy
  • able to understand and perform the maneuvers proposed.

Exclusion criteria

  • cancellation of surgery
  • mechanical ventilation for more than 24 hours in the postoperative period
  • need for chest tube use
  • postoperative cardiac complications
  • surgical complication
  • reoperation

Treatment and study plan

Breathing exercises

Procedure

The intervention groups (CPAP, VIS, FIS and DB) used the specific device (or not) according to the group allocation.

The intervention was performed 3 times per day, from 1 to 5 postoperative day. Patients performed 5 sets of 10 repetitions of the specific breathing exercise, with 30 seconds rest between each set.

The sessions were held in the morning, early afternoon and early evening, always supervised by a physiotherapist.

Before starting each session, the patient reported the sensation of pain, and if he quantify pain intensity more than 3 in the visual numeric scale (0 to 10) was asked the doctor to administer analgesics aiming that him to perform properly the breathing exercise.

Primary outcomes

  1. thoracoabdominal volume

    Time frame: third postoperative day

    thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)

Secondary outcomes

  1. postoperative pulmonary complication

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

    evaluation of pulmonary complications was performed according to pre-established criteria in the research project

Other outcomes

  1. activity inspiratory muscles

    Time frame: third postoperative day

    evaluation was performed by surface electromyography

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

COMPARISON OF LUNG EXPANSION TECHNICS ON THORACOABDOMINAL MECHANICS AND THEIR INFLUENCE ON THE INCIDENCE OF PULMONARY COMPLICATIONS AFTER ABDOMINAL SURGERY: A RANDOMIZED AND CONTROLLED CLINICAL TRIAL

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 25, 2013
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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