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

NCT01993602 | Completed

• 2 other identifiers: 0150/11FAPESP
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Procedure, Unspecified

Keywords

general surgery; postoperative care; breathing exercises; respiratory muscle; postoperative complications; lung volume measurements; pulmonary ventilations; thoracic wall

Outcome Measures

Primary Outcomes (1)

• thoracoabdominal volume

  thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)

  third postoperative day

Secondary Outcomes (1)

• postoperative pulmonary complication

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

Other Outcomes (1)

• activity inspiratory muscles

  third postoperative day

Study Arms (5)

Control group

NO INTERVENTION

no intervention was performed in this group during postoperative period,

volumetric incentive spirometry

ACTIVE COMPARATOR

patients performed breathing exercises using volumetric incentive spirometer during five postoperative days

Procedure: Breathing exercises

Flow oriented incentive spirometry

ACTIVE COMPARATOR

patients performed breathing exercises using flow oriented incentive spirometer during five postoperative days

Procedure: Breathing exercises

Deep breathing group

ACTIVE COMPARATOR

patients performed deep breathing exercises without any device during five postoperative days

Procedure: Breathing exercises

Continuous positive airway pressure group

ACTIVE COMPARATOR

patients performed breathing exercises using continuous positive airway pressure group during five postoperative days

Procedure: Breathing exercises

Interventions

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.

Continuous positive airway pressure group; Deep breathing group; Flow oriented incentive spirometry; volumetric incentive spirometry

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (1)

• Lunardi AC, Paisani DM, Silva CCBMD, Cano DP, Tanaka C, Carvalho CRF. Comparison of lung expansion techniques on thoracoabdominal mechanics and incidence of pulmonary complications after upper abdominal surgery: a randomized and controlled trial. Chest. 2015 Oct;148(4):1003-1010. doi: 10.1378/chest.14-2696.

  PMID: 25973670 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Celso R Carvalho, PhD

  School of Medicine of University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 8, 2016

Record last verified: 2013-11

Locations

BR (1)