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Completed

NCT Number: NCT01004146

Pre-op Use of Incentive Spirometry in Obese Patients

The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as an aid to improve postoperative lung function. The hypothesis is that application of a standardized protocol of preoperative respiratory care teaching and exercise will improve lung performance that will subsequently result in prevention of postoperative pulmonary complications and that increasing the duration of preoperative use better improves lung mechanics postoperatively. The investigators propose to compare a patient population that uses IS as currently prescribed in the routine course of care (only to be familiar with preoperatively, but use postoperatively) against a population that uses IS with a standardized regimen for at least 3 days prior to the operation in terms of preoperative IS volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of postoperative pulmonary complications.

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Key information

Conditions

Lung Function Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • morbid obesity
  • bariatric surgery
  • must be able to use incentive spirometer

Exclusion criteria

  • BMI=<40 kg/m2
  • current symptoms of obstructive sleep apnea or actively using continuous positive airway pressure

Treatment and study plan

Incentive spirometry

Procedure

helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse

Primary outcomes

  1. Post Operative Incentive Spirometry Volume

    Time frame: 1 week before surgery to the day after

    After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery.

Secondary outcomes

  1. Level of Compliance

    Time frame: 3 days to 2 weeks after clinic visit on the day of surgery

  2. Oxygen Saturation

    Time frame: one week prior to surgery up to one day after

  3. Heart Rate

    Time frame: one week prior to surgery to post operative day 1

  4. Respiratory Rate

    Time frame: one week prior to surgery to post operative day 1

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

A Study on the Preoperative Use of Incentive Spirometry in Morbidly Obese Patients Undergoing General Anesthesia

Acronym: IS

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Oct 29, 2009
Registry last updated
Feb 3, 2014

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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