Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery

NCT05795608 | Completed

• 1 other identifier: RSyaiful
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is the first clinical trial study in Indonesia to assess the benefits of using incentive spirometry in the incidence of pulmonary complications after major abdominal surgery. This study was a randomized clinical trial in three tertiary-level referral hospitals in Indonesia (Cipto Mangunkusumo Hospital, Fatmawati Hospital, and Persahabatan Hospital). The investigators randomly assigned adult patients who underwent major abdominal elective surgery in July-August 2015 to two groups. All study subjects were simple randomly allocated to the intervention and control groups according to the randomization table. The hypothesis of the study team was that preoperative incentive spirometry can improve the incidence of postoperative pulmonary complications in major abdominal surgery

Conditions

Incentive Spirometry; Postoperative Pulmonary Complication; Major Abdominal Surgery

Keywords

Incentive spirometry; major abdominal surgery; pulmonary complication

Outcome Measures

Primary Outcomes (3)

• number of participants with atelectasis

  The loss of lung volume is caused by inadequate expansion of the air spaces lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist

  day 1 until day 7

• number of participants with pneumonia

  Any form of infection of the lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist

  day 1 until day 7

• number of participants with hypoxaemia

  Hypoxaemia was defined as PaO2/FiO2 \<300 as assessed by blood gas analysis

  day 1 until day 7

Secondary Outcomes (3)

• vital capacity

  Preoperative, day 1 before surgery, and until day 7 after surgery

• forced vital capacity

  Preoperative, day 1 before surgery, and until day 7 after surgery

• Forced expiratory volume in the first second

  Preoperative, day 1 before surgery, and until day 7 after surgery

Study Arms (2)

intervention group

EXPERIMENTAL

The intervention group received respiratory exercise with incentive spirometry before surgery

Device: respiratory exercise with incentive spirometry

control group

NO INTERVENTION

The control group were given standard preoperative care.

Interventions

respiratory exercise with incentive spirometry DEVICE

Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, they were asked to inhale deeply and slowly, and they were also directed to hold their breath at the end of inspiration

intervention group

Eligibility Criteria

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

You may qualify if:

• Patients undergoing major abdominal surgery
• aged between 18 and 65 years old
• Sign research informed consent

You may not qualify if:

• Emergency surgery
• Have a history of lung disorders
• Refusing to continue incentive spirometry
• Patients who cannot follow instructions in using the device incentive spirometry.

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Related Publications (21)

• McAlister FA, Bertsch K, Man J, Bradley J, Jacka M. Incidence of and risk factors for pulmonary complications after nonthoracic surgery. Am J Respir Crit Care Med. 2005 Mar 1;171(5):514-7. doi: 10.1164/rccm.200408-1069OC. Epub 2004 Nov 24.

  PMID: 15563632 BACKGROUND

• Hall JC, Tarala RA, Hall JL, Mander J. A multivariate analysis of the risk of pulmonary complications after laparotomy. Chest. 1991 Apr;99(4):923-7. doi: 10.1378/chest.99.4.923.

  PMID: 2009796 BACKGROUND

• Kodra N, Shpata V, Ohri I. Risk Factors for Postoperative Pulmonary Complications after Abdominal Surgery. Open Access Maced J Med Sci. 2016 Jun 15;4(2):259-63. doi: 10.3889/oamjms.2016.059. Epub 2016 May 22.

  PMID: 27335597 BACKGROUND

• Kehrer HE. [Infantile autism and drug therapy]. Bibl Psychiatr. 1978;(157):91-7. No abstract available. German.

  PMID: 348194 BACKGROUND

• Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832.

  PMID: 24155356 BACKGROUND

• Haines KJ, Skinner EH, Berney S; Austin Health POST Study Investigators. Association of postoperative pulmonary complications with delayed mobilisation following major abdominal surgery: an observational cohort study. Physiotherapy. 2013 Jun;99(2):119-25. doi: 10.1016/j.physio.2012.05.013. Epub 2012 Sep 23.

  PMID: 23219632 BACKGROUND

• Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.

  PMID: 12682500 BACKGROUND

• Lyager S, Wernberg M, Rajani N, Boggild-Madsen B, Nielsen L, Nielsen HC, Andersen M, Moller J, Silberschmid M. Can postoperative pulmonary conditions be improved by treatment with the Bartlett-Edwards incentive spirometer after upper abdominal surgery? Acta Anaesthesiol Scand. 1979 Aug;23(4):312-9. doi: 10.1111/j.1399-6576.1979.tb01456.x.

  PMID: 495034 BACKGROUND

• Patel K, Hadian F, Ali A, Broadley G, Evans K, Horder C, Johnstone M, Langlands F, Matthews J, Narayan P, Rallon P, Roberts C, Shah S, Vohra R. Postoperative pulmonary complications following major elective abdominal surgery: a cohort study. Perioper Med (Lond). 2016 May 23;5:10. doi: 10.1186/s13741-016-0037-0. eCollection 2016.

  PMID: 27222707 RESULT

• Yang CK, Teng A, Lee DY, Rose K. Pulmonary complications after major abdominal surgery: National Surgical Quality Improvement Program analysis. J Surg Res. 2015 Oct;198(2):441-9. doi: 10.1016/j.jss.2015.03.028. Epub 2015 Mar 18.

  PMID: 25930169 RESULT

• Kim TH, Lee JS, Lee SW, Oh YM. Pulmonary complications after abdominal surgery in patients with mild-to-moderate chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2016 Nov 9;11:2785-2796. doi: 10.2147/COPD.S119372. eCollection 2016.

  PMID: 27877032 RESULT

• Avila AC, Fenili R. Incidence and risk factors for postoperative pulmonary complications in patients undergoing thoracic and abdominal surgeries. Rev Col Bras Cir. 2017 May-Jun;44(3):284-292. doi: 10.1590/0100-69912017003011. English, Portuguese.

  PMID: 28767805 RESULT

• Carvalho CR, Paisani DM, Lunardi AC. Incentive spirometry in major surgeries: a systematic review. Rev Bras Fisioter. 2011 Sep-Oct;15(5):343-50. doi: 10.1590/s1413-35552011005000025. Epub 2011 Oct 14.

  PMID: 22002191 RESULT

• Thomas JA, McIntosh JM. Are incentive spirometry, intermittent positive pressure breathing, and deep breathing exercises effective in the prevention of postoperative pulmonary complications after upper abdominal surgery? A systematic overview and meta-analysis. Phys Ther. 1994 Jan;74(1):3-10; discussion 10-6. doi: 10.1093/ptj/74.1.3.

  PMID: 8265725 RESULT

• Tyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.

  PMID: 25607594 RESULT

• Ramirez-Sarmiento A, Orozco-Levi M, Guell R, Barreiro E, Hernandez N, Mota S, Sangenis M, Broquetas JM, Casan P, Gea J. Inspiratory muscle training in patients with chronic obstructive pulmonary disease: structural adaptation and physiologic outcomes. Am J Respir Crit Care Med. 2002 Dec 1;166(11):1491-7. doi: 10.1164/rccm.200202-075OC. Epub 2002 Jul 19.

  PMID: 12406842 RESULT

• Kulkarni SR, Fletcher E, McConnell AK, Poskitt KR, Whyman MR. Pre-operative inspiratory muscle training preserves postoperative inspiratory muscle strength following major abdominal surgery - a randomised pilot study. Ann R Coll Surg Engl. 2010 Nov;92(8):700-7. doi: 10.1308/003588410X12771863936648. Epub 2010 Jul 26.

  PMID: 20663275 RESULT

• Toor H, Kashyap S, Yau A, Simoni M, Farr S, Savla P, Kounang R, Miulli DE. Efficacy of Incentive Spirometer in Increasing Maximum Inspiratory Volume in an Out-Patient Setting. Cureus. 2021 Oct 4;13(10):e18483. doi: 10.7759/cureus.18483. eCollection 2021 Oct.

  PMID: 34754645 RESULT

• Kotani T, Akazawa T, Sakuma T, Nagaya S, Sonoda M, Tanaka Y, Katogi T, Nemoto T, Minami S. Effects of Incentive Spirometry on Respiratory Motion in Healthy Subjects Using Cine Breathing Magnetic Resonance Imaging. Ann Rehabil Med. 2015 Jun;39(3):360-5. doi: 10.5535/arm.2015.39.3.360. Epub 2015 Jun 30.

  PMID: 26161341 RESULT

• Kulnik ST, Rafferty GF, Birring SS, Moxham J, Kalra L. A pilot study of respiratory muscle training to improve cough effectiveness and reduce the incidence of pneumonia in acute stroke: study protocol for a randomized controlled trial. Trials. 2014 Apr 12;15:123. doi: 10.1186/1745-6215-15-123.

  PMID: 24725276 RESULT

• do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.

  PMID: 24510642 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Digestive Surgery

Model Details: Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, they were asked to inhale deeply and slowly, and they were also directed to hold their breath at the end of inspiration.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: July 1, 2015
• Primary Completion: August 10, 2015
• Study Completion: September 1, 2015
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share