Effects of Early Oral Diet After Cardiac Surgery: an Open Label Randomized Controlled Trial

NCT06146426 | Unknown

• 1 other identifier: MRC-01-23-507
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label randomized controlled trial with two parallel groups to compare the effects of early initiation of oral diet to reduce the post-operative fasting time in adult patients undergoing cardiac surgery.Primary Objectives:

• To assess the impact of early and conventional diet on post-operative nausea and vomiting by calculating the simplified PONV (post-operative nausea and vomiting) impact score of patients after cardiac surgery, with a score \>5 indicating clinically significant PONV.
• To study the impact of early versus conventional diet on gastrointestinal function by estimating the difference in timing of the first bowel movement in patients following cardiac surgery. Secondary Objectives:
• To evaluate the effects of early versus conventional diet resumption on length of ICU stay among the patients following cardiac surgery in days.
• To compare the satisfaction levels of patients by visual analogue scale who resumed their oral diets early versus conventionally following cardiac surgery. The estimated sample size of 196 patients with routine post operative recovery after cardiac surgery will be randomized into early (interventional) and late (control) diet groups. Researchers will compare the early diet group with late diet group to see the effects.

Conditions

Adult Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• simplified post operative nausea vomiting impact score.

  To assess the impact of early and conventional diet on post-operative nausea and vomiting by calculating the simplified PONV (post-operative nausea and vomiting) impact score of patients after cardiac surgery, with a score \>5 indicating clinically significant PONV.

  24 hours

• Timing of bowel movements

  To study the impact of early versus conventional diet on gastrointestinal function by estimating the difference in timing of the first bowel movement in patients of both groups following cardiac surgery.

  5 days

Secondary Outcomes (2)

• length of ICU stays in days.

  5 days

• patient satisfaction

  2 days

Study Arms (2)

Early diet

EXPERIMENTAL

The patients of early group will be performed water swallowing test at bedside after 2 hours of extubation. Before performing the Water Swallow Test, the patient must be evaluated for readiness.This interventional group of patients will be initiated with sips of water (warm or cold as patient prefers) at 2 hours of extubation (post-operative day 0) followed by clear liquid diet (tea, clear juice/ soup, gelatin) at 4 hours. If well tolerated, then slowly progress to a full liquid and solid diet as the patient preferred pace.

Dietary Supplement: Early diet resumption

Conventional diet

NO INTERVENTION

Patients in this group will receive the existing standard (conventional) post-operative diet regimen that is sips of water on the day of surgery and initiation of solid oral diet on next day (post-operative day 1)

Interventions

Early diet resumption DIETARY_SUPPLEMENT

Resuming oral diet at pace started from 2 hours after extubation from ventilator.

Early diet

Eligibility Criteria

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

You may qualify if:

• Patients' post-operative status,
• Post extubation (usually extubated within 4-6 hours after surgery) without any cognitive deficits, expected
• Minimal chest drain (\<100 ml/h), with
• Awake, alert, oriented without any cognitive impairment
• Able to pass water swallow test will be included in the study.

You may not qualify if:

• Major complicated cardiac surgeries (aortic dissection, surgeries involving mechanical circulatory support (ECMO or Ventricular assist devices).
• Patients with profuse surgical /chest drain bleeding \>100 ml/h for 3 consecutive hours in chest drain,
• Patients undergo re-exploration sternotomy, cardiac tamponade and
• Patients with cognitive impairment, drowsy
• Absence of vocalization after extubation
• Patients who fails in water swallow test for dysphagia after extubation

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Heart Hospital

Doha, 3050, Qatar

RECRUITING

Related Publications (19)

• Bowling TE. Does disorder of gastrointestinal motility affect food intake in the post-surgical patient? Proc Nutr Soc. 1994 Mar;53(1):151-7. doi: 10.1079/pns19940018.

  PMID: 8029224 BACKGROUND

• Brown JK, Singh K, Dumitru R, Chan E, Kim MP. The Benefits of Enhanced Recovery After Surgery Programs and Their Application in Cardiothoracic Surgery. Methodist Debakey Cardiovasc J. 2018 Apr-Jun;14(2):77-88. doi: 10.14797/mdcj-14-2-77.

  PMID: 29977464 BACKGROUND

• Charoenkwan K, Phillipson G, Vutyavanich T. Early versus delayed (traditional) oral fluids and food for reducing complications after major abdominal gynaecologic surgery. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD004508. doi: 10.1002/14651858.CD004508.pub3.

  PMID: 17943817 BACKGROUND

• Feng S, Chen L, Wang G, Chen A, Qiu Y. Early oral intake after intra-abdominal gynecological oncology surgery. Cancer Nurs. 2008 May-Jun;31(3):209-13. doi: 10.1097/01.NCC.0000305729.57722.a7.

  PMID: 18453877 BACKGROUND

• Hill A, Nesterova E, Lomivorotov V, Efremov S, Goetzenich A, Benstoem C, Zamyatin M, Chourdakis M, Heyland D, Stoppe C. Current Evidence about Nutrition Support in Cardiac Surgery Patients-What Do We Know? Nutrients. 2018 May 11;10(5):597. doi: 10.3390/nu10050597.

  PMID: 29751629 BACKGROUND

• Jejurikar SS, Orseck MJ, Matarasso A. Reevaluating resumption of oral intake after abdominoplasty. Aesthet Surg J. 2007 May-Jun;27(3):233-8. doi: 10.1016/j.asj.2007.03.004.

  PMID: 19341649 BACKGROUND

• Kolodziej T, Maciejewski T, Mendrala K, Darocha T, Weglarzy A, Budziarz B, Kiermasz K, Kucewicz-Czech EM. Enhanced recovery after cardiac surgery. Kardiochir Torakochirurgia Pol. 2019 Mar;16(1):32-36. doi: 10.5114/kitp.2019.83943. Epub 2019 Apr 4.

  PMID: 31043973 BACKGROUND

• Minig L, Biffi R, Zanagnolo V, Attanasio A, Beltrami C, Bocciolone L, Botteri E, Colombo N, Iodice S, Landoni F, Peiretti M, Roviglione G, Maggioni A. Reduction of postoperative complication rate with the use of early oral feeding in gynecologic oncologic patients undergoing a major surgery: a randomized controlled trial. Ann Surg Oncol. 2009 Nov;16(11):3101-10. doi: 10.1245/s10434-009-0681-4.

  PMID: 19760046 BACKGROUND

• Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.

  PMID: 22290456 BACKGROUND

• Ogbadua AO, Agida TE, Akaba GO, Akitoye OA, Ekele BA. Early Versus Delayed Oral Feeding after Uncomplicated Cesarean Section under Spinal Anesthesia: A Randomized Controlled Trial. Niger J Surg. 2018 Jan-Jun;24(1):6-11. doi: 10.4103/njs.NJS_26_17.

  PMID: 29643726 BACKGROUND

• Osland E, Yunus R, Khan S, Memon MA. Early enteral nutrition within 24 h of intestinal surgery versus later commencement of feeding: a systematic review and meta-analysis. J Gastrointest Surg. 2009 Jun;13(6):1163-5; author reply 1166-7. doi: 10.1007/s11605-009-0846-2. Epub 2009 Mar 6. No abstract available.

  PMID: 19266244 BACKGROUND

• Stoppe C, Goetzenich A, Whitman G, Ohkuma R, Brown T, Hatzakorzian R, Kristof A, Meybohm P, Mechanick J, Evans A, Yeh D, McDonald B, Chourdakis M, Jones P, Barton R, Tripathi R, Elke G, Liakopoulos O, Agarwala R, Lomivorotov V, Nesterova E, Marx G, Benstoem C, Lemieux M, Heyland DK. Role of nutrition support in adult cardiac surgery: a consensus statement from an International Multidisciplinary Expert Group on Nutrition in Cardiac Surgery. Crit Care. 2017 Jun 5;21(1):131. doi: 10.1186/s13054-017-1690-5.

  PMID: 28583157 BACKGROUND

• Stoppe C, Whitlock R, Arora RC, Heyland DK. Nutrition support in cardiac surgery patients: Be calm and feed on! J Thorac Cardiovasc Surg. 2019 Oct;158(4):1103-1108. doi: 10.1016/j.jtcvs.2019.02.132. Epub 2019 May 7. No abstract available.

  PMID: 31202453 BACKGROUND

• Tatsuishi W, Kohri T, Kodera K, Asano R, Kataoka G, Kubota S, Nakano K. Usefulness of an enhanced recovery after surgery protocol for perioperative management following open repair of an abdominal aortic aneurysm. Surg Today. 2012 Dec;42(12):1195-200. doi: 10.1007/s00595-012-0252-3. Epub 2012 Jul 14.

  PMID: 22797961 BACKGROUND

• Visser M, Davids M, Verberne HJ, Kok WE, Tepaske R, Cocchieri R, Kemper EM, Teerlink T, Jonker MA, Wisselink W, de Mol BA, van Leeuwen PA. Nutrition before, during, and after surgery increases the arginine:asymmetric dimethylarginine ratio and relates to improved myocardial glucose metabolism: a randomized controlled trial. Am J Clin Nutr. 2014 Jun;99(6):1440-9. doi: 10.3945/ajcn.113.075473. Epub 2014 Apr 2.

  PMID: 24695897 BACKGROUND

• Voutilainen A, Pitkaaho T, Kvist T, Vehvilainen-Julkunen K. How to ask about patient satisfaction? The visual analogue scale is less vulnerable to confounding factors and ceiling effect than a symmetric Likert scale. J Adv Nurs. 2016 Apr;72(4):946-57. doi: 10.1111/jan.12875. Epub 2015 Dec 22.

  PMID: 26689434 BACKGROUND

• Deane AM, Ali Abdelhamid Y, Plummer MP, Fetterplace K, Moore C, Reintam Blaser A. Are Classic Bedside Exam Findings Required to Initiate Enteral Nutrition in Critically Ill Patients: Emphasis on Bowel Sounds and Abdominal Distension. Nutr Clin Pract. 2021 Feb;36(1):67-75. doi: 10.1002/ncp.10610. Epub 2020 Dec 9.

  PMID: 33296117 BACKGROUND

• Bours GJ, Speyer R, Lemmens J, Limburg M, de Wit R. Bedside screening tests vs. videofluoroscopy or fibreoptic endoscopic evaluation of swallowing to detect dysphagia in patients with neurological disorders: systematic review. J Adv Nurs. 2009 Mar;65(3):477-93. doi: 10.1111/j.1365-2648.2008.04915.x.

  PMID: 19222645 BACKGROUND

• Phothikun, N., Thitisakulchai, P., Tanvijit, P., & Yuyen, T. (2022). The incidence and risk factors of post-extubation dysphagia in critically ill surgical patients: protocol for prospective observational study. Clinical Critical Care, 30. https://doi.org/10.54205/ccc.v30.254965

  BACKGROUND

Study Officials

• Siddiha P Shahulhameed

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siddiha P Shahulhameed

CONTACT

+97431441488; sshahulhameed@hamad.qa

Amr S Elsid

CONTACT

+97466480831; AELSID@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open label randomized controlled trial with two parallel groups. No blinding will be considered.Patients will be randomly assigned to either early or conventional oral feeding group using software STATA 17.0 or SPSS 24.0. Sequentially numbered opaque sealed envelopes (SNOSE) which contain the allocation will be used. These envelopes are prepared by an independent person who is not a research team member. It will be sealed and provided to the principal investigator or co-investigator or statistician.Subjects will be enrolled as per the inclusion criteria. The patients will be approached directly in the preoperative period and informed consent will be obtained. They will be allocated to early and conventional diet groups by randomization.

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 24, 2023
• Study Start: December 12, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 9, 2024

Record last verified: 2023-11

Locations

QA (1)