A Prospective, Randomized trial of INitial management of well toleraTED but voluminous primary pneumothorax : The PRINTED trial

##plugins.themes.academic_pro.article.sidebar##

Published Sep 13, 2026
https://doi.org/10.62438/tunismed.v104i08.7182
Download
PDF
Vol. 104 No. 08 (2026): Tunis Med Aug 2026

##plugins.themes.academic_pro.article.main##

Chaima Habouria
Pulmonology department Pavilion 4 , Research Laboratory LR012SP04, Abderrahmen Mami hospital Ariana 2080, Faculty of medicine of Tunis,University of Tunis El manar,Tunis, Tunisia
Marwa Bougacha
Pulmonology department Pavilion 4 , Research Laboratory LR012SP04, Abderrahmen Mami hospital Ariana 2080, Faculty of medicine of Tunis,University of Tunis El manar,Tunis, Tunisia
Imen Bachouch
Pulmonology department Pavilion 4 , Research Laboratory LR012SP04, Abderrahmen Mami hospital Ariana 2080, Faculty of medicine of Tunis,University of Tunis El manar,Tunis, Tunisia
Fatma Chermiti
Pulmonology department Pavilion 4 , Research Laboratory LR012SP04, Abderrahmen Mami hospital Ariana 2080, Faculty of medicine of Tunis,University of Tunis El manar,Tunis, Tunisia
Soraya Fenniche
Pulmonology department Pavilion 4 , Research Laboratory LR012SP04, Abderrahmen Mami hospital Ariana 2080, Faculty of medicine of Tunis,University of Tunis El manar,Tunis, Tunisia
Nidhal Belloumi
Pulmonology department Pavilion 4 , Research Laboratory LR012SP04, Abderrahmen Mami hospital Ariana 2080, Faculty of medicine of Tunis,University of Tunis El manar,Tunis, Tunisia

Abstract

Introduction: Although needle aspiration (NA) has demonstrated comparable efficacy to chest tube drainage (CT) for primary spontaneous pneumothorax (PSP), its routine use remains limited, particularly for large PSP. This study aimed to assess the efficacy and safety of NA compared to CT in the initial management of large PSP in Tunisia.
Methods: We conducted a monocenter, prospective, randomized, open-label, non-inferiority trial at Abderrahmen Mami Hospital from 2019 to 2023. Eligible patients presented with a first episode of PSP occupying more than 40% of hemithorax volume (based on the Collins index) but were still clinically stable. Patients were randomly assigned to undergo either CT or NA. The first primary outcome was successful lung re-expansion. The second primary outcome was the recurrence rate during one year of follow up.
Results: A total of 77 patients were enrolled. NA (n= 34) was associated with a significantly shorter hospital stay, reduced analgesic use, and fewer iatrogenic complications than CT (n= 43). The overall success rate of NA was equivalent to that of CT (64.7% vs. 65.1%, p= 0.97). The absolute
difference in success rates was −0.4% (95% CI, [−3.9% to +4.7%], margin error-10%). Recurrence rates after one year were comparable in the two groups.
Conclusion: Needle aspiration is an effective and less invasive alternative to chest tube drainage for managing large but well-tolerated PSP. Wider adoption of this strategy could reduce the hospital burden and enhance patient care. Increased awareness among clinicians is essential to shift
established practices.

Keywords:

Primary spontaneous pneumothorax , Needle aspiration , Chest tube , Randomized controlled trial

##plugins.themes.academic_pro.article.details##

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

References

  1. Collins CD, Lopez A, Mathie A, Wood V, Jackson JE, Roddie ME. Quantification of pneumothorax size on chest radiographs using
  2. interpleural distances: regression analysis based on volume measurements from helical CT. AJR Am J Roentgenol. 1995
  3. Nov;165(5):1127–30. doi:10.2214/ajr.165.5.7572489 PubMed PMID: 7572489.
  4. Baumann MH, Strange C, Heffner JE, Light R, Kirby TJ, Klein J, et al. Management of spontaneous pneumothorax: an American College
  5. of Chest Physicians Delphi consensus statement. Chest. 2001 Feb;119(2):590–602. doi:10.1378/chest.119.2.590 PubMed PMID:
  6. MacDuff A, Arnold A, Harvey J, BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic
  7. Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi:10.1136/thx.2010.136986 PubMed PMID: 20696690.
  8. Wang C, Lyu M, Zhou J, Liu Y, Ji Y. Chest tube drainage versus needle aspiration for primary spontaneous pneumothorax: which
  9. is better? J Thorac Dis. 2017 Oct;9(10):4027–38. doi:10.21037/jtd.2017.08.140
  10. Noppen M, Alexander P, Driesen P, Slabbynck H, Verstraeten A. Manual Aspiration versus Chest Tube Drainage in First Episodes of
  11. Primary Spontaneous Pneumothorax. Am J Respir Crit Care Med. 2002 May 1;165(9):1240–4. doi:10.1164/rccm.200111-078OC
  12. Parlak M, Uil SM, Van Den Berg JWK. A prospective, randomised trial of pneumothorax therapy: Manual aspiration versus conventional chest tube drainage. Respir Med. 2012 Nov;106(11):1600–5. doi:10.1016/j.rmed.2012.08.005
  13. Joobeur S, Mhamed SC, Mribah H, Skhiri N, Rouetbi N, Kamel AE. Predictive factors of recurrence in spontaneous pneumothorax.
  14. Tunis Médicale [Internet]. 2015 Oct 27 [cited 2026 Jul 27];93(6). Available from: https://www.latunisiemedicale.com/index.php/
  15. tunismed/article/view/2835
  16. Fehri SM, Issaoui N, Kwas H. Profil clinique, thérapeutique et évolutif des pneumothorax spontanés. Tunis Médicale. 2025 Jun
  17. ;103(6). doi:10.62438/tunismed.v103i6.5660
  18. Brown SGA, Ball EL, Perrin K, Asha SE, Braithwaite I, Egerton- Warburton D, et al. Conservative versus Interventional Treatment
  19. for Spontaneous Pneumothorax. N Engl J Med. 2020 Jan 30;382(5):405–15. doi:10.1056/NEJMoa1910775
  20. Brown S, Ball E, Lee YCG, Beasley R, Simpson G, PSP Investigators. Management of primary spontaneous pneumothorax: less is more. Lancet Lond Engl. 2021 Dec 19;396(10267):1973. doi:10.1016/ S0140-6736(20)32674-X PubMed PMID: 33341134.
  21. Mohamed MMG, Patolia S, Nayak R. Needle aspiration versus tube thoracostomy in patients with symptomatic primary spontaneous
  22. pneumothorax: an updated meta-analysis of randomized controlled trials. J Thorac Dis. 2024 Jun 30;16(6). doi:10.21037/jtd-24-60
  23. Aguinagalde B, Zabaleta J, Fuentes M, Bazterargui N, Hernández C, Izquierdo JM, et al. Percutaneous aspiration versus tube drainage
  24. for spontaneous pneumothorax: systematic review and meta-analysis. Eur J Cardiothorac Surg. 2010 May 1;37(5):1129–35.
  25. doi:10.1016/j.ejcts.2009.12.008
  26. Jouneau S, Ricard JD, Seguin-Givelet A, Bigé N, Contou D, Desmettre T, et al. SPLF/SMFU/SRLF/SFAR/SFCTCV Guidelines for the
  27. management of patients with primary spontaneous pneumothorax. Ann Intensive Care. 2023 Sep 19;13(1):88. doi:10.1186/s13613-
  28. -01181-2 PubMed PMID: 37725198; PubMed Central PMCID: PMC10509123.
  29. Contou D, Razazi K, Katsahian S, Maitre B, Mekontso-Dessap A, Brun-Buisson C, et al. Small-bore catheter versus chest tube drainage
  30. for pneumothorax. Am J Emerg Med. 2012 Oct;30(8):1407–13. doi:10.1016/j.ajem.2011.10.014
  31. Desmettre T, Meurice JC, Mauny F, Woronoff MC, Tiffet O, Schmidt J, et al. Comparaison de l’efficacité d’une exsufflation
  32. simple par rapport au drainage thoracique dans le traitement du pneumothorax spontané complet. Étude EXPRED : EXsufflation
  33. d’un PREmier pneumothorax versus Drainage. Rev Mal Respir. 2011 Mar;28(3):336–43. doi:10.1016/j.rmr.2010.10.030
  34. Desmettre T, Meurice JC, Mauny F, Woronoff MC, Tiffet O, Schmidt J, et al. [Comparison of simple aspiration versus standard drainage
  35. in the treatment of large primary spontaneous pneumothorax]. Rev Mal Respir. 2011 Mar;28(3):336–43. doi:10.1016/j.rmr.2010.10.030
  36. PubMed PMID: 21482337.
  37. Zhu P, Xia H, Sun Z, Zhu D, Deng L, Zhang Y, et al. Manual aspiration versus chest tube drainage in primary spontaneous pneumothorax without underlying lung diseases: a meta-analysis of randomized controlled trials. Interact Cardiovasc Thorac Surg. 2019 Jun 1;28(6):936–44. doi:10.1093/icvts/ivy342
  38. Hallifax RJ. Cost Utility Analysis of Primary Spontaneous Pneumothorax Management: Another Reason to Choose Outpatient Options? CHEST. 2023 Oct 1;164(4):829–30. doi:10.1016/j.chest.2023.06.033 PubMed PMID: 37805243.
  39. Ayed AK. Suction versus water seal after thoracoscopy for primary spontaneous pneumothorax: prospective randomized study.
  40. Ann Thorac Surg. 2003 May;75(5):1593–6. doi:10.1016/s0003- 4975(02)04894-4 PubMed PMID: 12735584.
  41. Coughlin SM,Emmerton-Coughlin HMA, Malthaner R. Management of chest tubes after pulmonary resection: a systematic review
  42. and meta-analysis. Can J Surg J Can Chir. 2012 Aug;55(4):264–70. doi:10.1503/cjs.001411 PubMed PMID: 22854148; PubMed
  43. Central PMCID: PMC3404148.
  44. Korczyński P, Górska K, Nasiłowski J, Chazan R, Krenke R. Comparison of Small Bore Catheter Aspiration and Chest Tube Drainage in the Management of Spontaneous Pneumothorax. Adv Exp Med Biol. 2015;866:15–23. doi:10.1007/5584_2015_146 PubMed PMID:
  45. Brown SGA, Ball EL, Perrin K, Read CA, Asha SE, Beasley R, et al. Study protocol for a randomised controlled trial of invasive
  46. versus conservative management of primary spontaneous pneumothorax. BMJ Open. 2016 Sep;6(9):e011826. doi:10.1136/
  47. bmjopen-2016-011826
  48. Liu WL, Lv K, Deng HS, Hong QC. Comparison of efficiency and safety of conservative versus interventional management for
  49. primary spontaneous pneumothorax: A meta-analysis. Am J Emerg Med. 2021 Jul;45:352–7. doi:10.1016/j.ajem.2020.08.092 PubMed
  50. PMID: 33046307.
  51. Hung CS, Chen YC, Yang TF, Huang FH. Systematic review and meta-analysis on juvenile primary spontaneous pneumothorax:
  52. Conservative or surgical approach first? PLOS ONE. 2021 Apr 30;16(4):e0250929. doi:10.1371/journal.pone.0250929
  53. Chew R, Gerhardy B, Simpson G. Conservative versus invasive treatment of primary spontaneous pneumothorax: a retrospective
  54. cohort study. Acute Med Surg. 2014 Oct;1(4):195–9. doi:10.1002/ ams2.33