Influence of Postoperative Bronchoscopy on Pulmonary Complications After Anatomical Lung Resections.

NCT03307018 | Recruiting

• 1 other identifier: TH-17-BR-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory complications are the largest group of complications following anatomical lung resections. Most of these complications result from a disrupted evacuation of respiratory secretions. At present, prevention of such complications involve: aspirating of secretions with a catheter during surgery through an intubation tube, active postoperative rehabilitation, mucolytic treatment and effective postoperative pain management. Suctioning of secretions by a catheter through an intubation tube does not, however, allow for removal of secretions from entire bronchial tree. Bronchofiberoscopy with a small-diameter flexible bronchoscope and thorough, systematic aspiration of secretions from respiratory tract immediately after surgery could presumably result in more effective bronchial cleansing and reduce risk of respiratory complications after surgery. Although the British Thoracic Society guidelines do not recommend routine bronchoscopy as a standard postoperative management after lung resections, they are based on a single, randomized, study analyzing a small group of patients. Bronchoscopy with systematic aspiration of secretions done with a thin flexible scope is a safe procedure, without risk of complications. It does not cause any additional discomfort to the patients and allows for much more accurate aspiration of the bronchial secretions than with a catheter inserted blindly through an intubation tube. It also gives an opportunity to directly evaluate segmental and subsegmental bronchial patency. This is particularly important in patients with COPD who tend to accumulate large amounts of mucus secretion in the bronchial tree.

Conditions

Postoperative Complications; Thoracic Surgery

Keywords

Bronchoscopy; Respiratory Complications; Anatomical Lung Resection

Outcome Measures

Primary Outcomes (1)

• Atelectasis.

  Occurrence of atelectasis on chest X-ray.

  Up to 3 days after surgery.

Secondary Outcomes (3)

• Bronchial Secretion Retention Related Complications Score (BRCS).

  Up to 3 days after surgery.

• Atrial fibrillation.

  Up to 3 days after surgery.

• CRP.

  72 hours after the end of surgery.

Study Arms (2)

Bronch

EXPERIMENTAL

Postoperative systematic bronchial aspiration.

Procedure: Postoperative systematic bronchial aspiration.

Control

NO INTERVENTION

In this arm bronchial aspiration with bronchoscope will not be done.

Interventions

Postoperative systematic bronchial aspiration. PROCEDURE

Postoperative flexible bronchoscopy and systematic bronchial aspiration.

Bronch

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pulmonary lobectomy.
• Patients must be informed and must sign and give written informed consent.

You may not qualify if:

• Wedge resection, segmentectomy, pneumonectomy.

Sponsors & Collaborators

• Wielkopolskie Centrum Pulmonologii i Torakochirurgii: lead

Study Sites (1)

Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Poznan, Wielkopolska, 62-007, Poland

RECRUITING

Related Publications (3)

• Jaworski A, Goldberg SK, Walkenstein MD, Wilson B, Lippmann ML. Utility of immediate postlobectomy fiberoptic bronchoscopy in preventing atelectasis. Chest. 1988 Jul;94(1):38-43. doi: 10.1378/chest.94.1.38.

  PMID: 3289837 BACKGROUND

• Du Rand IA, Barber PV, Goldring J, Lewis RA, Mandal S, Munavvar M, Rintoul RC, Shah PL, Singh S, Slade MG, Woolley A; BTS Interventional Bronchoscopy Guideline Group. Summary of the British Thoracic Society guidelines for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax. 2011 Nov;66(11):1014-5. doi: 10.1136/thoraxjnl-2011-201052.

  PMID: 22003155 BACKGROUND

• Stolz AJ, Schutzner J, Lischke R, Simonek J, Harustiak T, Pafko P. Predictors of atelectasis after pulmonary lobectomy. Surg Today. 2008;38(11):987-92. doi: 10.1007/s00595-008-3767-x. Epub 2008 Oct 29.

  PMID: 18958555 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Piotr Gabryel, MD

  Wielkopolskie Centrum Pulmonologii i Torakochirurgii

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Łukasz Gąsiorowski, MD

CONTACT

+48608390066; luke_gas@hotmail.com

Cezary Piwkowski, Prof

CONTACT

cezary_p@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 11, 2017
• Study Start: April 8, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)