Optimal Collection of Specimens of the Lower Respiratory Tract

NCT04595526 | Completed

• 1 other identifier: SHS-ED-08-2020
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory tract infection is a serious condition causing 3 million deaths worldwide every year. Approximately 20-40% of patients with community-acquired pneumonia are hospitalised. Treatment of pneumonia should be initiated as quickly as possible and therefore an early and precise diagnostic is extremely important. Imprecise or delayed diagnosis often results in overconsumption of broad-spectrum antibiotics that contribute to the development of antibiotic resistance. Unspecific symptoms, unsure diagnosis methods and a wait time of up to several days for results challenge a quick and effective diagnosis and treatment of pneumonia. Microbiological analysis of sputum samples is used to identify pathogens causative to pneumonia. However, obtaining specimens of good quality is challenging and affects the sensitivity and specificity of the results. Therefore, the identification of the optimal sputum collecting method is needed to ensure an improved identification process of the pathogen causing pneumonia. The purpose of this study is to determine the most optimal method for obtaining good quality sputum samples when comparing tracheal suction to methods without suction. A more accurate diagnosis will lead to more appropriate antibiotic consumption and will reduce the general development of antibiotic resistance.

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Quality of specimen from the lower respiratory tract

  Unsuitable (bad quality) measured by microscopy - \> 10 squamous epithelial cells per low power field of view (x10). Suitable (good quality) measured by microscopy - Samples with \< 10 squamous epithelial cells per low power field of view

  From collection to culture results - up to 5 days

Secondary Outcomes (8)

• Patient clinical symptoms

  Patients are followed before intervention and 10 minutes after intervention

• Respiratory rate

  Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention)

• Oxygen saturation

  Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention)

• Patient well-being and experience of procedure

  Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention)

• Occurrence of side effects

  Registered up to 1 hour after intervention

Study Arms (2)

Tracheal suction

ACTIVE COMPARATOR

Uses the local standard procedure of tracheal suction to obtain secretions from the lower respiratory tract

Procedure: Tracheal suction

Forced expiratory technique and induced sputum

EXPERIMENTAL

This procedure is without suction. The patient's attempts to deliver a sputum sample after forced exhalation and coughing technique. Regardless of the result the patient then receives hypertonic saline by an inhalation mask to induce the sputum. If the patient cannot deliver a sample, tracheal suction will be performed in order to obtain a specimen for the analyses.

Procedure: Forced expiratory technique and induced sputum

Interventions

Forced expiratory technique and induced sputum PROCEDURE

The intervention is based on the patient's own attempt to deliver a sputum sample after instructions of proper huff forced exhalation and coughing technique. After an attempt to deliver a sputum sample the patient will receive a 0,9% isotonic saline by an inhalation mask to induce the sputum, thereafter the patient will again make an effort to expectorate a sputum sample repeating the forced expiratory technique.

Forced expiratory technique and induced sputum

Tracheal suction PROCEDURE

Tracheal suction is often used on intubated patients at the intensive care unit to collect sputum, and this method has become the standard procedure at several emergency departments.

Tracheal suction

Eligibility Criteria

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

You may qualify if:

• Patients admitted with suspected lower respiratory tract infection
• Patients \> 18 years old
• One of the following symptoms: dyspnea, cough, expectoration, fever and chest tightness

You may not qualify if:

• Patients transferred directly to ICU
• If the attending physician considers emergency treatment is needed
• Patients receiving prednisolone treatment of 20mg/day or more over the last 2 weeks
• Patient which consent cannot be obtained

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Related Publications (10)

• Overend TJ, Anderson CM, Brooks D, Cicutto L, Keim M, McAuslan D, Nonoyama M. Updating the evidence-base for suctioning adult patients: a systematic review. Can Respir J. 2009 May-Jun;16(3):e6-17. doi: 10.1155/2009/872921.

  PMID: 19557211 BACKGROUND

• Skjot-Arkil H, Mogensen CB, Lassen AT, Johansen IS, Chen M, Petersen P, Andersen KV, Ellermann-Eriksen S, Moller JM, Ludwig M, Fuglsang-Damgaard D, Nielsen FE, Petersen DB, Jensen US, Rosenvinge FS. Carrier prevalence and risk factors for colonisation of multiresistant bacteria in Danish emergency departments: a cross-sectional survey. BMJ Open. 2019 Jun 27;9(6):e029000. doi: 10.1136/bmjopen-2019-029000.

  PMID: 31253624 BACKGROUND

• Meehan TP, Fine MJ, Krumholz HM, Scinto JD, Galusha DH, Mockalis JT, Weber GF, Petrillo MK, Houck PM, Fine JM. Quality of care, process, and outcomes in elderly patients with pneumonia. JAMA. 1997 Dec 17;278(23):2080-4.

  PMID: 9403422 BACKGROUND

• Karakioulaki M, Stolz D. Biomarkers and clinical scoring systems in community-acquired pneumonia. Ann Thorac Med. 2019 Jul-Sep;14(3):165-172. doi: 10.4103/atm.ATM_305_18.

  PMID: 31333765 BACKGROUND

• Savvateeva EN, Rubina AY, Gryadunov DA. Biomarkers of Community-Acquired Pneumonia: A Key to Disease Diagnosis and Management. Biomed Res Int. 2019 Apr 30;2019:1701276. doi: 10.1155/2019/1701276. eCollection 2019.

  PMID: 31183362 BACKGROUND

• Saukkoriipi A, Palmu AA, Jokinen J. Culture of all sputum samples irrespective of quality adds value to the diagnosis of pneumococcal community-acquired pneumonia in the elderly. Eur J Clin Microbiol Infect Dis. 2019 Jul;38(7):1249-1254. doi: 10.1007/s10096-019-03536-9. Epub 2019 Apr 4.

  PMID: 30949897 BACKGROUND

• Miyashita N, Shimizu H, Ouchi K, Kawasaki K, Kawai Y, Obase Y, Kobashi Y, Oka M. Assessment of the usefulness of sputum Gram stain and culture for diagnosis of community-acquired pneumonia requiring hospitalization. Med Sci Monit. 2008 Apr;14(4):CR171-6.

  PMID: 18376343 BACKGROUND

• Murdoch DR. How best to determine causative pathogens of pneumonia. Pneumonia (Nathan). 2016 Apr 12;8:1. doi: 10.1186/s41479-016-0004-z. eCollection 2016.

  PMID: 28702281 BACKGROUND

• Herrero-Cortina B, Alcaraz V, Vilaro J, Torres A, Polverino E. Impact of Hypertonic Saline Solutions on Sputum Expectoration and Their Safety Profile in Patients with Bronchiectasis: A Randomized Crossover Trial. J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):281-289. doi: 10.1089/jamp.2017.1443. Epub 2018 Jun 7.

  PMID: 29878856 BACKGROUND

• Cartuliares MB, Skjot-Arkil H, Rosenvinge FS, Mogensen CB, Skovsted TA, Pedersen AK. Effectiveness of expiratory technique and induced sputum in obtaining good quality sputum from patients acutely hospitalized with suspected lower respiratory tract infection: a statistical analysis plan for a randomized controlled trial. Trials. 2021 Oct 2;22(1):675. doi: 10.1186/s13063-021-05639-1.

  PMID: 34600559 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Christian Backer Mogensen, MD PhD

  University Hospital of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: October 20, 2020
• Study Start: November 9, 2020
• Primary Completion: July 5, 2021
• Study Completion: August 5, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)