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Optimal Collection of Specimens of the Lower Respiratory Tract

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ClinicalTrials.gov Identifier: NCT04595526
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Southern Denmark

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.


Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Procedure: Forced expiratory technique and induced sputum Procedure: Tracheal suction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Optimal Collection of Specimens of the Lower Respiratory Tract
Actual Study Start Date : November 9, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Active Comparator: Tracheal suction
Uses the local standard procedure of tracheal suction to obtain secretions from the lower respiratory tract
Procedure: Tracheal suction
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.

Experimental: Forced expiratory technique and induced sputum
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
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.




Primary Outcome Measures :
  1. Quality of specimen from the lower respiratory tract [ Time Frame: From collection to culture results - up to 5 days ]
    Unsuitable (bad quality) measured by microscopy - ≥ 10 squamous epithelial cells and < than 25 polymorphonuclear leucocytes per low power field of view (x10) Suitable (good quality) measured by microscopy - Samples with ≤ 10 squamous epithelial cells and > than 25 polymorphonuclear leucocytes per low power field of view


Secondary Outcome Measures :
  1. Density of microorganisms [ Time Frame: From collection to culture results - up to 5 days ]
    Assessed as number of colony forming units per millilitre with a cut off of 10^5 assessed semi-quantitatively as either numerous, some, or few or none.

  2. Patient clinical symptoms [ Time Frame: Patients are followed before intervention and 10 minutes after intervention ]
    The patients are asked about 4 specific symptoms (Cough, Expectoration, Chest pain and Dyspnea). The clinical symptoms are measured as following: yes/no/yes worse than usual. Ten minutes after the intervention they will be asked the same questions with yes/no/worse than before the intervention.

  3. Respiratory rate [ Time Frame: Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention) ]
    This will be counted by the health professional attending the patient and is the number of breaths per minute in rest. It is assessed by counting the number of times the patients chest rises in a half minute multiplied by 2.

  4. Oxygen saturation [ Time Frame: Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention) ]
    This is measured using a pulse oximetry device - a non-invasive method to measure artieral oxygen saturation level in percentages

  5. Patient well-being and experience of procedure [ Time Frame: Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention) ]
    Measured using the Borg Categorical rate 10 scale and a single likert-scale question - 'How does the patient experience the procedure' (only measured after the intervention).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 days
  • Patient which consent cannot be obtained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595526


Contacts
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Contact: Mariana Cartuliares +45 23434441 Mariana.Cartuliares@rsyd.dk
Contact: Helene Skjøt-Arkil, PhD + 45 7997 1113 Helene.Skjoet-Arkil@rsyd.dk

Locations
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Denmark
Hospital of Southern Jutland Recruiting
Aabenraa, Denmark
Contact: Christian B Mogensen, MD         
Sponsors and Collaborators
University of Southern Denmark
Investigators
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Study Chair: Christian Backer Mogensen, MD PhD University Hospital of Southern Denmark
Publications:

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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT04595526    
Other Study ID Numbers: SHS-ED-08-2020
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases