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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

End-Tidal CO2 (etCO2) and pH in the Correct Naso-gastric Tube Placement

Clinicaltrials.gov identifier NCT03934515

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted July 15, 2020

Study Description

Brief summary:

The laying of a naso-gastric tube is an extremely common event in intensive medicine; although standard naso-gastric tube laying is performed at the patient's bedside, this procedure is not without risk. Through the use of methods already used in the clinical field, of daily use, we want to identify the threshold value between tracheal and esophageal etCO2 (group A) and the threshold value between gastric and esophageal pH (group B).

  • Condition or Disease:pH
    Gastric Feeding Tube
    Blood Gas Monitoring, Transcutaneous
  • Intervention/Treatment: Other: etCO2
    Other: pH
  • Phase: N/A
Detailed Description

Numerous methodologies have been evaluated to recognize the correct positioning of NGT at the gastric level, including different clinical techniques (such as gastric auscultation, aspiration of the NGT), ultrasound techniques, etc. Actually, the diagnostic gold standard is the thoraco-abdominal anterior-posterior radiography, which is considered the only non-invasive method capable to confirm the correct pose of the NGT at intra-diaphragmatic level. This method, however, even if it is non-invasive, requires the use of ionizing radiation (4 micro-Sievert (uSv) for radiography) which could be repeated multiple time for the same patient; NGT may need to be repositioned several times during the same hospital stay, increasing patient exposure to ionizing radiation and, potentially, also the health workers exposure. The aim is to identify into the group A the threshold value between tracheal and esophageal etCO2 and into the group B the theshold value between gastric and esophageal pH. Phase A: etCO2 measurement will be collected 1. after intubation, when the tube is inserted into the endotracheal tube, before proceeding with the aspiration of secretions and 2. once the NGT has been inserted, by a probe located at the end of the tube. Phase B: pH measurement will be collected at the end of the procedure, once the NGT is inserted, at 1.a distance of 25 cm from the mouth (oesophageal site) and at 2. a distance of 40 cm (gastric site), aspirating the gastric contents and measuring on specific litmus paper.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 75 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: Tracheal etCO2 Level and Gastric pH Level Measurements During the Correct Naso-gastric Tube Placement in Unconscious Patients. A Physiological, Prospective, Observational Study
  • Estimated Study Start Date: January 2021
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: August 2021
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Group A - etCO2
At the end of the anaesthesia , as usual, the secretions are aspirated with a suction tube of 18 Fr of caliber (diameter 6 mm). When the tube is inserted into the endotracheal tube, before proceeding with the aspiration of the secretions, a capnometer is attached to its outer end, measuring the etCO2 value for 10-15 seconds. At the end of the measurement, authors proceed with the aspiration of the secretions as usual. Authors then proceed with the laying of a NGT according to local protocols. Also in this case, once the NGT has been inserted, the etCO2 is measured at the end of the probe for 10-15 seconds. At the end of the measurement, the capnometer can be detached, as a standard procedure, and the NGT can be used as usual. At the end of the procedure, therefore, for each patient, two values of etCO2 are acquired which will allow to obtain two "populations of values" of the etCO2: the values recorded at the endotracheal level and the one recorded at the oesophageal level.
Other: etCO2
At the end of the procedure, therefore, for each patient two values of etCO2 are acquired which will allow to obtain two "populations of values" of the etCO2: the values at the endotracheal level and the esophageal level values. The authors will find the "threshold value" of etCO2 collected when the NGT is well positioned in trachea. The study manager is not directly involved in the measurement and recording of etCO2 values.
: Group B - pH
At the end of the anaesthesia , once the NGT is inserted, the pH is measured by aspirating the gastric contents and measuring on specific litmus paper the pH values, both at a distance of 25 cm from the mouth (oesophageal site) and at a distance of 40 cm (gastric site). At the end of the procedure, for each patient two values of pH are acquired which will allow to obtain two pH "value populations": a value at oesophageal level and a value at the gastric level.
Other: pH
At the end of the procedure, for each patient two values of pH are acquired which will allow to obtain two pH "value populations": a value at esophageal level and a value at the gastric level. The authors will find the "threshold value" of pH collected when the NGT is positioned in the esophagus and in the stomach. The study manager is not directly involved in the measurement and recording of pH values.
Outcome Measures
  • Primary Outcome Measures: 1. etCO2 level [ Time Frame: 30-60 seconds ]
    to find a threshold value of etCO2 collected when the NGT is well positioned in trachea
  • 2. pH [ Time Frame: 30-60 seconds ]
    to find a threshold value of pH collected when the NGT is positioned in the esophagus and in the stomach.
  • Secondary Outcome Measures: 1. etCO2 level in chronic obstructive pulmonary disease (COPD) patients [ Time Frame: 30-60 seconds ]
    subanalysis for the threshold value in the group with chronic obstructive pulmonary disease (COPD)
  • 2. pH in patients taking proton pump inhibitors (PPIs) [ Time Frame: 30-60 seconds ]
    identify patients taking proton pump inhibitors (PPIs) and perform a sub-subanalysis for the threshold value in the group with already diagnosed gastro-esophageal reflux disease.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: patients who required a NGT placement in Clinica Luganese Moncucco and in Regional Hospital of Bellinzona who will signed the Informed Consent Form
Criteria

Inclusion criteria:

- Adult patients (> 18 years)

- Patients male and female

- Patients intubated by oro- or naso-tracheal way

- Post-induction curarized patients

- Fasting patients (from at least 6 hours)

Exclusion criteria:

- Patient refusal

- Patients with known bleeding diathesis / ongoing bleeding

- Patients at risk of bleeding (defined as thrombocytes <50 G/l, fibrinogen 2.5, activated partial thromboplastin time
(aPTT) > 70 sec)

- Patients with traumatic brain injury / Polytrauma

- Patients with esophagus-tracheal fistulas or malformations of the ear, nose, and
throat (ENT) sphere

- Patients with current or previous radiotherapy of the ENT sphere

- Patients unable to give their informed consent due to language barriers

- Women who are pregnant

Contacts and Locations
Contacts

Contact: Samuele Ceruti, MD 0041 091 960 ext 8108 samuele.ceruti@moncucco.ch

Contact: Maira Biggiogero, PhD 0041 091 960 ext 8666 maira.biggiogero@moncucco.ch

Locations

Switzerland
Clinica Luganese Moncucco
Lugano

Sponsors and Collaborators

Clinica Luganese Moncucco

Ospedale Regionale Bellinzona e Valli

Investigators

Principal Investigator: Samuele Ceruti, MD Clinica Luganese Moncucco

More Information