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

Tracheal etCO2 Level and Gastric pH Level Measurements During the Correct Naso-gastric Tube Placement in Unconscious Patients. A Physiological, Prospective, Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03934515
Acronym
NGT
Enrollment
85
Registered
2019-05-02
Start date
2020-11-01
Completion date
2021-08-01
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Gas Monitoring, Transcutaneous, Gastric Feeding Tube, pH

Keywords

naso-gastric tube, etCO2, pH

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).

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.

Interventions

OTHERetCO2

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.

OTHERpH

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.

Sponsors

Ospedale Regionale Bellinzona e Valli
CollaboratorOTHER
Clinica Luganese Moncucco
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 \<1.0 g/l, international normalized ratio (INR) \> 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

Design outcomes

Primary

MeasureTime frameDescription
etCO2 level30-60 secondsto find a threshold value of etCO2 collected when the NGT is well positioned in trachea
pH30-60 secondsto find a threshold value of pH collected when the NGT is positioned in the esophagus and in the stomach.

Secondary

MeasureTime frameDescription
etCO2 level in chronic obstructive pulmonary disease (COPD) patients30-60 secondssubanalysis for the threshold value in the group with chronic obstructive pulmonary disease (COPD)
pH in patients taking proton pump inhibitors (PPIs)30-60 secondsidentify 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026