| Condition or disease | Intervention/treatment |
|---|---|
| Gastric Feeding Tube Blood Gas Monitoring, Transcutaneous pH | Other: etCO2 Other: pH |
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 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 |
| Actual Study Start Date : | November 1, 2020 |
| Actual Primary Completion Date : | April 1, 2021 |
| Estimated Study Completion Date : | August 1, 2021 |
| Group/Cohort | 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.
Other Name: Group A
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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.
Other Name: Phase B
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| 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 |
Inclusion criteria:
Exclusion criteria:
| 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 |
| Switzerland | |
| Clinica Luganese Moncucco | Recruiting |
| Lugano, Switzerland, 6900 | |
| 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 | |
| Sub-Investigator: Andrea Saporito, MD | |
| Principal Investigator: | Samuele Ceruti, MD | Clinica Luganese Moncucco |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 26, 2019 | ||||||||
| First Posted Date | May 2, 2019 | ||||||||
| Last Update Posted Date | April 23, 2021 | ||||||||
| Actual Study Start Date | November 1, 2020 | ||||||||
| Actual Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
etCO2 level [ Time Frame: 30-60 seconds ] To identify, for both groups of patients, the threshold value between the two populations of values that are found for etCO2.
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| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
etCO2 level in COPD patients [ Time Frame: 30-60 seconds ] subanalysis for the threshold value in the group with COPD
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | End-Tidal CO2 (etCO2) and pH in the Correct Naso-gastric Tube Placement | ||||||||
| 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 | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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 | ||||||||
| Condition |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
75 | ||||||||
| Original Estimated Enrollment |
50 | ||||||||
| Estimated Study Completion Date | August 1, 2021 | ||||||||
| Actual Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion criteria:
Exclusion criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | Switzerland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03934515 | ||||||||
| Other Study ID Numbers | CLM_ICU_001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Samuele Ceruti, Clinica Luganese Moncucco | ||||||||
| Study Sponsor | Clinica Luganese Moncucco | ||||||||
| Collaborators | Ospedale Regionale Bellinzona e Valli | ||||||||
| Investigators |
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| PRS Account | Clinica Luganese Moncucco | ||||||||
| Verification Date | April 2021 | ||||||||