IntubationNCT04316988
Ultrasonography Versus Capnography in Detecting Endotracheal Tube Placement During Intubation in a Tertiary Hospital.
An observational study of Intubation and Ultrasound Imaging, run by Tribhuvan University, Nepal.
Trial summary
After endotracheal intubation verifying the location of endotracheal tube is of utmost importance. Many methods have been applied but none is perfect. The standard practice in the investigator's center has been to use auscultation of chest with capnography. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation, Ultrasound Imaging, Capnography
- What is being tested?
- Ultrasonography
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2017to 15 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: American Society of Anesthesiologist classified status I and II patients from Nepalsese population, without any selection for gender, caste or ethnicity, and above 16 years of age.
Who may be able to join
- ASA I and II patients of both sexes above 16 years of age undergoing general anaesthesia with endotracheal tube placement.
Who cannot join
- - Patient refusal
- ASA physical status III and above
- History of prior difficult bag and mask ventilation or difficult intubation
- History of prior oro-nasal or neck injuries, burns or scars
- Active oral, pharyngeal or tracheal infection or inflammatory changes
- Anticipated difficult airway or difficult intubation during preanaesthetic examination, with Mallampati grades II and above
- Lung parenchymal and pleural diseases. Examples: asthma, COPD, bronchiectasis, reactive lung diseases, pneumonia, tuberculosis, pleural effusion, pneumothorax, lung or pleural malignancy etc.
- Emergency surgery
About this study
Official title: Ultrasonography Imaging Versus Waveform Capnography in Detecting Endotracheal Tube Placement During Intubation in a Tertiary Hospital.
After endotracheal intubation verifying the location of endotracheal tube is of utmost importance. Many methods have been applied but none is perfect. The standard practice in the investigator's center has been to use auscultation of chest with capnography.
Ultrasound machines are now gaining popularity and their access extends from operation theatres, emergency rooms and even many primary health centres. Both capnography and ultrasonography are safe.
This study found out that Ultrasonography and waveform capnography are both reliable methods of confirming endotracheal tube position. The use of ultrasound could help reduce time and increase precision of confirming endotracheal tube position. Ultrasound can confirm endotracheal tube position before manual bag ventilations, and thus may prevent aspiration of gastric contents into patient's lungs.
Read the detailed description
This was a prospective, observational study conducted at the Tribhuvan University Teaching Hospital (TUTH) and Manmohan Cardiothoracic Vascular and Transplant Center (MCVTC) operating rooms from January 2017 to July 2017. Ethical approval from the Institutional Review Board (IRB) of Institute of Medicine (IOM) and the Department of Anaesthesiology, Maharajgunj Medical College (MMC) was taken. Written informed consent was taken.
ASA I and II patients over 16 years of age were included in this study. Patients with difficult airway and anticipated difficult intubation, respiratory diseases, poor functional status, emergency case, and patients at risk of aspiration were excluded.
The diagnostic characteristics of real-time, suprasternal, transtracheal ultrasonography and capnography were tested by calculating their respective sensitivities, specificities, positive predictive values (PPV), negative predictive values (NPV), accuracies and likelihood ratios. Comparison of time taken for confirmation of endotracheal tube position from the beginning of laryngoscopy, by ultrasonography versus capnography was done using t-statistics.
The degree of agreement of result between ultrasonography and capnography was tested with kappa statistics.
Out of the 95 patients studied, 11 had oesophageal intubation (Incidence of 11.57%). The overall accuracy of both ultrasonography and capnography was 96.84%. The sensitivity, specificity, PPV, NPV with their corresponding 95% confidence intervals (CI) for ultrasonography were 97.62% (91.66% - 99.71%), 90.91% (58.72% - 99.77%), 98.80% (92.67% - 99.81%), 83.33% (55.66% - 95.22%) respectively; and that for capnography were 96.43% (89.92% - 99.26%), 100% (71.51% - 100%), 100% (100% - 100%) and 78.57% (54.69% - 91.76%) respectively.
The likelihood ratio of a positive and a negative result for ultrasonography were 10.74 and 0.03 respectively, and that for capnography were infinity and 0.04 respectively.
The kappa value was 0.749 (95% CI: 0.567 - 0.931) which meant a good degree of agreement of result between these two methods.
The average time taken for confirmation of endotracheal tube by ultrasonography and capnography were 26.79 ± 7.64 seconds and 43.03 ± 8.71 seconds (mean ± standard deviation) respectively. The median time for confirmation was 26 seconds with interquartile range [15 - 37] seconds for ultrasonography and 42 seconds with interquartile range [29 - 55] seconds for capnography. Ultrasonography was found to be faster than capnography by 16.36 ± 3.23 seconds (mean ± standard deviation) and the difference in time was significant (p = 0.011).
During the study, one patient had unanticipated difficult intubation, and four had hypotension after induction of anaesthesia. These patients were excluded from the study and no sequalae of hypotension was seen in the patients, or no hypoxemia occured in the patient with unanticipated difficult intubation.
- Conditions
- Intubation, Ultrasound Imaging, Capnography
- Being tested
- Ultrasonography
- Keywords
- Endotracheal intubation; Ultrasonography; Capnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
A real time 2D ultrasound evaluation was done over the trachea of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography | Ultrasonography group in whom after endotracheal intubation, the endotracheal tube position was confirmed by ultrasound machine over the trachea. Receives: Diagnostic Test: Ultrasonography | |
| Capnography | Capnography group in whom after endotracheal intubation, the endotracheal tube position was confirmed by capnograph, evaluationg the graph character and end tidal CO2 value. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ULTRASONOGRAPHY IMAGING VERSUS WAVEFORM CAPNOGRAPHY IN DETECTING ENDOTRACHEAL TUBE PLACEMENT DURING INTUBATION IN A TERTIARY HOSPITAL
Ultrasonography and waveform capnography are both reliable and accurate methods of confirming endotracheal tube position
Measured: 6 months
Secondary outcomes (1)
Ultrasonography compared to capnography for confirming the endotacheal tube position after intuabtion
- Using real-time transtracheal ultrasound can help confirm endotracheal tube position earlier than capnography.
- Using real-time transtracheal ultrasound will help avoid manual bag ventilations to confirm endotracheal tube position and can prevent aspiration of gastric contents into lungs in cases of oesophageal intubation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start17 Jan 2017
- Primary completion14 Jul 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirish Shakti Maskay, Tribhuvan University, Nepal
- Investigators
- BISHWAS PRADHAN, MD, FCTA, Study chair, Manmohan Cardiothoracic Vascular and Transplant Center, IOMNINADINI SHRESTHA, MD, FIPM, Study director, TU Teaching Hospital, IOMPRISKA BASTOLA, MD, Study director, Manmohan Cardiothoracic Vascular and Transplant Center, IOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316988
- Sponsor's protocol ID
- IOM
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Excel worksheet of patients data log entry includes age, sex and type of surgery; without disclosing personal patient details.
Publications
Rudraraju P, Eisen LA. Confirmation of endotracheal tube position: a narrative review. J Intensive Care Med. 2009 Sep-Oct;24(5):283-92. doi: 10.1177/0885066609340501. Epub 2009 Aug 3.
PubMed 19654121Wojtczak JA, Cattano D. Laryngo-tracheal ultrasonography to confirm correct endotracheal tube and laryngeal mask airway placement. J Ultrason. 2014 Dec;14(59):362-6. doi: 10.15557/JoU.2014.0037. Epub 2014 Dec 30.
PubMed 26672974Kundra P, Mishra SK, Ramesh A. Ultrasound of the airway. Indian J Anaesth. 2011 Sep;55(5):456-62. doi: 10.4103/0019-5049.89868.
PubMed 22174461Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.
PubMed 24582925Hagberg CA, Artime CA. Airway Management in the Adult. In: Miller RD, Cohen NH, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's Anesthesia. 8th ed. Philadelphia: Elsevier Saunders; 2015. p. 1665-6.
Dorsch JA, Dorsch SE. Airway Equipment. In: Dorsch JA, Dorsch SE, editors. Understanding Anesthesia Equipment. 5th ed: Lippincott Williams and Wilkins; 2012. p. 593-8.
Rosenbalt WH, Sukhupragarn W. Airway Management. In: Barash PG, Cullen BF, Stoeltin RK, Cahalan MK, Stock MC, Ortega R, editors. Clinical Anesthesia. 7th ed. Philadelphia: Lipincott Williams and Wilkins; 2013. p. 774-8.
Connor CW. Commonly Used Monitoring Techniques. In: Barash PG, Cullen BF, Stoeltin RK, Cahalan MK, Stock MC, Ortega R, editors. Clinical Anesthesia. 7th ed. Philadelphia: Lippincott Williams and Wilkins; 2013. p. 704-6.
Chitilian HV, Kaczka DW, Melo MFV. Respiratory Monitoring. In: Miller RD, Cohen NH, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's Anesthesia. 8th ed. Philadelphia: Elsevier Saunders; 2015. p. 1551-5.
Chou HC, Tseng WP, Wang CH, Ma MH, Wang HP, Huang PC, Sim SS, Liao YC, Chen SY, Hsu CY, Yen ZS, Chang WT, Huang CH, Lien WC, Chen SC. Tracheal rapid ultrasound exam (T.R.U.E.) for confirming endotracheal tube placement during emergency intubation. Resuscitation. 2011 Oct;82(10):1279-84. doi: 10.1016/j.resuscitation.2011.05.016. Epub 2011 Jun 1.
PubMed 21684668Karacabey S, Sanri E, Gencer EG, Guneysel O. Tracheal ultrasonography and ultrasonographic lung sliding for confirming endotracheal tube placement: Speed and Reliability. Am J Emerg Med. 2016 Jun;34(6):953-6. doi: 10.1016/j.ajem.2016.01.027. Epub 2016 Jan 26.
PubMed 26994679Pfeiffer P, Rudolph SS, Borglum J, Isbye DL. Temporal comparison of ultrasound vs. auscultation and capnography in verification of endotracheal tube placement. Acta Anaesthesiol Scand. 2011 Nov;55(10):1190-5. doi: 10.1111/j.1399-6576.2011.02501.x. Epub 2011 Sep 8.
PubMed 22092123Das SK, Choupoo NS, Haldar R, Lahkar A. Transtracheal ultrasound for verification of endotracheal tube placement: a systematic review and meta-analysis. Can J Anaesth. 2015 Apr;62(4):413-23. doi: 10.1007/s12630-014-0301-z. Epub 2014 Dec 24.
PubMed 25537734Chou EH, Dickman E, Tsou PY, Tessaro M, Tsai YM, Ma MH, Lee CC, Marshall J. Ultrasonography for confirmation of endotracheal tube placement: a systematic review and meta-analysis. Resuscitation. 2015 May;90:97-103. doi: 10.1016/j.resuscitation.2015.02.013. Epub 2015 Feb 21.
PubMed 25711517Milling TJ, Jones M, Khan T, Tad-y D, Melniker LA, Bove J, Yarmush J, SchianodiCola J. Transtracheal 2-d ultrasound for identification of esophageal intubation. J Emerg Med. 2007 May;32(4):409-14. doi: 10.1016/j.jemermed.2006.08.022. Epub 2007 Apr 16.
PubMed 17499696
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Imaging Versus Waveform Capnography in Detecting Endotracheal Tube Placement During Intubation in a Tertiary Hospital.
- ClinicalTrials.gov ID
- NCT04316988
- Acronym / sponsor ID
- IOM
- Conditions
- Intubation, Ultrasound Imaging, Capnography
- Keywords
- Endotracheal intubation; Ultrasonography; Capnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Tribhuvan University, NepalUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After endotracheal intubation verifying the location of endotracheal tube is of utmost importance. Many methods have been applied but none is perfect. The standard practice in the investigator's center has been to use auscultation of chest with capnography.
Ultrasound machines are now gaining popularity and their access extends from operation theatres, emergency rooms and even many primary health centres. Both capnography and ultrasonography are safe.
This study found out that Ultrasonography and waveform capnography are both reliable methods of confirming endotracheal tube position. The use of ultrasound could help reduce time and increase precision of confirming endotracheal tube position. Ultrasound can confirm endotracheal tube position before manual bag ventilations, and thus may prevent aspiration of gastric contents into patient's lungs.
Detailed description
This was a prospective, observational study conducted at the Tribhuvan University Teaching Hospital (TUTH) and Manmohan Cardiothoracic Vascular and Transplant Center (MCVTC) operating rooms from January 2017 to July 2017. Ethical approval from the Institutional Review Board (IRB) of Institute of Medicine (IOM) and the Department of Anaesthesiology, Maharajgunj Medical College (MMC) was taken. Written informed consent was taken.
ASA I and II patients over 16 years of age were included in this study. Patients with difficult airway and anticipated difficult intubation, respiratory diseases, poor functional status, emergency case, and patients at risk of aspiration were excluded.
The diagnostic characteristics of real-time, suprasternal, transtracheal ultrasonography and capnography were tested by calculating their respective sensitivities, specificities, positive predictive values (PPV), negative predictive values (NPV), accuracies and likelihood ratios. Comparison of time taken for confirmation of endotracheal tube position from the beginning of laryngoscopy, by ultrasonography versus capnography was done using t-statistics.
The degree of agreement of result between ultrasonography and capnography was tested with kappa statistics.
Out of the 95 patients studied, 11 had oesophageal intubation (Incidence of 11.57%). The overall accuracy of both ultrasonography and capnography was 96.84%. The sensitivity, specificity, PPV, NPV with their corresponding 95% confidence intervals (CI) for ultrasonography were 97.62% (91.66% - 99.71%), 90.91% (58.72% - 99.77%), 98.80% (92.67% - 99.81%), 83.33% (55.66% - 95.22%) respectively; and that for capnography were 96.43% (89.92% - 99.26%), 100% (71.51% - 100%), 100% (100% - 100%) and 78.57% (54.69% - 91.76%) respectively.
The likelihood ratio of a positive and a negative result for ultrasonography were 10.74 and 0.03 respectively, and that for capnography were infinity and 0.04 respectively.
The kappa value was 0.749 (95% CI: 0.567 - 0.931) which meant a good degree of agreement of result between these two methods.
The average time taken for confirmation of endotracheal tube by ultrasonography and capnography were 26.79 ± 7.64 seconds and 43.03 ± 8.71 seconds (mean ± standard deviation) respectively. The median time for confirmation was 26 seconds with interquartile range [15 - 37] seconds for ultrasonography and 42 seconds with interquartile range [29 - 55] seconds for capnography. Ultrasonography was found to be faster than capnography by 16.36 ± 3.23 seconds (mean ± standard deviation) and the difference in time was significant (p = 0.011).
During the study, one patient had unanticipated difficult intubation, and four had hypotension after induction of anaesthesia. These patients were excluded from the study and no sequalae of hypotension was seen in the patients, or no hypoxemia occured in the patient with unanticipated difficult intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography | – | Diagnostic Test: UltrasonographyUltrasonography group in whom after endotracheal intubation, the endotracheal tube position was confirmed by ultrasound machine over the trachea. |
| Capnography | – | –Capnography group in whom after endotracheal intubation, the endotracheal tube position was confirmed by capnograph, evaluationg the graph character and end tidal CO2 value. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- American Society of Anesthesiologist classified status I and II patients from Nepalsese population, without any selection for gender, caste or ethnicity, and above 16 years of age.
Key inclusion criteria (1 listed)
- ASA I and II patients of both sexes above 16 years of age undergoing general anaesthesia with endotracheal tube placement.
Key exclusion criteria (8 listed)
- - Patient refusal
- ASA physical status III and above
- History of prior difficult bag and mask ventilation or difficult intubation
- History of prior oro-nasal or neck injuries, burns or scars
- Active oral, pharyngeal or tracheal infection or inflammatory changes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyA real time 2D ultrasound evaluation was done over the trachea of the patient. | Diagnostic test | Ultrasonography |
Primary outcome
ULTRASONOGRAPHY IMAGING VERSUS WAVEFORM CAPNOGRAPHY IN DETECTING ENDOTRACHEAL TUBE PLACEMENT DURING INTUBATION IN A TERTIARY HOSPITAL
Time frame: 6 months
Ultrasonography and waveform capnography are both reliable and accurate methods of confirming endotracheal tube position
1 secondary outcome
Ultrasonography compared to capnography for confirming the endotacheal tube position after intuabtion
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Background: PubMed 19654121Rudraraju P, Eisen LA. Confirmation of endotracheal tube position: a narrative review. J Intensive Care Med. 2009 Sep-Oct;24(5):283-92. doi: 10.1177/0885066609340501. Epub 2009 Aug 3.
- Background: PubMed 26672974Wojtczak JA, Cattano D. Laryngo-tracheal ultrasonography to confirm correct endotracheal tube and laryngeal mask airway placement. J Ultrason. 2014 Dec;14(59):362-6. doi: 10.15557/JoU.2014.0037. Epub 2014 Dec 30.
- Background: PubMed 22174461Kundra P, Mishra SK, Ramesh A. Ultrasound of the airway. Indian J Anaesth. 2011 Sep;55(5):456-62. doi: 10.4103/0019-5049.89868.
- Background: PubMed 24582925Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.
- BackgroundHagberg CA, Artime CA. Airway Management in the Adult. In: Miller RD, Cohen NH, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's Anesthesia. 8th ed. Philadelphia: Elsevier Saunders; 2015. p. 1665-6.
- BackgroundDorsch JA, Dorsch SE. Airway Equipment. In: Dorsch JA, Dorsch SE, editors. Understanding Anesthesia Equipment. 5th ed: Lippincott Williams and Wilkins; 2012. p. 593-8.
- BackgroundRosenbalt WH, Sukhupragarn W. Airway Management. In: Barash PG, Cullen BF, Stoeltin RK, Cahalan MK, Stock MC, Ortega R, editors. Clinical Anesthesia. 7th ed. Philadelphia: Lipincott Williams and Wilkins; 2013. p. 774-8.
- BackgroundConnor CW. Commonly Used Monitoring Techniques. In: Barash PG, Cullen BF, Stoeltin RK, Cahalan MK, Stock MC, Ortega R, editors. Clinical Anesthesia. 7th ed. Philadelphia: Lippincott Williams and Wilkins; 2013. p. 704-6.
- BackgroundChitilian HV, Kaczka DW, Melo MFV. Respiratory Monitoring. In: Miller RD, Cohen NH, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's Anesthesia. 8th ed. Philadelphia: Elsevier Saunders; 2015. p. 1551-5.
- Results publication: PubMed 21684668Chou HC, Tseng WP, Wang CH, Ma MH, Wang HP, Huang PC, Sim SS, Liao YC, Chen SY, Hsu CY, Yen ZS, Chang WT, Huang CH, Lien WC, Chen SC. Tracheal rapid ultrasound exam (T.R.U.E.) for confirming endotracheal tube placement during emergency intubation. Resuscitation. 2011 Oct;82(10):1279-84. doi: 10.1016/j.resuscitation.2011.05.016. Epub 2011 Jun 1.
- Results publication: PubMed 26994679Karacabey S, Sanri E, Gencer EG, Guneysel O. Tracheal ultrasonography and ultrasonographic lung sliding for confirming endotracheal tube placement: Speed and Reliability. Am J Emerg Med. 2016 Jun;34(6):953-6. doi: 10.1016/j.ajem.2016.01.027. Epub 2016 Jan 26.
- Results publication: PubMed 22092123Pfeiffer P, Rudolph SS, Borglum J, Isbye DL. Temporal comparison of ultrasound vs. auscultation and capnography in verification of endotracheal tube placement. Acta Anaesthesiol Scand. 2011 Nov;55(10):1190-5. doi: 10.1111/j.1399-6576.2011.02501.x. Epub 2011 Sep 8.
- Individual participant dataSharing planned: Yes. Excel worksheet of patients data log entry includes age, sex and type of surgery; without disclosing personal patient details.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BISHWAS PRADHAN, MD, FCTA study chair
Manmohan Cardiothoracic Vascular and Transplant Center, IOM
NINADINI SHRESTHA, MD, FIPM study director
TU Teaching Hospital, IOM
PRISKA BASTOLA, MD study director
Manmohan Cardiothoracic Vascular and Transplant Center, IOM
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation and Ultrasound Imaging, run by Tribhuvan University, Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ULTRASONOGRAPHY IMAGING VERSUS WAVEFORM CAPNOGRAPHY IN DETECTING ENDOTRACHEAL TUBE PLACEMENT DURING INTUBATION IN A TERTIARY HOSPITAL (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316988, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.