Robotic Surgical ProceduresNCT04440787
Prevention of Endotracheal Tube Migration by Cuff Palpation During Robotic Surgical Procedure
An observational study of Robotic Surgical Procedures, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
After intubation, the endotracheal tube was finally fixed after palpating endotracheal cuff at three sites (just below the cricoid cartilage, at suprasternal level and just below suprasternal notch). Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Robotic Surgical Procedures
- What is being tested?
- Three point cuff palpation technique
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2018to 31 Mar 2021
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing the robotic urological or gynecological surgery in Trendelenburg position with pneumoperitoneum will be included in the study cohort.
Who may be able to join
- Robotic uro-oncological surgical procedures of perineum
- Robotic gynae-oncological surgical procedures of perineum
Who cannot join
- Upper airway fibrosis or tracheal stenosis
- Large neck swelling distorting or deviating the trachea.
- Head and neck surgeries
- Laryngeal and tracheal tumour
- Tracheal surgery
- Previous tracheostomy
- previous radiation treatment of neck
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Rajiv Gandhi Cancer Institute & Research center
Rohini, New Delhi, 110085
Amit kr Mittal, M.D, 91-9717611416, amitrgci@gmail.com
Mamta Dubey, M.D, 91-98911105744, ek_mamta@yahoo.co.in
About this study
Official title: To Evaluate "Three Point Cuff Palpation Technique" for Assessing Optimal Depth of Endotracheal Tube Placement.
After intubation, the endotracheal tube was finally fixed after palpating endotracheal cuff at three sites (just below the cricoid cartilage, at suprasternal level and just below suprasternal notch). Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. This distance will be measured repeatedly, after pneumoperitoneum, after trendelenburg position and after making the patient supine at the end of surgery. Change in the distance will be noted.
Read the detailed description
The endotracheal tube (ETT) will be placed according to the black mark on the tube, post-intubation, the tube will be finally fixed after palpating endotracheal cuff at three sites (below cricoid cartilage, at suprasternal level and just below suprasternal notch). ETT cuff position will be scanned by sonography of airway to confirm the position of the proximal end of the ETT cuff. Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. This distance will be measured repeatedly 5 minutes after pneumoperitoneum, 10 minutes after trendelenburg position and 10 minutes after making the patient supine at the end of surgery. Change in the distance will be noted to confirm the migration of ETT.
- Conditions
- Robotic Surgical Procedures
- Being tested
- Three point cuff palpation technique
- Keywords
- Endotracheal intubation, pneumoperitoneum, trendelenburg position, Robotic surgery
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three point cuff palpation techniqueProcedure or surgery
Also called Black line mark on the endotracheal tube
the ETT is finally positioned according to the Three point cuff technique.
| Study group | Role | What they receive |
|---|---|---|
| Three point cuff palpation and Blck mark line technique | In "Three point cuff palpation technique" the cuff will be palpated just below the cricothyroid membrane,at the level of suprasternal notch and below the suprasternal notchand the tube is re-positioned in case of any discrepancy between the black mark line technique and three point cuff at three different over the trachea. Receives: Procedure: Three point cuff palpation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the distance between tip of endotracheal tube and Carina by fiber-optic bronchoscopy and measuring scale at various phases of robotic surgical procedure.
proper endotracheal tube placement is labelled when the distance between the tip of tube and Carina is more than 2.5 cm, after placement the tube by three point cuff palpation technique, its position will be assessed at respective time points.
Measured: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.pneumoperitoneum.
Secondary outcomes (1)
find the effect of cricod cartilage and supra-sternal distance on endotracheal tube tip to Carina distance.
cricoid cartilage to suprasternal distance changes with the position of neck, so it could affect the distance between the endotracheal tube tip and carina as the position of patient changes during various robotic surgical steps.
Measured: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Dec 2018
- Primary completion19 Jan 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Robotic Surgical ProceduresStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Kumar Mittal, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Amit Kr Mittal, MD, Principal investigator, Rajiv Gandhi Cancer Institute and Research centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440787
- Sponsor's protocol ID
- RES/SCM/30/2018/81
- Status last verified
- Jun 2020
- First submitted
- 15 Sep 2018
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang CH, Lee HK, Nam SH. The displacement of the tracheal tube during robot-assisted radical prostatectomy. Eur J Anaesthesiol. 2010 May;27(5):478-80. doi: 10.1097/EJA.0b013e328333d587.
PubMed 19918180
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate "Three Point Cuff Palpation Technique" for Assessing Optimal Depth of Endotracheal Tube Placement.
- ClinicalTrials.gov ID
- NCT04440787
- Acronym / sponsor ID
- RES/SCM/30/2018/81
- Conditions
- Robotic Surgical Procedures
- Keywords
- Endotracheal intubation, pneumoperitoneum, trendelenburg position, Robotic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 19 Jan 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 22 Jun 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 intubation, the endotracheal tube was finally fixed after palpating endotracheal cuff at three sites (just below the cricoid cartilage, at suprasternal level and just below suprasternal notch). Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. This distance will be measured repeatedly, after pneumoperitoneum, after trendelenburg position and after making the patient supine at the end of surgery. Change in the distance will be noted.
Detailed description
The endotracheal tube (ETT) will be placed according to the black mark on the tube, post-intubation, the tube will be finally fixed after palpating endotracheal cuff at three sites (below cricoid cartilage, at suprasternal level and just below suprasternal notch). ETT cuff position will be scanned by sonography of airway to confirm the position of the proximal end of the ETT cuff. Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. This distance will be measured repeatedly 5 minutes after pneumoperitoneum, 10 minutes after trendelenburg position and 10 minutes after making the patient supine at the end of surgery. Change in the distance will be noted to confirm the migration of ETT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three point cuff palpation and Blck mark line technique | – | Procedure: Three point cuff palpation techniqueIn "Three point cuff palpation technique" the cuff will be palpated just below the cricothyroid membrane,at the level of suprasternal notch and below the suprasternal notchand the tube is re-positioned in case of any discrepancy between the black mark line technique and three point cuff at three different over the trachea. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing the robotic urological or gynecological surgery in Trendelenburg position with pneumoperitoneum will be included in the study cohort.
Key inclusion criteria (2 listed)
- Robotic uro-oncological surgical procedures of perineum
- Robotic gynae-oncological surgical procedures of perineum
Key exclusion criteria (7 listed)
- Upper airway fibrosis or tracheal stenosis
- Large neck swelling distorting or deviating the trachea.
- Head and neck surgeries
- Laryngeal and tracheal tumour
- Tracheal surgery
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 |
|---|---|---|
| Three point cuff palpation techniqueAlso: Black line mark on the endotracheal tubethe ETT is finally positioned according to the Three point cuff technique. | Procedure or surgery | Three point cuff palpation and Blck mark line technique |
Primary outcome
Measure the distance between tip of endotracheal tube and Carina by fiber-optic bronchoscopy and measuring scale at various phases of robotic surgical procedure.
Time frame: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.pneumoperitoneum.
proper endotracheal tube placement is labelled when the distance between the tip of tube and Carina is more than 2.5 cm, after placement the tube by three point cuff palpation technique, its position will be assessed at respective time points.
1 secondary outcome
find the effect of cricod cartilage and supra-sternal distance on endotracheal tube tip to Carina distance.
Time frame: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Background: PubMed 19918180Chang CH, Lee HK, Nam SH. The displacement of the tracheal tube during robot-assisted radical prostatectomy. Eur J Anaesthesiol. 2010 May;27(5):478-80. doi: 10.1097/EJA.0b013e328333d587.
- Individual participant dataSharing planned: No
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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.
Amit Kr Mittal, MD principal investigator
Rajiv Gandhi Cancer Institute and Research centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Surgical Procedures, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit Kr Mittal, M.D (01147022323 ext. 2323, amitrgci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the distance between tip of endotracheal tube and Carina by fiber-optic bronchoscopy and measuring scale at various phases of robotic surgical procedure. (time frame: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.pneumoperitoneum.). 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 NCT04440787, which also lists 1 linked publication.
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 22 Jun 2020.