Adult Patient Undergoing Elective Surgery With General Anesthesia and Needs Nasogastric Tube PlacementNCT03134287
Nasogastric Tube Placement on Intubated Patient: Two-Finger Method vs Reverse Sellick's Maneuver
A study testing two-finger method, reverse sellick's method in people with Adult Patient Undergoing Elective Surgery With General Anesthesia and Needs Nasogastric Tube Placement, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The study aimed to compare the efficacy between nasogastric tube placement using Two-Finger Method and Reverse Sellick's Maneuver Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Patient Undergoing Elective Surgery With General Anesthesia and Needs Nasogastric Tube Placement
- What is being tested?
- two-finger method, reverse sellick's method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2017to 31 May 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients aged 18-60 years old, with American Society of Anesthesiologists (ASA) physical status of I-III who were planned to undergo any elective surgery at operating room in general anesthesia and needed nasogastric tube placement
- subjects had been explained about the study, and agreed to enroll and have signed the informed consent form
Who cannot join
- Subjects with possibility of difficult airway
- multiple fracture in the head
- craniofacial, airway, esophagus, and neck abnormality
- Drop out Criteria:
- Subjects who experience airway trauma during intubation or allergic reaction due to drugs used
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Feasibility of Nasogastric Tube Placement on Intubated Patient: Comparison Between Two-Finger Method and Reverse Sellick's Maneuver
The study aimed to compare the efficacy between nasogastric tube placement using Two-Finger Method and Reverse Sellick's Maneuver
Read the detailed description
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Two-Finger method group and Reverse Sellick's maneuver group). Intravenous (IV) cannula with isotonic fluid, non-invasive blood pressure monitor, and pulse-oxymetry were set on the subjects in the operation room. Vital signs were recorded. Midazolam 1-2 mg and Fentanyl 2 µg/kg body weight (BW) were given as premedication. Induction was performed using propofol 2-3 µg/kg BW. Rocuronium 0.5mg/kg BW was also given after induction. Two minimum alveolar concentration (MAC) of sevoflurane and 6 liter per minute of oxygen were also given using face mask for 3 minutes until the drugs took effect. Patient were then intubated. Evaluation of airway was performed to exclude the subjects who experienced airway trauma. Estimating the length of nasogastric tube was performed by stretching the nasogastric tube from xyphoid process through nose to the back of the ear. The measured number in cm then added with 15 cm and marked with tape. Nasogastric tube and the selected nostril then covered in gel sufficiently. The Two-Finger method group was placed with nasogastric tube using two-finger method, before the procedure, the endotracheal tube cuff was deflated first. And then the nasogastric tube was inserted into the selected nostril perpendicularly using dominant hand. The non-dominant hand (index and middle finger) was inserted to the base of oropharynx until the nasogastric tube was felt , and the the nasogastric tube was fixated in the middle position and the base of pharynx, as nearest as possible from esophagus, while the dominant hand pushed the nasogastric tube until it reached the mark. The reverse Sellick's maneuver group's endotracheal tube was also deflated before the procedure. The nasogastric tube was inserted into the selected nostril perpendicularly using dominant hand and pushed gently until it reached the first resistance in nasopharynx. Reverse Sellick's maneuver was performed using non-dominant hand, done by grabbing thyroid cartilage upward and elevated the larynx anteriorly, while the dominant hand kept pushing the nasogastric tube gently until it reached the mark. Evaluation whether or not the nasogastric tube was properly placed was using the auscultation method in the epigastric region and inserting air through catheter tip. Time and complications occurred during procedure were recorded. And the nasogastric tube was fixated if it was successfully inserted.
- Being tested
- two-finger method, reverse sellick's method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-finger method, reverse sellick's methodProcedure or surgery
Subjects received nasogastric tube placement by two-finger method; Subjects received nasogastric tube placement by reverse sellick's method
| Study group | Role | What they receive |
|---|---|---|
| two-finger method | Active comparator | Those who received nasogastric tube placement by two-finger method Receives: Procedure: two-finger method, reverse sellick's method |
| reverse sellick's method | Active comparator | Those who received nasogastric tube placement by reverse sellick's method Receives: Procedure: two-finger method, reverse sellick's method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful rate
Successful rate on nasogastric tube placement in first attempt
Measured: Day 1
Secondary outcomes (2)
Time
Time needed to insert the nasogastric tube
Measured: Day 1
Complications
Complications occurred during procedure
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Feb 2017
- Primary completion1 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Adult Patient Undergoing Elective Surgery With General Anesthesia and Needs Nasogastric Tube PlacementStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Aida Rosita Tantri SpAn-KA, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134287
- Sponsor's protocol ID
- IndonesiaUAnes013
- Status last verified
- Aug 2017
- First submitted
- 26 Apr 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sinha PK, Koshy T. Reverse Sellick's maneuver for transesophageal echocardiographic probe placement. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):626-8. doi: 10.1053/j.jvca.2006.10.010. Epub 2007 Jan 9. No abstract available.
PubMed 17678806Ratzlaff HC, Heaslip JE, Rothwell ES. Factors affecting nasogastric tube insertion. Crit Care Med. 1984 Jan;12(1):52-3. doi: 10.1097/00003246-198401000-00014.
PubMed 6690206Ozer S, Benumof JL. Oro- and nasogastric tube passage in intubated patients: fiberoptic description of where they go at the laryngeal level and how to make them enter the esophagus. Anesthesiology. 1999 Jul;91(1):137-43. doi: 10.1097/00000542-199907000-00022.
PubMed 10422939Kirtania J, Ghose T, Garai D, Ray S. Esophageal guidewire-assisted nasogastric tube insertion in anesthetized and intubated patients: a prospective randomized controlled study. Anesth Analg. 2012 Feb;114(2):343-8. doi: 10.1213/ANE.0b013e31823be0a4. Epub 2011 Nov 21.
PubMed 22104075Agarwal A, Gaur A, Sahu D, Singh PK, Pandey CK. Nasogastric tube knotting over the epiglottis: a cause of respiratory distress. Anesth Analg. 2002 Jun;94(6):1659-60, table of contents. doi: 10.1097/00000539-200206000-00056.
PubMed 12032048Cataldi-Betcher EL, Seltzer MH, Slocum BA, Jones KW. Complications occurring during enteral nutrition support: a prospective study. JPEN J Parenter Enteral Nutr. 1983 Nov-Dec;7(6):546-52. doi: 10.1177/0148607183007006546.
PubMed 6418910Noguchi T, Shiga Y, Koga K, Shigematsu A. A method to improve a gas leak on mask ventilation in the patient with a nasogastric tube. Anesthesiology. 2001 Mar;94(3):545. doi: 10.1097/00000542-200103000-00041. No abstract available.
PubMed 11374627Appukutty J, Shroff PP. Nasogastric tube insertion using different techniques in anesthetized patients: a prospective, randomized study. Anesth Analg. 2009 Sep;109(3):832-5. doi: 10.1213/ane.0b013e3181af5e1f.
PubMed 19690254Mahajan R, Gupta R, Sharma A. Role of neck flexion in facilitating nasogastric tube insertion. Anesthesiology. 2005 Aug;103(2):446-7. doi: 10.1097/00000542-200508000-00034. No abstract available.
PubMed 16052133Chun DH, Kim NY, Shin YS, Kim SH. A randomized, clinical trial of frozen versus standard nasogastric tube placement. World J Surg. 2009 Sep;33(9):1789-92. doi: 10.1007/s00268-009-0144-x.
PubMed 19626360Moharari RS, Fallah AH, Khajavi MR, Khashayar P, Lakeh MM, Najafi A. The GlideScope facilitates nasogastric tube insertion: a randomized clinical trial. Anesth Analg. 2010 Jan 1;110(1):115-8. doi: 10.1213/ANE.0b013e3181be0e43. Epub 2009 Oct 27.
PubMed 19861362Perel A, Ya'ari Y, Pizov R. Forward displacement of the larynx for nasogastric tube insertion in intubated patients. Crit Care Med. 1985 Mar;13(3):204-5. doi: 10.1097/00003246-198503000-00013.
PubMed 3971730
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Nasogastric Tube Placement on Intubated Patient: Comparison Between Two-Finger Method and Reverse Sellick's Maneuver
- ClinicalTrials.gov ID
- NCT03134287
- Acronym / sponsor ID
- IndonesiaUAnes013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 28 Apr 2017 (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.
The study aimed to compare the efficacy between nasogastric tube placement using Two-Finger Method and Reverse Sellick's Maneuver
Detailed description
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Two-Finger method group and Reverse Sellick's maneuver group). Intravenous (IV) cannula with isotonic fluid, non-invasive blood pressure monitor, and pulse-oxymetry were set on the subjects in the operation room. Vital signs were recorded. Midazolam 1-2 mg and Fentanyl 2 µg/kg body weight (BW) were given as premedication. Induction was performed using propofol 2-3 µg/kg BW. Rocuronium 0.5mg/kg BW was also given after induction. Two minimum alveolar concentration (MAC) of sevoflurane and 6 liter per minute of oxygen were also given using face mask for 3 minutes until the drugs took effect. Patient were then intubated. Evaluation of airway was performed to exclude the subjects who experienced airway trauma. Estimating the length of nasogastric tube was performed by stretching the nasogastric tube from xyphoid process through nose to the back of the ear. The measured number in cm then added with 15 cm and marked with tape. Nasogastric tube and the selected nostril then covered in gel sufficiently. The Two-Finger method group was placed with nasogastric tube using two-finger method, before the procedure, the endotracheal tube cuff was deflated first. And then the nasogastric tube was inserted into the selected nostril perpendicularly using dominant hand. The non-dominant hand (index and middle finger) was inserted to the base of oropharynx until the nasogastric tube was felt , and the the nasogastric tube was fixated in the middle position and the base of pharynx, as nearest as possible from esophagus, while the dominant hand pushed the nasogastric tube until it reached the mark. The reverse Sellick's maneuver group's endotracheal tube was also deflated before the procedure. The nasogastric tube was inserted into the selected nostril perpendicularly using dominant hand and pushed gently until it reached the first resistance in nasopharynx. Reverse Sellick's maneuver was performed using non-dominant hand, done by grabbing thyroid cartilage upward and elevated the larynx anteriorly, while the dominant hand kept pushing the nasogastric tube gently until it reached the mark. Evaluation whether or not the nasogastric tube was properly placed was using the auscultation method in the epigastric region and inserting air through catheter tip. Time and complications occurred during procedure were recorded. And the nasogastric tube was fixated if it was successfully inserted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two-finger method | Active comparator | Procedure: two-finger method, reverse sellick's methodThose who received nasogastric tube placement by two-finger method |
| reverse sellick's method | Active comparator | Procedure: two-finger method, reverse sellick's methodThose who received nasogastric tube placement by reverse sellick's method |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18-60 years old, with American Society of Anesthesiologists (ASA) physical status of I-III who were planned to undergo any elective surgery at operating room in general anesthesia and needed nasogastric tube placement
- subjects had been explained about the study, and agreed to enroll and have signed the informed consent form
Key exclusion criteria (5 listed)
- Subjects with possibility of difficult airway
- multiple fracture in the head
- craniofacial, airway, esophagus, and neck abnormality
- Subjects who experience airway trauma during intubation or allergic reaction due to drugs used
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 |
|---|---|---|
| two-finger method, reverse sellick's methodSubjects received nasogastric tube placement by two-finger method; Subjects received nasogastric tube placement by reverse sellick's method | Procedure or surgery | reverse sellick's method, two-finger method |
Primary outcome
Successful rate
Time frame: Day 1
Successful rate on nasogastric tube placement in first attempt
2 secondary outcomes
Time
Time frame: Day 1
Complications
Time frame: Day 1
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 18 Aug 2017.
- Background: PubMed 17678806Sinha PK, Koshy T. Reverse Sellick's maneuver for transesophageal echocardiographic probe placement. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):626-8. doi: 10.1053/j.jvca.2006.10.010. Epub 2007 Jan 9. No abstract available.
- Background: PubMed 6690206Ratzlaff HC, Heaslip JE, Rothwell ES. Factors affecting nasogastric tube insertion. Crit Care Med. 1984 Jan;12(1):52-3. doi: 10.1097/00003246-198401000-00014.
- Background: PubMed 10422939Ozer S, Benumof JL. Oro- and nasogastric tube passage in intubated patients: fiberoptic description of where they go at the laryngeal level and how to make them enter the esophagus. Anesthesiology. 1999 Jul;91(1):137-43. doi: 10.1097/00000542-199907000-00022.
- Background: PubMed 22104075Kirtania J, Ghose T, Garai D, Ray S. Esophageal guidewire-assisted nasogastric tube insertion in anesthetized and intubated patients: a prospective randomized controlled study. Anesth Analg. 2012 Feb;114(2):343-8. doi: 10.1213/ANE.0b013e31823be0a4. Epub 2011 Nov 21.
- Background: PubMed 12032048Agarwal A, Gaur A, Sahu D, Singh PK, Pandey CK. Nasogastric tube knotting over the epiglottis: a cause of respiratory distress. Anesth Analg. 2002 Jun;94(6):1659-60, table of contents. doi: 10.1097/00000539-200206000-00056.
- Background: PubMed 6418910Cataldi-Betcher EL, Seltzer MH, Slocum BA, Jones KW. Complications occurring during enteral nutrition support: a prospective study. JPEN J Parenter Enteral Nutr. 1983 Nov-Dec;7(6):546-52. doi: 10.1177/0148607183007006546.
- Background: PubMed 11374627Noguchi T, Shiga Y, Koga K, Shigematsu A. A method to improve a gas leak on mask ventilation in the patient with a nasogastric tube. Anesthesiology. 2001 Mar;94(3):545. doi: 10.1097/00000542-200103000-00041. No abstract available.
- Background: PubMed 19690254Appukutty J, Shroff PP. Nasogastric tube insertion using different techniques in anesthetized patients: a prospective, randomized study. Anesth Analg. 2009 Sep;109(3):832-5. doi: 10.1213/ane.0b013e3181af5e1f.
- Background: PubMed 16052133Mahajan R, Gupta R, Sharma A. Role of neck flexion in facilitating nasogastric tube insertion. Anesthesiology. 2005 Aug;103(2):446-7. doi: 10.1097/00000542-200508000-00034. No abstract available.
- Background: PubMed 19626360Chun DH, Kim NY, Shin YS, Kim SH. A randomized, clinical trial of frozen versus standard nasogastric tube placement. World J Surg. 2009 Sep;33(9):1789-92. doi: 10.1007/s00268-009-0144-x.
- Background: PubMed 19861362Moharari RS, Fallah AH, Khajavi MR, Khashayar P, Lakeh MM, Najafi A. The GlideScope facilitates nasogastric tube insertion: a randomized clinical trial. Anesth Analg. 2010 Jan 1;110(1):115-8. doi: 10.1213/ANE.0b013e3181be0e43. Epub 2009 Oct 27.
- Background: PubMed 3971730Perel A, Ya'ari Y, Pizov R. Forward displacement of the larynx for nasogastric tube insertion in intubated patients. Crit Care Med. 1985 Mar;13(3):204-5. doi: 10.1097/00003246-198503000-00013.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two-finger method, reverse sellick's method in people with Adult Patient Undergoing Elective Surgery With General Anesthesia and Needs Nasogastric Tube Placement, run by Universitas Indonesia at 1 site in Indonesia.
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 5 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 18 Aug 2017. 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 Indonesia. 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?
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?
Successful rate (time frame: Day 1). 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 NCT03134287, which also lists 12 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 18 Aug 2017.