Airway EdemaNCT05224895
The Effect of Trendelenburg Position on the Ultrasonographic Airway Measurements
An observational study of Airway Edema and Ultrasonography, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the changes in upper airway edema with the preoperative and postoperative ultrasonographic measurements of patients who undergo pobotic prostatectomy in the trendelenburg position. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Airway Edema, Ultrasonography, Robotic Surgical Procedures
- What is being tested?
- General Anesthesia in Trendelenburg position for robotic prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 30 Jul 2022
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: participants who undergo robotic prostatectomy in Ankara City Hospital
Who may be able to join
- Robotic Laparoscopic Prostatectomy
- ASA I-II-III-IV risk group -
Who cannot join
- contraindication of trendelenburg position,
- history of maxillofacial deformity, tumor or trauma,
- history of difficult airway,
- decompensated cardiac, respiratory, hepatic, renal disease,
- with cervical spine fracture
- patient refusal -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara, 06800
İsmail Aytac, +905056340369, aytacismail1972@gmail.com
About this study
Official title: Evaluation of the Effect of Trendelenburg Position on the Ultrasonographic Airway Measurements and Critical Respiratory Events
The aim of this study is to compare the changes in upper airway edema with the preoperative and postoperative ultrasonographic measurements of patients who undergo pobotic prostatectomy in the trendelenburg position.
The secondary aim is to investigate the correlation between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.
Read the detailed description
In the preoperative period, age, body weight, height, neck circumference, comorbidities (Charlson comorbidity index), ASA score, Modified mallampati classification, STOP-BANG risk score will be recorded.Intraoperative monitorization data will be recorded.
Following ultrasonographic airway measurements will be performed preoperatively and postoperatively.
A low frequency convex probe will be used for ultrasonography. To achieve a fixed position of the tongue, patients will be placed supine without a pillow, with their head fully tilted back, and asked to hold their tongue loosely, without phonation, with their mouth closed and tongue tips lightly touching the incisors. The probe will be placed under the chin in the median sagittal plane and adjusted to obtain a clear median sagittal tongue view.
Tongue thickness: When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness .
Median sagittal tongue cross-sectional area: The sagittal cross-sectional area of the tongue will then be measured by tracing the circumference of the tongue on the ultrasound machine.
Tongue width: The tongue width will then be obtained by measuring the distance between the probe placed transversely under the chin and the furthest points in the middle of the tongue in order to obtain as complete a tongue contour as possible.
Tongue volume: Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width, as described in previous studies .
Lateral parapharyngeal wall thickness: The lateral parapharyngeal wall thickness will be measured with a linear probe placed laterally into the cervical region in the direction of the external auditory canal to visualize the branching of the carotid artery. The lateral edge of the pharynx will be visualized as a hyperechoic line. Vibration artifacts and pharyngeal position will be confirmed by swallowing the patient. The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured .
Patients will be monitorized for critical respiratory events (CRE) postoperatively A PACU CRE is defined as, any unexpected hypoxemia (hemoglobin oxygen saturation < 90%), hypoventilation (respiratory rate < 8 bpm or arterial carbon dioxide tension > 50 mmHg), or upper airway obstruction (stridor or laryngospasm) will be considered as requiring active and specific intervention (ventilation, tracheal intubation, opioid or muscle relaxant antagonism, oral/nasal airway or airway manipulation).
- Upper airway obstruction requiring intervention (jaw thrust, oral airway);
- Mild to moderate hypoxemia (SpO2=93%-90%) that does not improve after active interventions in 3 L nasal cannula oxygen (increasing O2 flows to >3 L/min, high-flow surface application mask O2, verbal requests to breathe deeply, tactile stimulation);
- Severe hypoxemia (SpO2<90%) on 3 L nasal cannula O2, hypoxemia that does not improve after treatment (increased O2 flows >3 L/min, high-flow face mask O2 application, verbal requests deep breathing, tactile stimulation);
- Respiratory distress or signs of impending respiratory failure (respiratory rate >20/min, use of accessory muscles, tracheal tugging);
- Inability to take deep breaths when requested by the PACU nurse;
- The patient complains of symptoms of respiratory or upper airway muscle weakness (difficulty breathing, swallowing or speaking);
- Patient requiring reintubation in the PACU;
- Clinical evidence or suspected pulmonary aspiration after tracheal extubation (gastric contents and hypoxemia observed in the oropharynx)
- Conditions
- Airway Edema, Ultrasonography, Robotic Surgical Procedures, Postoperative Respiratory Complication
- Being tested
- General Anesthesia in Trendelenburg position for robotic prostatectomy
- Keywords
- Airway edema, ultrasonography, Robotic surgical procedures, Postoperative Respiratory Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anesthesia in Trendelenburg position for robotic prostatectomyProcedure or surgery
in this arm, changes in preoperative and postoperative airway measurements and correlation with postoperative critical airway events will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia in Trendelenburg position for robotic prostatectomy | Not described Receives: Procedure: General Anesthesia in Trendelenburg position for robotic prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Tongue thickness
When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness
Measured: Baseline, preoperative
postoperative Tongue thickness1
When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness
Measured: immediately postextubation
postoperative Tongue thickness2
When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness
Measured: postoperative 2. hour
preoperative Tongue volume
Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width
Measured: Baseline, preoperative
postoperative Tongue volume1
Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width
Measured: immediately postextubation
postoperativeTongue volume2
Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width
Measured: postoperative 2. hour
Preoperative Lateral parapharyngeal wall thickness
The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured
Measured: Baseline, preoperative
postoperative Lateral parapharyngeal wall thickness1
The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured
Measured: immediately postextubation
postoperative Lateral parapharyngeal wall thickness2
The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured
Measured: postoperative 2. hour
Number of participants with Critical respiratory events
A PACU critical respiratory event (CRE), any unexpected hypoxemia (hemoglobin oxygen saturation < 90%), hypoventilation (respiratory rate < 8 bpm or arterial carbon dioxide tension > 50 mmHg), or upper airway obstruction (stridor or laryngospasm) will be considered as requiring active and specific intervention (ventilation, tracheal intubation, opioid or muscle relaxant antagonism, oral/nasal airway or airway manipulation).
Measured: Within postoperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start15 Feb 2022
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway EdemaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
- Investigators
- betül güven aytaç, Principal investigator, ankara ch bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224895
- Sponsor's protocol ID
- E1-21-2231
- Status last verified
- Feb 2022
- First submitted
- 26 Dec 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Trendelenburg Position on the Ultrasonographic Airway Measurements and Critical Respiratory Events
- ClinicalTrials.gov ID
- NCT05224895
- Acronym / sponsor ID
- E1-21-2231
- Conditions
- Airway Edema, Ultrasonography, Robotic Surgical Procedures, Postoperative Respiratory Complication
- Keywords
- Airway edema, ultrasonography, Robotic surgical procedures, Postoperative Respiratory Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 4 Feb 2022 (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 aim of this study is to compare the changes in upper airway edema with the preoperative and postoperative ultrasonographic measurements of patients who undergo pobotic prostatectomy in the trendelenburg position.
The secondary aim is to investigate the correlation between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.
Detailed description
In the preoperative period, age, body weight, height, neck circumference, comorbidities (Charlson comorbidity index), ASA score, Modified mallampati classification, STOP-BANG risk score will be recorded.Intraoperative monitorization data will be recorded.
Following ultrasonographic airway measurements will be performed preoperatively and postoperatively.
A low frequency convex probe will be used for ultrasonography. To achieve a fixed position of the tongue, patients will be placed supine without a pillow, with their head fully tilted back, and asked to hold their tongue loosely, without phonation, with their mouth closed and tongue tips lightly touching the incisors. The probe will be placed under the chin in the median sagittal plane and adjusted to obtain a clear median sagittal tongue view.
Tongue thickness: When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness .
Median sagittal tongue cross-sectional area: The sagittal cross-sectional area of the tongue will then be measured by tracing the circumference of the tongue on the ultrasound machine.
Tongue width: The tongue width will then be obtained by measuring the distance between the probe placed transversely under the chin and the furthest points in the middle of the tongue in order to obtain as complete a tongue contour as possible.
Tongue volume: Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width, as described in previous studies .
Lateral parapharyngeal wall thickness: The lateral parapharyngeal wall thickness will be measured with a linear probe placed laterally into the cervical region in the direction of the external auditory canal to visualize the branching of the carotid artery. The lateral edge of the pharynx will be visualized as a hyperechoic line. Vibration artifacts and pharyngeal position will be confirmed by swallowing the patient. The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured .
Patients will be monitorized for critical respiratory events (CRE) postoperatively A PACU CRE is defined as, any unexpected hypoxemia (hemoglobin oxygen saturation < 90%), hypoventilation (respiratory rate < 8 bpm or arterial carbon dioxide tension > 50 mmHg), or upper airway obstruction (stridor or laryngospasm) will be considered as requiring active and specific intervention (ventilation, tracheal intubation, opioid or muscle relaxant antagonism, oral/nasal airway or airway manipulation).
- Upper airway obstruction requiring intervention (jaw thrust, oral airway);
- Mild to moderate hypoxemia (SpO2=93%-90%) that does not improve after active interventions in 3 L nasal cannula oxygen (increasing O2 flows to >3 L/min, high-flow surface application mask O2, verbal requests to breathe deeply, tactile stimulation);
- Severe hypoxemia (SpO2<90%) on 3 L nasal cannula O2, hypoxemia that does not improve after treatment (increased O2 flows >3 L/min, high-flow face mask O2 application, verbal requests deep breathing, tactile stimulation);
- Respiratory distress or signs of impending respiratory failure (respiratory rate >20/min, use of accessory muscles, tracheal tugging);
- Inability to take deep breaths when requested by the PACU nurse;
- The patient complains of symptoms of respiratory or upper airway muscle weakness (difficulty breathing, swallowing or speaking);
- Patient requiring reintubation in the PACU;
- Clinical evidence or suspected pulmonary aspiration after tracheal extubation (gastric contents and hypoxemia observed in the oropharynx)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia in Trendelenburg position for robotic prostatectomy | – | Procedure: General Anesthesia in Trendelenburg position for robotic prostatectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participants who undergo robotic prostatectomy in Ankara City Hospital
Key inclusion criteria (2 listed)
- Robotic Laparoscopic Prostatectomy
- ASA I-II-III-IV risk group -
Key exclusion criteria (6 listed)
- contraindication of trendelenburg position,
- history of maxillofacial deformity, tumor or trauma,
- history of difficult airway,
- decompensated cardiac, respiratory, hepatic, renal disease,
- with cervical spine fracture
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 |
|---|---|---|
| General Anesthesia in Trendelenburg position for robotic prostatectomyin this arm, changes in preoperative and postoperative airway measurements and correlation with postoperative critical airway events will be monitored. | Procedure or surgery | General Anesthesia in Trendelenburg position for robotic prostatectomy |
Primary outcome
Preoperative Tongue thickness
Time frame: Baseline, preoperative
When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness
postoperative Tongue thickness1
Time frame: immediately postextubation
When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness
postoperative Tongue thickness2
Time frame: postoperative 2. hour
When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness
preoperative Tongue volume
Time frame: Baseline, preoperative
Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width
postoperative Tongue volume1
Time frame: immediately postextubation
Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width
postoperativeTongue volume2
Time frame: postoperative 2. hour
Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width
Preoperative Lateral parapharyngeal wall thickness
Time frame: Baseline, preoperative
The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured
postoperative Lateral parapharyngeal wall thickness1
Time frame: immediately postextubation
The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured
postoperative Lateral parapharyngeal wall thickness2
Time frame: postoperative 2. hour
The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured
Number of participants with Critical respiratory events
Time frame: Within postoperative 2 hours
A PACU critical respiratory event (CRE), any unexpected hypoxemia (hemoglobin oxygen saturation < 90%), hypoventilation (respiratory rate < 8 bpm or arterial carbon dioxide tension > 50 mmHg), or upper airway obstruction (stridor or laryngospasm) will be considered as requiring active and specific intervention (ventilation, tracheal intubation, opioid or muscle relaxant antagonism, oral/nasal airway or airway manipulation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
betül güven aytaç principal investigator
ankara ch bilkent
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 Airway Edema and Ultrasonography, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 6 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 15 Feb 2022. 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 Turkey (Türkiye). 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 ismail aytac (+905056340369, aytacismail1972@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Tongue thickness (time frame: Baseline, preoperative). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2022.