An observational study in Difficult Intubation, Laryngoscopy and Airway Management, sponsored by Sakarya University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Sakarya University · Observational
The left head rotation (LeHeR) maneuver, in which the head of the supine patient is rotated 45° to the left, is a simple, equipment-free technique proposed to improve laryngeal view during laryngoscopy. Published results are conflicting: self-controlled studies report improvement, whereas parallel-group and large cohort studies do not. This prospective, observational, self-controlled study aims to compare the glottic view obtained in the standard sniffing position with that obtained in the 45° LeHeR position in the same adult patients undergoing elective surgery under general anesthesia with direct laryngoscopy. Glottic view will be graded with the modified Cormack-Lehane classification and the Percentage of Glottic Opening (POGO) score. Intubation difficulty, need for additional maneuvers or adjuncts, hemodynamic changes, and airway trauma will also be recorded.
This single-center, prospective, observational, self-controlled study will be conducted in the operating rooms of the Çekmeköy State Hospital campus of Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants. No randomization, blinding, investigational drug, or device is involved; all anesthetic care follows institutional routine, in which the LeHeR maneuver is already used for patients with Cormack-Lehane grade 2-4 views.
Before induction, demographic data and airway assessment parameters (Mallampati score, retrognathia, thyromental distance, neck circumference, mouth opening, dentition, upper lip bite test, neck mobility) will be recorded. After induction and adequate neuromuscular blockade (3 minutes), direct laryngoscopy will be performed with an appropriately sized Macintosh blade in the sniffing position, and the best glottic view will be graded using the modified Cormack-Lehane (CL) scale and the POGO score. Patients with a CL grade 1 view will not be included in further analysis. In patients with CL grade 2A-4, the laryngoscope will be withdrawn, the head rotated 45° to the left while supine (LeHeR), and laryngoscopy repeated with CL and POGO grading. Intubation will be attempted in the LeHeR position; if unsuccessful, standard rescue maneuvers (BURP, external laryngeal manipulation, return to the sniffing position) and adjuncts (bougie/stylet) will be used and recorded.
CL grades will be compared with the Wilcoxon signed-rank test and categorical distributions with McNemar's test; POGO scores will be compared with the paired t-test or Wilcoxon signed-rank test as appropriate (p\<0.05). A sample of 119 patients provides ≥90% power to detect an effect size of Cohen's d ≥0.3 (two-sided α=0.05); allowing for 25% attrition, 150 patients will be enrolled.
Sakarya University is the lead sponsor of 190 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients aged 18-70 years with ASA physical status I-III who are scheduled for elective surgery under general anesthesia with oral endotracheal intubation in the operating rooms of Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital (Cekmekoy State Hospital campus), Istanbul, Turkiye. Consecutive eligible patients will be screened, and those with a modified Cormack-Lehane grade 2A-4 view on direct laryngoscopy in the sniffing position will be included in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients (18-70 years, ASA I-III) undergoing elective surgery under general anesthesia with direct laryngoscopy, in whom the initial glottic view in the sniffing position is modified Cormack-Lehane grade 2A-4. Each patient undergoes laryngoscopy first in the sniffing position and then with 45° left head rotation (LeHeR), serving as their own control.
Procedure: Direct laryngoscopy in the sniffing position · Procedure: Left Head Rotation (LeHeR) maneuver
After induction of general anesthesia and adequate neuromuscular blockade (3 minutes), direct laryngoscopy is performed with an appropriately sized Macintosh blade with the patient's head in the standard sniffing position. The best glottic view is graded using the modified Cormack-Lehane classification and the Percentage of Glottic Opening (POGO) score. Patients with a Cormack-Lehane grade 1 view are not studied further
In patients with a Cormack-Lehane grade 2A-4 view in the sniffing position, the laryngoscope is withdrawn, the patient's head is rotated 45° to the left while supine, and direct laryngoscopy is repeated with the same Macintosh blade. The glottic view is graded again using the modified Cormack-Lehane classification and the POGO score, and endotracheal intubation is attempted in this position. If unsuccessful, standard rescue maneuvers (BURP, external laryngeal manipulation, return to the sniffing position) and adjuncts (bougie/stylet) are used per routine practice.
Modified Cormack-Lehane Grade in the Sniffing Position Versus the LeHeR Position
Glottic view obtained during direct laryngoscopy with a Macintosh blade, graded using the modified Cormack-Lehane classification (1, 2A, 2B, 3A, 3B, 4; higher grades indicate a worse view). Each patient is assessed first in the sniffing position and then after 45° left head rotation (LeHeR), and the paired grades are compared within the same patient.
Time frame: During direct laryngoscopy, approximately 3-10 minutes after induction of general anesthesia
Percentage of Glottic Opening (POGO) Score in the Sniffing Position Versus the LeHeR Position
Percentage (0-100%) of the glottic opening visible from the anterior commissure to the interarytenoid notch during direct laryngoscopy; higher values indicate a better view. Each patient is assessed first in the sniffing position and then after 45° left head rotation (LeHeR), and the paired scores are compared within the same patient.
Time frame: During direct laryngoscopy, approximately 3-10 minutes after induction of general anesthesia
Intubation Difficulty Scale (IDS) Score
IDS score calculated as the sum of seven parameters (N1-N7): number of additional attempts, number of additional operators, number of alternative techniques, Cormack-Lehane grade minus 1 in the position in which intubation is achieved, increased lifting force (0/1), need for external laryngeal pressure (0/1), and vocal cord position (abducted 0 / adducted 1). Score 0 = easy intubation, 1-5 = slight difficulty, \>5 = moderate to major difficulty.
Time frame: During endotracheal intubation, from first laryngoscopy until confirmed tracheal intubation
Ease of Intubation
Ease of intubation categorized as: easy (successful at first attempt without additional maneuvers), moderate (successful at first attempt with additional maneuvers such as external laryngeal manipulation or stylet/bougie, or at second attempt), difficult (more than two attempts, a different operator or a different technique required, but ultimately successful), or impossible (fiberoptic/awake intubation required or failed intubation).
Time frame: During endotracheal intubation, from first laryngoscopy until confirmed tracheal intubation
Number of Participants Requiring Additional Airway Maneuvers
Number of participants requiring BURP (backward-upward-rightward pressure), external laryngeal manipulation, or return of the head to the sniffing position to achieve intubation after the LeHeR maneuver.
Time frame: During endotracheal intubation, from first laryngoscopy until confirmed tracheal intubation
Number of Participants Requiring a Bougie or Stylet
Number of participants in whom a gum elastic bougie or stylet is required to achieve endotracheal intubation.
Time frame: During endotracheal intubation, from first laryngoscopy until confirmed tracheal intubation
Intubation Time
Time in seconds from passage of the laryngoscope blade between the lips to the appearance of the first end-tidal carbon dioxide waveform on capnography.
Time frame: During endotracheal intubation, from first laryngoscopy until confirmed tracheal intubation
Number of Participants With Airway Trauma
Number of participants with signs of airway trauma, defined as blood on the laryngoscope blade or endotracheal tube, or lip, dental or oropharyngeal mucosal injury.
Time frame: From first laryngoscopy until 5 minutes after intubation
Heart Rate
Heart rate (beats/min) recorded at predefined time points to assess hemodynamic and oxygenation changes associated with laryngoscopy and intubation.
Time frame: Baseline (before induction), after induction, and at 1, 3, 5 and 10 minutes after intubation
Mean Arterial Pressure
Mean arterial pressure (mmHg) recorded at predefined time points to assess hemodynamic and oxygenation changes associated with laryngoscopy and intubation.
Time frame: Baseline (before induction), after induction, and at 1, 3, 5 and 10 minutes after intubation
Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO2, %) recorded at predefined time points to assess hemodynamic and oxygenation changes associated with laryngoscopy and intubation.
Time frame: Baseline (before induction), after induction, and at 1, 3, 5 and 10 minutes after intubation
No study locations are listed for this record.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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