- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07590739
Effect Of Left Head Rotation On Glottic View During Video Laryngoscopy In Obese Adults (LeHeR)
Effect of Left Head Rotation Manoeuvre on Glottic View as Assessed With Percentage of Glottic Opening (POGO) Score During Video Laryngoscopy in Obese Adult Patients: A Prospective Observational Study
This study aims to evaluate whether the Left Head Rotation (LeHeR) maneuver improves visualization of the vocal cords during video laryngoscopy in obese adult patients undergoing general anesthesia. Obesity is associated with increased difficulty in airway management due to excess upper airway soft tissue and altered anatomy, which may impair visualization during intubation.
In this prospective observational study, 50 adult patients with a body mass index (BMI) ≥30 kg/m² will undergo video laryngoscopy using a C-MAC D-blade. The glottic view will be assessed using the Percentage of Glottic Opening (POGO) score in the standard sniffing position and after rotating the head 45 degrees to the left (LeHeR maneuver). A difference in POGO score between the two positions will be analyzed.
Secondary outcomes include ease of intubation, number of attempts, time to successful intubation, and occurrence of complications such as desaturation or airway trauma. The study is expected to determine whether the LeHeR maneuver is a simple and effective technique to improve airway visualization in obese patients.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Kalesh Divakar, MD
- Telefonnummer: +968 92452839
- E-Mail: drkalesh@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Harihar V Hegde, MD
- Telefonnummer: +968 98845606
- E-Mail: drharryhegde@yahoo.co.in
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria
- Adult patients aged 18-65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I-III
- Scheduled for elective surgical procedures under general anesthesia requiring endotracheal intubation
Exclusion Criteria:
- Anticipated need for nasal intubation
- Facial or upper airway pathology preventing laryngoscope insertion
- Cervical spine instability or contraindication to head movement
- Pregnant patients
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Percentage of Glottic Opening (POGO) Score between Sniffing Position and Left Head Rotation
Zeitfenster: Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
The Percentage of Glottic Opening (POGO) score will be assessed during video laryngoscopy in the sniffing position and after 45-degree left head rotation (LeHeR maneuver).
The difference in POGO score between the two positions will be recorded for each participant.
|
Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to Successful Intubation
Zeitfenster: During induction of anesthesia on Day 1
|
Time taken from insertion of the video laryngoscope blade into the oral cavity until successful placement of the endotracheal tube confirmed by capnography.
|
During induction of anesthesia on Day 1
|
|
Ease of Intubation
Zeitfenster: During tracheal intubation on Day 1
|
Ease of intubation assessed using Fremantle score as easy, modified, or unachievable based on number of attempts and need for adjuncts.
|
During tracheal intubation on Day 1
|
|
Number of Intubation Attempts
Zeitfenster: During tracheal intubation on Day 1
|
Number of attempts required to achieve successful tracheal intubation.
|
During tracheal intubation on Day 1
|
|
Requirement of Airway Adjuncts
Zeitfenster: During tracheal intubation on Day 1
|
Need for additional maneuvers such as external laryngeal manipulation, cuff inflation, or use of Magill forceps during intubation.
|
During tracheal intubation on Day 1
|
|
Incidence of Peri-intubation Complications
Zeitfenster: During induction of anesthesia and tracheal intubation on day 1
|
Occurrence of complications such as oxygen desaturation (SpO₂ <95%) or airway trauma during intubation.
|
During induction of anesthesia and tracheal intubation on day 1
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- MoH/CSR/26/31800
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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