Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy
24. června 2026 aktualizováno: General Hospital of Ningxia Medical University
Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy: A 2×2 Factorial Randomized Controlled Trial
To investigate the independent effects and interaction of pre-oxygenation position (left lateral vs left lateral with 30° head-up tilt) and examination position (left lateral vs left lateral with 30° head-up tilt) on hypoxemia during painless gastroscopy and colonoscopy using a 2×2 factorial design.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
Painless gastroscopy and colonoscopy represent core minimally invasive techniques for colorectal cancer screening and the diagnosis and treatment of gastrointestinal diseases. By utilizing intravenous sedation to ensure a pain-free experience, these procedures are widely adopted in clinical practice. However, perioperative hypoxemia remains the most common and critical safety complication during sedation for endoscopy. It is primarily caused by anesthesia-induced respiratory depression, tongue base collapse, airway obstruction, diaphragmatic compression, and restricted thoracic movement, with significantly elevated risks observed in obese, elderly, snoring, and short-necked patients.
Hypoxemia may trigger bradycardia, arrhythmias, myocardial ischemia, and cerebral hypoxia. In severe cases, it can lead to apnea, laryngospasm, and forced termination of the procedure, making it a key indicator in endoscopic anesthesia quality control.
Pre-oxygenation is a fundamental measure to increase functional residual capacity (FRC) and prolong the safe apneic time prior to induction, thereby preventing hypoxemia. The examination position directly determines airway patency, mandibular relaxation, diaphragmatic position, and thoracic compliance throughout the procedure. Both are critical, controllable factors regulating perioperative oxygenation. Studies have confirmed that the left lateral position reduces the incidence of hypoxemia, while the left lateral position with 30° head elevation effectively relaxes the mandible, alleviates tongue base collapse, reduces abdominal organ pressure on the diaphragm, and improves ventilation and oxygenation by increasing FRC.
Current research largely focuses on either the pre-oxygenation position or the examination position in isolation, presenting notable limitations: first, the interaction between these two positions has not been evaluated, leaving the synergistic or antagonistic effects of combined interventions unclear; second, there is a lack of efficient validation using a factorial design, which is necessary to simultaneously analyze the main effects and interactions of both independent variables.
Addressing these clinical challenges and research gaps, this study employs a 2×2 factorial randomized controlled design. With pre-oxygenation position and examination position serving as the two intervention factors, the study aims to explore the individual and combined effects of both factors on perioperative hypoxemia. The objective is to identify the optimal positional combination, establish standardized and generalizable positioning protocols for painless endoscopy, accurately reduce the incidence of hypoxemia, enhance the precision of anesthesia management, and provide high-level evidence to guide clinical practice.
Typ studie
Intervenční
Zápis (Odhadovaný)
208
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: xiaoyong wei, Master's degree
- Telefonní číslo: 86-951-674-3252
- E-mail: weixy9912@126.com
Studijní místa
-
-
Ningxia
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Yinchuan, Ningxia, Čína, 750001
- General Hospital of Ningxia Medical University
-
Kontakt:
- xiaoyong wei, Master's degree
- Telefonní číslo: 86-951-674-3252
- E-mail: weixy9912@126.cm
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Aged 18 to 75 years, regardless of gender
- Body mass index (BMI): 18.5 - 35 kg/m²
- ASA physical status class I, II or III
- Scheduled for painless gastroscopy, painless colonoscopy, or combined painless gastroenteroscopy
- Able to understand the study procedure and provide written informed consent
Exclusion Criteria:
- Severe cardiopulmonary diseases, including severe COPD, heart failure, severe arrhythmia and pulmonary hypertension
- Difficult airway identified before anesthesia
- Severe obstructive sleep apnea (OSA)
- Spinal or thoracic deformity
- Preoperative baseline hypoxemia
- Known allergy to any anesthetic drugs used in this study
- Pregnant females
- Unable to cooperate with required intraoperative body position
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Group A1B1 (traditional conventional group)
Pre-oxygenated left lateral position + examination in left lateral position
|
An angle measuring device is placed beside the head of the examination bed to enable precise adjustment of the head position.
Pre-oxygenation phase: Administer pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; instruct the patient to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout.
If the position is altered during this phase, discontinue the procedure.
Left lateral pre-oxygenation: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 0°, supported by pillows to maintain a neutral spine position and avoid excessive neck extension or flexion.
Ostatní jména:
Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase.
If the position is altered midway through the examination, the patient will be excluded from the study.
Left lateral position examination: The patient assumes a 90-degree left lateral position on a horizontal bed surface with the head of the bed elevated to 0°, supported by pillows to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.
Ostatní jména:
|
|
Experimentální: Group A1B2 (improved examination group)
Left lateral position with pre-oxygenation + left head elevated 30° during examination
|
An angle measuring device is placed beside the head of the examination bed to enable precise adjustment of the head position.
Pre-oxygenation phase: Administer pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; instruct the patient to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout.
If the position is altered during this phase, discontinue the procedure.
Left lateral pre-oxygenation: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 0°, supported by pillows to maintain a neutral spine position and avoid excessive neck extension or flexion.
Ostatní jména:
Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase.
If the position is altered midway through the examination, the patient will be excluded from the study.
Left lateral decubitus examination: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 30°, supported by a pillow to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.
Ostatní jména:
|
|
Experimentální: Group A2B1 (pre-oxygenation improvement group)
Left-sided head position at 30°, pre-oxygenated air administration + examination in left lateral decubitus position
|
Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase.
If the position is altered midway through the examination, the patient will be excluded from the study.
Left lateral position examination: The patient assumes a 90-degree left lateral position on a horizontal bed surface with the head of the bed elevated to 0°, supported by pillows to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.
Ostatní jména:
An angle measuring device is placed beside the head of the examination bed to allow precise adjustment of the head position.
Pre-oxygenation phase: The patient receives pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; they are instructed to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout.
If the position is altered during this phase, the procedure is discontinued.
Left-sided head elevation (30°): During pre-oxygenation, the patient lies in a left lateral position on a horizontal bed surface with the head elevated by 30°, supported by pillows to maintain a neutral spinal alignment and prevent excessive neck extension or flexion.
Ostatní jména:
|
|
Experimentální: Group A2B2 (double-position improvement group)
Left-sided head height at 30 weeks: pre-oxygenated condition + left-sided head height at 30 weeks examination
|
Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase.
If the position is altered midway through the examination, the patient will be excluded from the study.
Left lateral decubitus examination: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 30°, supported by a pillow to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.
Ostatní jména:
An angle measuring device is placed beside the head of the examination bed to allow precise adjustment of the head position.
Pre-oxygenation phase: The patient receives pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; they are instructed to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout.
If the position is altered during this phase, the procedure is discontinued.
Left-sided head elevation (30°): During pre-oxygenation, the patient lies in a left lateral position on a horizontal bed surface with the head elevated by 30°, supported by pillows to maintain a neutral spinal alignment and prevent excessive neck extension or flexion.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of hypoxemia
Časové okno: During procedure
|
Incidence of SpO₂ ≤ 90% for >10 seconds during the examination.
|
During procedure
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Safe duration of pre-oxygenation
Časové okno: During procedure
|
Time from cessation of oxygen administration (start of anesthesia induction) to first SpO₂ <92% for ≥3 seconds.
If no desaturation occurs, the value equals the duration from oxygen cessation to end of procedure (right-censored).
|
During procedure
|
|
Incidence of subclinical respiratory depression
Časové okno: During procedure
|
Defined as the proportion of participants experiencing SpO₂ between 90% and 95% (inclusive) at any time during the examination.
|
During procedure
|
|
Requirement for jaw thrust
Časové okno: During procedure
|
Number of participants requiring manual jaw thrust to relieve airway obstruction during the examination.
|
During procedure
|
|
Requirement for nasal cannula oxygen
Časové okno: During procedure
|
Number of participants requiring oxygen supplementation via nasal cannula during the examination.
|
During procedure
|
|
Requirement for increased oxygen flow
Časové okno: During procedure
|
Number of participants requiring an increase in oxygen flow rate during the examination.
|
During procedure
|
|
Requirement for mask ventilation
Časové okno: During procedure
|
Number of participants requiring bag-mask ventilation during the examination.
|
During procedure
|
|
Requirement for endotracheal intubation
Časové okno: During procedure
|
Number of participants requiring endotracheal intubation during the examination.
|
During procedure
|
|
Incidence of airway intervention
Časové okno: During procedure
|
Proportion of participants requiring any airway intervention (jaw thrust, nasal cannula, increased flow, mask ventilation, or intubation)
|
During procedure
|
|
Severity of coughing
Časové okno: During procedure
|
Assessed using a 4-grade scale: Grade I (none), Grade II (single mild episode), Grade III (multiple episodes <15s), Grade IV (continuous >15s)
|
During procedure
|
|
Length of stay in recovery room
Časové okno: Up to 30 minutes post-anesthesia care unit (PACU) admission
|
Time from arrival to discharge from the recovery room (maximum observation 30 minutes)
|
Up to 30 minutes post-anesthesia care unit (PACU) admission
|
|
Endoscopist satisfaction score
Časové okno: During procedure
|
Assessed using a Numerical Rating Scale (NRS) ranging from 0 to 10, with higher scores indicating greater satisfaction.
|
During procedure
|
|
Incidence of postoperative nausea, vomiting, headache, and dizziness
Časové okno: Up to 30 minutes post-anesthesia care unit (PACU) admission
|
Proportion of participants experiencing nausea, vomiting, headache, or dizziness after awakening in the recovery room.
|
Up to 30 minutes post-anesthesia care unit (PACU) admission
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Safety outcome endpoints：heart rate
Časové okno: Baseline and during procedure
|
Recorded at T0 (before pre-oxygenation), T1 (before induction), T2 (scope insertion), and T3 (scope removal).
|
Baseline and during procedure
|
|
Safety outcome endpoints：blood pressure
Časové okno: Baseline and during procedure
|
Recorded at T0 (before pre-oxygenation), T1 (before induction), T2 (scope insertion), and T3 (scope removal)
|
Baseline and during procedure
|
|
Safety outcome endpoints：peripheral oxygen saturation (SpO₂)
Časové okno: Baseline and during procedure
|
Recorded at T0 (before pre-oxygenation), T1 (before induction), T2 (scope insertion), and T3 (scope removal).
|
Baseline and during procedure
|
|
Safety outcome endpoints：Incidence of hemodynamic instability in recovery
Časové okno: Up to 30 minutes post-anesthesia care unit (PACU) admission
|
Occurrence of tachycardia (>100 bpm), bradycardia (<50 bpm), or hypotension (systolic blood pressure <80 mmHg) during the recovery period.
|
Up to 30 minutes post-anesthesia care unit (PACU) admission
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Studijní židle: Xinli Ni, Doctoral, General Hospital of Ningxia Medical University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
23. června 2026
Primární dokončení (Odhadovaný)
31. července 2026
Dokončení studie (Odhadovaný)
31. srpna 2026
Termíny zápisu do studia
První předloženo
15. června 2026
První předloženo, které splnilo kritéria kontroly kvality
24. června 2026
První zveřejněno (Aktuální)
29. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. června 2026
Naposledy ověřeno
1. června 2026
Více informací
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