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Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy

24 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

208

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: xiaoyong wei, Master's degree
  • Numer telefonu: 86-951-674-3252
  • E-mail: weixy9912@126.com

Lokalizacje studiów

    • Ningxia
      • Yinchuan, Ningxia, Chiny, 750001
        • General Hospital of Ningxia Medical University
        • Kontakt:
          • xiaoyong wei, Master's degree
          • Numer telefonu: 86-951-674-3252
          • E-mail: weixy9912@126.cm

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Inne nazwy:
  • left lateral 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.
Inne nazwy:
  • Left lateral position
Eksperymentalny: 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.
Inne nazwy:
  • left lateral 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 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.
Inne nazwy:
  • left lateral head elevation in a 30-degree position
Eksperymentalny: 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.
Inne nazwy:
  • Left lateral position
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.
Inne nazwy:
  • left lateral head elevation in a 30-degree position
Eksperymentalny: 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.
Inne nazwy:
  • left lateral head elevation in a 30-degree position
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.
Inne nazwy:
  • left lateral head elevation in a 30-degree position

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of hypoxemia
Ramy czasowe: During procedure
Incidence of SpO₂ ≤ 90% for >10 seconds during the examination.
During procedure

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Safe duration of pre-oxygenation
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: During procedure
Number of participants requiring manual jaw thrust to relieve airway obstruction during the examination.
During procedure
Requirement for nasal cannula oxygen
Ramy czasowe: During procedure
Number of participants requiring oxygen supplementation via nasal cannula during the examination.
During procedure
Requirement for increased oxygen flow
Ramy czasowe: During procedure
Number of participants requiring an increase in oxygen flow rate during the examination.
During procedure
Requirement for mask ventilation
Ramy czasowe: During procedure
Number of participants requiring bag-mask ventilation during the examination.
During procedure
Requirement for endotracheal intubation
Ramy czasowe: During procedure
Number of participants requiring endotracheal intubation during the examination.
During procedure
Incidence of airway intervention
Ramy czasowe: During procedure
Proportion of participants requiring any airway intervention (jaw thrust, nasal cannula, increased flow, mask ventilation, or intubation)
During procedure
Severity of coughing
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Safety outcome endpoints:heart rate
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Krzesło do nauki: Xinli Ni, Doctoral, General Hospital of Ningxia Medical University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

23 czerwca 2026

Zakończenie podstawowe (Szacowany)

31 lipca 2026

Ukończenie studiów (Szacowany)

31 sierpnia 2026

Daty rejestracji na studia

Pierwszy przesłany

15 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

29 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • dywe0003

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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