Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment

NCT06085859 | Unknown DMC

• 1 other identifier: endoscope mask-1
• Study Type: interventional
• Target: 1,208
• Locations: 1 country
• Sites: 5

Brief Summary

To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy

Conditions

Hypoxemia

Keywords

hypoxemia; sedation; gastrointestinal sedation procedure; non-invasive ventilation; endoscopy mask

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxemia

  Incidences of oxygen saturation falling below 92%

  From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.

Secondary Outcomes (11)

• Incidence of compromised ventilation mandating primary manual intervention

  From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.

• Incidence necessitating sophisticated manual ventilatory support during pain-free gastroscopy

  From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.

• Juxtaposition of hypoxemia onset time in both ventilation techniques

  From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.

• the temporal span from initial decline to recovery to 92% saturation in both ventilation techniques

  From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.

• the lowest oxygen saturation in both ventilation techniques

  From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.

Study Arms (2)

Mask oxygen supply group

EXPERIMENTAL

The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter

Device: Mask group

Nasal oxygen supply group

EXPERIMENTAL

The study team applied the mask with a head strap to ensure a proper seal,simultaneously ensuring the same oxygen flow rate as the control group

Device: Routine nasal catheter group

Interventions

Routine nasal catheter group DEVICE

The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter as described in the guide

Nasal oxygen supply group

Mask group DEVICE

The study team applied the mask with a head strap to ensure a proper seal,simultaneously ensuring the same oxygen flow rate as the control group

Mask oxygen supply group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Upcoming upper gastrointestinal sedation procedure;
• Classification under the American Association of Anesthesiologists (ASA) status I-III;
• Baseline oxygen saturation (SpO2) ≥95% in ambient air conditions.

You may not qualify if:

• Individuals with previously documented difficulties in mask ventilation (DMV);
• Patients predisposed to aspiration risks or episodes of vomiting;
• Facial or jaw injuries or congenital abnormalities that render conventional face mask application infeasible;
• An inability or unwillingness to utilize the novel disposable anesthesia face mask.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead
• Anhui Sanhong Medical Device Technology Co., Ltd: collaborator

Study Sites (5)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

First People's Hospital of Liangshan Yi Autonomous Prefecture

Liangshan, Sichuan, China

RECRUITING

Second People's Hospital of Yibin

Yibin, Sichuan, China

RECRUITING

Ziyang People's Hospital

Ziyang, Sichuan, China

RECRUITING

Chengdu Second People's Hospital

Sichuan, China

RECRUITING

Related Publications (8)

• Behrens A, Kreuzmayr A, Manner H, Koop H, Lorenz A, Schaefer C, Plauth M, Jetschmann JU, von Tirpitz C, Ewald M, Sackmann M, Renner W, Kruger M, Schwab D, Hoffmann W, Engelke O, Pech O, Kullmann F, Pampuch S, Lenfers B, Weickert U, Schilling D, Boehm S, Beckebaum S, Cicinnati V, Erckenbrecht JF, Dumoulin FL, Benz C, Rabenstein T, Haltern G, Balsliemke M, de Mas C, Kleber G, Pehl C, Vogt C, Kiesslich R, Fischbach W, Koop I, Kuehne J, Breidert M, Sass NL, May A, Friedrich C, Veitt R, Porschen R, Ellrichmann M, Arlt A, Schmitt W, Dollhopf M, Schmidbaur W, Dignass A, Schmitz V, Labenz J, Kaiser G, Krannich A, Barteska N, Ell C. Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications. Gut. 2019 Mar;68(3):445-452. doi: 10.1136/gutjnl-2015-311037. Epub 2018 Jan 3.

  PMID: 29298872 BACKGROUND

• Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.

  PMID: 33933271 BACKGROUND

• Goudra B, Nuzat A, Singh PM, Borle A, Carlin A, Gouda G. Association between Type of Sedation and the Adverse Events Associated with Gastrointestinal Endoscopy: An Analysis of 5 Years' Data from a Tertiary Center in the USA. Clin Endosc. 2017 Mar;50(2):161-169. doi: 10.5946/ce.2016.019. Epub 2016 Apr 29.

  PMID: 27126387 BACKGROUND

• Qin Y, Li LZ, Zhang XQ, Wei Y, Wang YL, Wei HF, Wang XR, Yu WF, Su DS. Supraglottic jet oxygenation and ventilation enhances oxygenation during upper gastrointestinal endoscopy in patients sedated with propofol: a randomized multicentre clinical trial. Br J Anaesth. 2017 Jul 1;119(1):158-166. doi: 10.1093/bja/aex091.

  PMID: 28974061 BACKGROUND

• Bell GD, Bown S, Morden A, Coady T, Logan RF. Prevention of hypoxaemia during upper-gastrointestinal endoscopy by means of oxygen via nasal cannulae. Lancet. 1987 May 2;1(8540):1022-4. doi: 10.1016/s0140-6736(87)92282-3.

  PMID: 2883355 BACKGROUND

• Terblanche NCS, Middleton C, Choi-Lundberg DL, Skinner M. Efficacy of a new dual channel laryngeal mask airway, the LMA(R)Gastro Airway, for upper gastrointestinal endoscopy: a prospective observational study. Br J Anaesth. 2018 Feb;120(2):353-360. doi: 10.1016/j.bja.2017.11.075. Epub 2017 Dec 1.

  PMID: 29406183 BACKGROUND

• King AB, Alvis BD, Hester D, Taylor S, Higgins M. Randomized trial of a novel double lumen nasopharyngeal catheter versus traditional nasal cannula during total intravenous anesthesia for gastrointestinal procedures. J Clin Anesth. 2017 May;38:52-56. doi: 10.1016/j.jclinane.2017.01.025. Epub 2017 Jan 22.

  PMID: 28372678 BACKGROUND

• Hung KC, Chang YJ, Chen IW, Soong TC, Ho CN, Hsing CH, Chu CC, Chen JY, Sun CK. Efficacy of high flow nasal oxygenation against hypoxemia in sedated patients receiving gastrointestinal endoscopic procedures: A systematic review and meta-analysis. J Clin Anesth. 2022 May;77:110651. doi: 10.1016/j.jclinane.2022.110651. Epub 2022 Jan 12.

  PMID: 35030538 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomly assign participants to the standard nasal catheter oxygenation group and the endoscopy mask oxygen inhalation group

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 17, 2023
• Study Start: October 18, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 8, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After December 2024
• Access Criteria: Any project applicant

Locations

CN (5)