NCT06273319

Brief Summary

To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

January 12, 2024

Last Update Submit

February 15, 2024

Conditions

Gastric DiseaseGastric Distress

Keywords

Desaturationoxygen therapySedoanalgesia

Outcome Measures

Primary Outcomes (1)

  • Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%

    Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%

    Up to 24 weeks

Study Arms (2)

Group 1: Patients who will receive 15 litres oxygen therapy

PLACEBO COMPARATOR

: Patients who will receive 15 litres oxygen therapy, will be applied throughout the transaction.Patient saturation and complications such as bronchospasm and laryngospasm respiratory arrest will be recorded throughout the procedure.

Drug: OXYGEN THERAPY

Group 2: Patients who will receive 30 litres oxygen therapy

ACTIVE COMPARATOR

Patients who will receive 30 litres oxygen therapy,will be applied throughout the transaction.Patient saturation and complications such as bronchospasm and laryngospasm respiratory arrest will be recorded throughout the procedure.

Drug: OXYGEN THERAPY

Interventions

OXYGEN THERAPYDRUG

15 AND 30 LT OXYGEN TREATMENT

Group 1: Patients who will receive 15 litres oxygen therapyGroup 2: Patients who will receive 30 litres oxygen therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • PATIENTS WHO WILL HAVE ENDOSCOPY AND OR COLONOSCOPY

You may not qualify if:

  • Chronic obstructive pulmonary disease Having low saturation Lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu universitesi

Malatya, 44050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomach Diseases

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Central Study Contacts

DUYGU DEMIROZ, dr

CONTACT

+905319504421drduygudemiroz@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
2
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 22, 2024

Study Start

March 15, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

TU(1)