Head Elevation During Pre-oxygenation Can Delay Desaturat... | NCT05688722

Studies
Head Elevation During Pre-oxygenation Can Delay Desaturation Time

NCT05688722

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Jan 18, 2023Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Surgery
Desaturation of Blood
Apnea

Interventions

Supine position
20 degree head elevation position
30 degree head elevation position
45 degree head elevation position

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

May 31, 2021Actual

Completion Date

May 31, 2021Actual

First Submitted Date

Jan 9, 2023

First Submission Date that Met QC Criteria

Jan 9, 2023

First Posted Date

Jan 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2023

Last Update Posted Date

Jan 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ratna Farida Soenarto, Principal Investigator, Indonesia UniversityPrincipal Investigator

Lead Sponsor

Indonesia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a randomized-controlled trial study comparing the association between several degree of head elevation and conventional position during pre-oxygenation to desaturation time in patients undergo endotracheal intubation with general anesthesia

Detailed Description

Preoxygenation anesthesia induction is an important part of airway management to reduce the risk of hypoxemia when the patient is apneic. The effectivity of preoxygenation is influenced by several things such as patient's head position. This study aimed to compare preoxygenation with head elevation 20°, 30° and 45° and conventional position to the time of desaturation before endotracheal intubation in patients undergoing general anesthesia. This was a randomized clinical trial of 56 patients, divided into four groups (conventional or 0° head elevation group, 20° head elevation group, 30° head elevation and 45° head elevation group). All subject was preoxygenated for 3 minutes with 100% oxygen. Induction of anesthesia was started with fentanyl, propofol, followed by rocuronium after the patient lost consciousness. Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes. There was a significant difference in mean desaturation time among the four groups (p = 0.011). The most significant different was in 45o head elevation group (p < 0.05). . In patients undergoing general anesthesia, pre-oxygenation with head elevation 20°, 30° and 45° slows down the time for desaturation before endotracheal intubation compared to the conventional position. The 45° head elevation has the best result.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Patient positioned in supine conventional position	Procedure: Supine position
20 degree head elevation	Active Comparator	Patient positioned in 20 degree head elevation position	Procedure: 20 degree head elevation position
30 degree head elevation	Active Comparator	Patient positioned in 30 degree head elevation position	Procedure: 30 degree head elevation position
45 degree head elevation	Active Comparator	Patient positioned in 45 degree head elevation position	Procedure: 45 degree head elevation position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supine position	Procedure	Patients preoxygenated in supine position before endotracheal intubation	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Desaturation time	Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes	Right after induction until reach oxygen saturation 93% or 5 minutes time limit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

undergo endotracheal intubation with general anesthesia for elective surgery
aged 18-60 years old
ASA physical status 1-2 preoperatively

Exclusion Criteria:

Patients with difficult airway, cardiopulmonary disease, anemia, grade II obesity, pregnant, history of hypersensitivity to induction agents
Patients did not give consent to follow the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ratna F Soenarto, Consultant	Indonesia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cipto Mangunkusumo Central National Hospital		Jakarta Pusat	DKI Jakarta	10430	Indonesia

Condition Browse Module

MeSH Terms

ID	Term
D001049	Apnea

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016683	Supine Position

Ancestor Terms

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided