Is Effective Preoxygenation in Elderly Patients Related to Position?

Anesthesia Intubation Complication Clinical Trial

Official title:

Is Effective Preoxygenation in Elderly Patients Related to Position?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659758
• Other study ID #: E1-22-2775
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 19, 2023

Study information

• Verified date: July 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of the head-up position of 20 and 30 degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in elderly patients compared to the supine position.

Description:

Patients will be randomized into 3 groups. The patients will lay in the supine position, in the control group and 20 and 30 degrees head up position in other two groups. Each patient will be preoxygenated with well fitting anaesthesia face mask with FiO2 of 100% at least 6L of flow until the ETO2 reaches concentration of 85%. The angle (20 or 30 degrees) formed by the patients' bodies (hips and feet parallel to the ground, lifting the back from the ground plane) with the ground will be measured with a spirit level, angle meter, and confirmed with a smartphone application. The time to reach ETO2 85% by starting preoxygenation in patients will be measured and recorded with a stopwatch. When the target is reached, anesthesia induction will be performed and the patients will be intubated. After the start of the intubation attempt, the stopwatch will be started again, after intubation, the patient will be ventilated with a balloon once and the location of the tube will be confirmed, the circuit will be separated and SpO2 will be expected to go down to the level of 92 % and recorded during this time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

• Age above 65 years

• ASA 1-2

Exclusion Criteria:

• heart failure

• uncooperative

• patients refusing well fitting face mask before reaching EtO2 85%

• chronic lung disease

• anemia (hb<8gr/dl)

• BMI>40

• neurological sequela

Related Conditions & MeSH terms

• Anesthesia Intubation Complication

Intervention

Procedure:
• Head up positioning during preoxygenation
patients will be preoxygenated in head up position

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time ETO2 85%	Time to reach ETO2 85 %	Time between placement of face mask and end tidal oxygen concentration reaches 85 %
Secondary	Desaturation time	Time to reach the Spo2 of 92 % after intubation	Time between initiation laryngoscopy for endotracheal intubation and peripheral oxygen saturation reaches 92 % measured by pulseoxymeter