NCT07565259

Brief Summary

This study explores whether simply guiding patients to breathe slowly and calmly before anesthesia can help improve oxygen levels and keep them safe for longer during induction. The investigators included 120 participants scheduled for elective surgery, comparing routine preoxygenation with a gentle, coached breathing technique using steady inhalation and exhalation. The investigator focused mainly on how long participants could safely tolerate apnea, while also examining oxygen levels, vital signs, and anxiety.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress57%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 7, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2026

Expected
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 10, 2026

Last Update Submit

April 27, 2026

Conditions

Preoxygenation

Keywords

PreoxygenationVerbal breathing coachingSafe apnea timeGeneral anesthesia inductionPatient safety

Outcome Measures

Primary Outcomes (1)

  • Oxygen saturation

    time from loss of consciousness to SpO₂ reaching 92%

    3 minutes

Secondary Outcomes (3)

  • End-tidal Oxygen concentration

    3 minutes

  • Mean arterial pressure

    3 minutes

  • Heart rate

    3 minutes

Study Arms (2)

Control Group: Standard Preoxygenation

ACTIVE COMPARATOR

receives standard preoxygenation (routine care with no additional coaching).

Procedure: Verbal Breathing Coaching

Intervention Group: Verbal Breathing Coaching

EXPERIMENTAL

receives structured verbal breathing coaching in addition to standard preoxygenation.

Procedure: Verbal Breathing Coaching

Interventions

Verbal Breathing CoachingPROCEDURE

In addition to standard preoxygenation, patients receive continuous verbal coaching: "Breathe in slowly through your nose for four seconds" "Now breathe out slowly through your mouth for six seconds" Instructions repeated rhythmically for 3 minutes Delivered by the attending anesthesiologist using a standardized script

Control Group: Standard PreoxygenationIntervention Group: Verbal Breathing Coaching

Eligibility Criteria

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

You may qualify if:

  • Scheduled for elective surgery under general anesthesia with tracheal intubation.
  • BMI \< 35 kg/m²
  • The Ability to understand and follow verbal instructions

You may not qualify if:

  • Patients with an anticipated difficult airway
  • Significant cardiopulmonary disease
  • Pregnancy
  • Emergency surgery
  • Pre-existing hypoxemia (SpO₂ \< 94% on room air)
  • Use of sedative premedication affects respiratory drive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sultan Military Medical City

Riyadh, Saudi Arabia

Location

Related Publications (1)

  • 1. Nimmagadda, U., Salem, M.R., & Joseph, N.J. (2000). Preoxygenation: physiologic basis, benefits, and potential risks. Anesthesiology Clinics of North America, 18(3), 547-563. 2. Tanoubi, I., Drolet, P., & Donati, F. (2009). Optimizing preoxygenation in adults. Canadian Journal of Anesthesia, 56(6), 449-466. 3. Baraka, A., Taha, S.K., El-Khatib, M.F. (1999). Preoxygenation: comparison of maximal breathing and tidal volume breathing techniques. Anesthesia & Analgesia, 89(3), 653-656. 4. Gambee, A.M., Hertzka, R.E., & Fisher, D.M. (1987). Preoxygenation techniques: comparison of three minutes tidal volume breathing and eight deep breaths over 60 seconds. Anesthesiology, 66(6), 816-819. 5. O'Brien, J., Batterham, A.M., & Parkin, P. (2011). Coaching respiratory techniques improves gas exchange and tidal volume during voluntary breathing tasks. Respiration Physiology & Neurobiology, 177(2), 153-158. 6. Weingart, S.D., Levitan, R.M. (2012). Preoxygenation and prevention of desaturation during emergency airway management. Annals of Emergency Medicine, 59(3), 165-175.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomized into a two equal groups each will be 60 participants, using a computer-generated random sequence. Allocation will be concealed in sealed opaque envelopes opened immediately before preoxygenation.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: prospective, randomized, parallel-group controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CONSULTANT ANESTHESIA, Principal Investigator

Study Record Dates

First Submitted

April 10, 2026

First Posted

May 4, 2026

Study Start

February 7, 2026

Primary Completion (Estimated)

June 25, 2026

Study Completion (Estimated)

July 14, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)