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Deep Tracheal ExtubationNCT07918885

High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients

A study testing HFNO-Assisted Deep Extubation and Conventional Awake Extubation in people with Deep Tracheal Extubation, run by Fayoum University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective, randomized controlled trial aims to compare two methods of tracheal extubation after general anesthesia in adults with morbid obesity undergoing elective laparoscopic surgery. A total of 120 patients will be randomly assigned to one of two groups. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Deep Tracheal Extubation
What is being tested?
HFNO-Assisted Deep Extubation and Conventional Awake Extubation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Nov 2026to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients aged 18-60 years. • BMI ≥ 40 kg/m² (morbidly obese). • American Society of Anesthesiologists (ASA) physical status classification II-III.
  • Patients scheduled for elective laparoscopic surgery .
  • Mallampati score I or II (anticipated non-difficult airway).

Who cannot join

  • Patients with known or anticipated difficult airway (Mallampati III-IV, previous history of difficult intubation, limited mouth opening, or cervical spine immobility).
  • Patients with severe obstructive sleep apnea (OSA) on home CPAP/BiPAP therapy who cannot tolerate nasal cannula delivery systems.
  • Active gastroesophageal reflux disease (GERD) with aspiration risk.
  • Patients with significant cardiovascular disease (NYHA class III-IV heart failure, unstable angina, or recent myocardial infarction within 6 months).
  • Patients with severe pulmonary disease (FEV₁ < 50% predicted, chronic hypercapnia, or oxygen-dependent respiratory failure).
  • Emergency surgical procedures.
  • Patients with nasal obstruction, facial deformity, or conditions precluding HFNO delivery.
  • Pregnant patients.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ahmed Maged Nadar, M. B. B. Ch contact

01019510974

Ahmed.magednadar@yahoo.com

Mina Mahrous Sobhy, M.D contact

01025273637

mms12@fayoum.edu.eg

About this study

Official title: HFNO-Assisted 'No-Touch' Deep Extubation Versus Conventional Awake Extubation in Morbidly Obese Patients Undergoing Elective Laparoscopic Surgery: A Prospective Randomized Controlled Trial

This prospective, randomized controlled trial aims to compare two methods of tracheal extubation after general anesthesia in adults with morbid obesity undergoing elective laparoscopic surgery.

A total of 120 patients will be randomly assigned to one of two groups. In the first group, the breathing tube will be removed while the patient remains deeply anesthetized, followed immediately by heated and humidified high-flow nasal oxygen (HFNO). Patients will then be allowed to awaken without unnecessary stimulation. In the second group, the breathing tube will be removed after the patient is fully awake, followed by conventional oxygen therapy through a face mask.

Read more

The primary objective is to determine whether HFNO-assisted deep extubation reduces the incidence of coughing during the first 15 minutes after extubation compared with conventional awake extubation.

The study will also assess respiratory complications, the need for airway interventions, hemodynamic changes, recovery times, and adverse events associated with the two extubation approaches.

The findings may help inform airway management strategies during recovery from general anesthesia in patients with morbid obesity.

Being tested
HFNO-Assisted Deep Extubation, Conventional Awake Extubation
Keywords
High-Flow Nasal Oxygen, Deep Tracheal Extubation, No-Touch Extubation, Awake Tracheal Extubation, Emergence Cough, Laparoscopic Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFNO-Assisted Deep ExtubationProcedure or surgery

    At the end of surgery, following adequate recovery from neuromuscular blockade (train-of-four ratio ≥0.9) and confirmation of adequate spontaneous ventilation, the endotracheal tube will be removed while the patient remains deeply anesthetized (end-tidal sevoflurane concentration ≥1.0 age-adjusted MAC). Immediately after extubation, heated and humidified high-flow nasal oxygen (HFNO) will be administered through nasal cannulae at an initial flow rate of 40 L/min, which may be increased to 60 L/min as clinically indicated. The initial FiO₂ will be 1.0 and subsequently titrated to maintain SpO₂ ≥92%. HFNO will continue for 60 minutes in the post-anesthesia care unit. Unnecessary stimulation during emergence will be avoided.

  • Conventional Awake ExtubationProcedure or surgery

    At the end of surgery, general anesthesia will be discontinued, and tracheal extubation will be performed after the patient regains consciousness, responds to verbal commands, and fulfills standard extubation criteria, including adequate spontaneous ventilation and neuromuscular recovery (train-of-four ratio ≥0.9). Following extubation, supplemental oxygen will be administered via a simple face mask at 8-10 L/min for 60 minutes in the post-anesthesia care unit.

Study groups in NCT07918885
Study groupRoleWhat they receive
Group D (Deep Extubation + HFNO Group)ExperimentalPatients allocated to this group will undergo tracheal extubation while deeply anesthetized, after confirmation of adequate spontaneous ventilation and neuromuscular recovery (train-of-four ratio ≥0.9). Immediately after extubation, heated and humidified high-flow nasal oxygen (HFNO) will be administered at an initial flow rate of 40 L/min, adjustable up to 60 L/min as clinically indicated. Oxygen concentration will be titrated to maintain SpO₂ ≥92%. HFNO will be continued for 60 minutes in the post-anesthesia care unit (PACU).
Receives: Procedure: HFNO-Assisted Deep Extubation
Group A (Awake Extubation Group)Active comparatorPatients allocated to this group will undergo conventional awake tracheal extubation after discontinuation of general anesthesia, once they regain consciousness, respond to verbal commands, and meet standard extubation criteria, including adequate spontaneous ventilation and neuromuscular recovery (train-of-four ratio ≥0.9). Following extubation, supplemental oxygen will be administered through a simple face mask at 8-10 L/min for 60 minutes in the post-anesthesia care unit (PACU).
Receives: Procedure: Conventional Awake Extubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Coughing During Extubation and Early Emergence

    The proportion of patients experiencing at least one episode of coughing during tracheal extubation or within the first 15 minutes after extubation. Coughing will be recorded as a binary outcome (yes/no) for each participant, and the incidence will be compared between the two study groups.

    Measured: During tracheal extubation and up to 15 minutes post-extubation

Secondary outcomes (8)
  1. Severity of Coughing During Extubation and Early Emergence

    Cough severity will be assessed using the Modified Minogue Cough Scale, a four-grade ordinal scale: Grade 1, no coughing; Grade 2, mild coughing; Grade 3, moderate coughing; and Grade 4, severe coughing. Cough severity will be assessed during tracheal extubation and throughout the first 15 minutes after extubation.

    Measured: During tracheal extubation and up to 15 minutes post-extubation

  2. Incidence of Laryngospasm

    The proportion of participants who experience laryngospasm during emergence from general anesthesia or within the first 60 minutes after tracheal extubation. Laryngospasm will be recorded as present or absent (yes/no), and any episode will be classified as partial or complete.

    Measured: During emergence and up to 60 minutes after tracheal extubation

  3. Incidence of Breath-Holding or Apnea

    The proportion of participants experiencing at least one episode of breath-holding or apnea during emergence from general anesthesia or within the first 60 minutes after tracheal extubation. Events will be recorded as present or absent (yes/no), with the type of respiratory event documented when applicable.

    Measured: During emergence and up to 60 minutes after tracheal extubation

  4. Heart Rate During Emergence and Early Postoperative Recovery

    Heart rate (HR), measured in beats per minute (bpm), will be recorded at pre-induction baseline, immediately after tracheal extubation, and at 5, 10, 15, 30, and 60 minutes post-extubation. Heart rate measurements at the predefined time points will be compared between the two study groups.

    Measured: At pre-induction baseline, immediately after tracheal extubation, and at 5, 10, 15, 30, and 60 minutes post-extubation.

  5. Mean Arterial Pressure During Emergence and Early Postoperative Recovery

    Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), will be recorded at pre-induction baseline, immediately after tracheal extubation, and at 5, 10, 15, 30, and 60 minutes post-extubation. Mean arterial pressure measurements at the predefined time points will be compared between the two study groups.

    Measured: At pre-induction baseline, immediately after tracheal extubation, and at 5, 10, 15, 30, and 60 minutes post-extubation.

  6. Time From Extubation to Full Orientation

    From tracheal extubation until achievement of full orientation, assessed for up to 60 minutes after extubation.

    Measured: From tracheal extubation until full orientation during emergence

  7. Length of Stay in the Post-Anesthesia Care Unit

    From admission to the post-anesthesia care unit (PACU) until PACU discharge, assessed for up to 4 hours after admission.

    Measured: From PACU admission to PACU discharge

  8. Incidence of Bronchospasm

    The proportion of participants experiencing at least one clinically diagnosed episode of bronchospasm during emergence from general anesthesia or within the first 60 minutes after tracheal extubation. Bronchospasm will be recorded as present or absent (yes/no).

    Measured: During emergence and up to 60 minutes after tracheal extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm, parallel-group randomized controlled trial with 1:1 allocation. A total of 120 participants will be assigned to two groups of 60 participants each.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07918885
Sponsor's protocol ID
M963
Status last verified
Oct 2026
First submitted
26 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is currently no plan to share individual participant data with external researchers. Study findings will be disseminated through scientific publications and presentations.

Publications

  • 2. Waheed Z, Amatul-Hadi F, Kooner A, Bhatti J, Afzal M, Ahmed R, et al. General anesthetic care of obese patients undergoing surgery: a review of current anesthetic considerations and recent advances. Cureus. 2023;15(7):e41565. 3. Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Practice & Research: Clinical Anaesthesiology. 2010;24(2):211-225. 4. Rosén J, Frykholm P, Fors D. Effect of high-flow nasal oxygen on postoperative oxygenation in obese patients: a randomized controlled trial. Health Science Reports. 2022;5(3):e616. 5. Singh PA, Thong SY, Sivasankar R. Airway management in patients suffering from morbid obesity. Saudi Journal of Anaesthesia. 2022;16(3):314-321. 6. Adams JP, Murphy PG. Obesity in anaesthesia and intensive care. British Journal of Anaesthesia. 2000;85(1):91-108. 7. Smith HC, Kinsella SM, Sellers WFS. A comparison of deep versus awake tracheal extubation in adults: a randomized controlled trial. Regional Anesthesia & Pain Medicine. 2024. doi:10.1136/rapm-2024-105362. 8. Abdelmalak BB, Maheshwari A, Mascha EJ. Evaluation of "no touch" extubation technique on airway-related complications during emergence from general anesthesia. Egyptian Journal of Anaesthesia. 2012;28(2):135-141. 9. Wang YK, Li X, Wei SY, Lv X. The effect of high-flow nasal cannula oxygen therapy on preventing hypoxemia during deep sedation extubation after laparoscopic surgery: a prospective randomized controlled trial. BMC Anesthesiology. 2026. doi:10.1186/s12871-026-03735-w. 10. Petkar S, Wanjari D, Priya V. A comprehensive review on high-flow nasal cannula oxygen therapy in critical care: evidence-based insights and future directions. Cureus. 2024;16(8):e66264. 11. Ferrando C, Puig J, Serralta F, Jimenez V, Gutierrez A, García M, et al. High-flow nasal cannula oxygenation reduces postoperative hypoxemia in morbidly obese patients: a randomized controlled trial. Minerva Anestesiologica. 2019;85(10):1062-1070.

  • Hardt K, Wappler F. Anesthesia for Morbidly Obese Patients. Dtsch Arztebl Int. 2023 Nov 17;120(46):779-785. doi: 10.3238/arztebl.m2023.0216.

    PubMed 37874129

Questions about this trial

What is this clinical trial studying?

A study testing HFNO-Assisted Deep Extubation and Conventional Awake Extubation in people with Deep Tracheal Extubation, run by Fayoum University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Maged Nadar, M. B. B. Ch (01019510974, Ahmed.magednadar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Coughing During Extubation and Early Emergence (time frame: During tracheal extubation and up to 15 minutes post-extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07918885, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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