Obstructive Sleep ApneaNCT03215121
Mask Study: One-handed vs. Two Handed Technique in Children
A study testing One handed mask airway, switch to two hands, Two handed mask airway + jaw thrust and Two handed mask airway, switch to one hand in people with Obstructive Sleep Apnea, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
During induction of anesthesia in children, the investigators have observed significant variability in mask holding technique at our institution among different anesthesia practitioners. Some hold the face mask using one hand and others use two hands. Read more about this study
- Who is it for?
- Ages 1 year to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- One handed mask airway, switch to two hands, Two handed mask airway + jaw thrust and Two handed mask airway, switch to one hand
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 22 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 1 to 8 years of age Scheduled for Tonsillectomy \& adenoidectomy Documented evidence of obstructive sleep apnea ASA I and II
Who cannot join
- Children with abnormal airway anatomy ASA III and over
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours/A I duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Comparative Evaluation of One Handed Versus Two Handed Mask Holding Techniques in Children During Induction of Anesthesia
During induction of anesthesia in children, the investigators have observed significant variability in mask holding technique at our institution among different anesthesia practitioners. Some hold the face mask using one hand and others use two hands. The aim of our study is to comparatively evaluate the extent of airway obstruction in children whilst anesthetic mask is held with one hand with jaw thrust versus mask held using two hands with chin lift by anesthesia provider during induction of anesthesia in children.
Read the detailed description
In a prospective, randomized and controlled study, 60 children with documented obstructive sleep apnea (from sleep study or history obtained from the parent of bothersome snoring, witnessed apnea which interrupts the snoring and/or gasping and choking sensations that arouse the patient from sleep) due to enlarged tonsils and adenoid scheduled for tonsillectomy and adenoidectomy surgery will be enrolled in the study. Children will be randomly divided in three groups of 20 each based on the induction technique used:
Group --1: Induction of anesthesia started as follows while children are breathing spontaneously: One handed mask airway + chin lift - 20 sec and then switch to two hands + jaw thrust - 20 sec
Group 2 - Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec
Group 3 - Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 20 sec and then switch to one hand + chin lift- 20 sec
Premedication with midazolam as per standard protocol, will be administered prior to taking the patients to the operating room. Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced. Addition of sevoflurane will be recorded as the start of induction. The provider will hold the mask as randomized, one hand with switch to two hands for Group 1 patients, two hands for Group 2 patients and two hands with switch to one hand for Group 3 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters stated below. The initial mask management will be performed for 20 seconds.
After another 20 seconds (50 seconds from the start of induction), mask holding will switch to two hands for 20 seconds. In Group 2 patients mask will be held with two hands for 40 seconds. No oropharyngeal or nasopharyngeal airway will be placed during the study period. In Group 3 patients, mask will initially be held with two hands for 20 seconds, with switch to one hand for 20 seconds.
In the investigators clinical experience, the rate of obstructive symptoms with one hand ventilation approaches 100% and obstructive symptoms with two hands ventilation approaches 0%. Using this ratio data for a power analysis to determine sample size yielded 4 subjects per group. As this is probably unreasonably low, the ratios were adjusted to 75% for one hand and 25% for two hand ventilation, which yielded 18 subjects per group to achieve an alpha of 95%, and beta of 80%. With the potential for case dropout, the sample sizes for this study were set at 20 per group to reasonably ensure statistical significance. Given that approximately 80 cases of tonsillectomy and adenoidectomy cases are performed due to obstruction a year, this sample size should be easily obtainable. Randomization of patient assignment to the groups will be accomplished by graph pad quickcalcs.
(http://www.graphpad.com/quickcalcs/randomize1.cfm).
Continuous variables, times and ratio data will be analyzed by t test and nominal data by chi square.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- One handed mask airway, switch to two hands, Two handed mask airway + jaw thrust, Two handed mask airway, switch to one hand
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One handed mask airway, switch to two handsProcedure or surgery
Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, one hand mask airway with switch to two hand for Group 1 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. The initial mask management will be performed for 20 seconds.
After another 20 seconds (50 seconds from the start of induction), in Group one, the mask holding will switch to two hands for 20 seconds.
Two handed mask airway + jaw thrustProcedure or surgery
Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, two hands for Group two patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. In Group 2 patient's mask will be held with two hands first for 40 seconds.
Two handed mask airway, switch to one handProcedure or surgery
Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, two hands for Group 3 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. The initial mask management will be performed for 20 seconds.
After another 20 seconds (50 seconds from the start of induction), in Group 3, the mask holding will switch to one hand for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| One handed mask airway, switch to two hands | Active comparator | Induction of anesthesia started as follows while children are breathing spontaneously: One handed mask airway + chin lift - 20 sec and then switch to two hands + jaw thrust - 20 sec Receives: Procedure: One handed mask airway, switch to two hands |
| Two handed mask airway + jaw thrust | Active comparator | Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec Receives: Procedure: Two handed mask airway + jaw thrust |
| Two handed mask airway, switch to one hand | Active comparator | Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 20 sec and then switch to one hand + chin lift - 20 sec Receives: Procedure: Two handed mask airway, switch to one hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work of breathing
Phase angle
Measured: 20 - 40 seconds
Secondary outcomes (5)
Airway Obstruction Rating Scale 0 - 3
Presence of airway obstruction:
0= No obstruction; 1=Good gas exchange with noisy breathing, no retractions; 2=Mild retractions with diminished air flow; 3=Severe retractions with minimal/no air flow
Measured: 20-40 seconds
Laryngospasm
Indicate presence: yes/no
Measured: 20-40 seconds
Breath holding
Indicate presence: yes/no
Measured: 20-40 seconds
Labored breathing
labored breathing index (RCI)
Measured: 20-40 seconds
Rib cage movement
%Rib Cage movement (%RC)
Measured: 20-40 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Apr 2018
- Primary completion31 Aug 2019
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Childrenwith documented obstructive sleep apnea (by sleep study or history obtained from the parent) due to enlarged tonsils and adenoid scheduled for tonsillectomy and adenoidectomy surgery will be enrolled in the study. Children will be randomly divided in two groups of 20 each based on the induction technique used: Group --1: Induction of anesthesia started as follows while children are breathing spontaneously: One handed mask airway + chin lift - 20 sec and then switch to two hands + jaw thrust - 20 sec Group - 2: Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec. Group 3 - Induction of anesthesia started as follows while children are breathing spontaneously. Two handed mask airway + jaw thrust - 20 sec. then switch to one hand + chin lift - 20 sec.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesh Choudhry, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215121
- Sponsor's protocol ID
- 1065828-2
- Status last verified
- Jan 2020
- First submitted
- 7 Jul 2017
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Keidan I, Fine GF, Kagawa T, Schneck FX, Motoyama EK. Work of breathing during spontaneous ventilation in anesthetized children: a comparative study among the face mask, laryngeal mask airway and endotracheal tube. Anesth Analg. 2000 Dec;91(6):1381-8. doi: 10.1097/00000539-200012000-00014.
PubMed 11093984von Ungern-Sternberg BS, Erb TO, Reber A, Frei FJ. Opening the upper airway--airway maneuvers in pediatric anesthesia. Paediatr Anaesth. 2005 Mar;15(3):181-9. doi: 10.1111/j.1460-9592.2004.01534.x. No abstract available.
PubMed 15725313Litman RS, Kottra JA, Berkowitz RJ, Ward DS. Upper airway obstruction during midazolam/nitrous oxide sedation in children with enlarged tonsils. Pediatr Dent. 1998 Sep-Oct;20(5):318-20.
PubMed 9803430Rahman T, Page R, Page C, Bonnefoy JR, Cox T, Shaffer TH. pneuRIPTM: A Novel Respiratory Inductance Plethysmography Monitor. J Med Device. 2017 Mar;11(1):0110101-110106. doi: 10.1115/1.4035546. Epub 2017 Jan 24.
PubMed 28289485Kheterpal S. It's About Time. Anesthesiology. 2017 Jan;126(1):4-5. doi: 10.1097/ALN.0000000000001408. No abstract available.
PubMed 27811484Sato S, Hasegawa M, Okuyama M, Okazaki J, Kitamura Y, Sato Y, Ishikawa T, Sato Y, Isono S. Mask Ventilation during Induction of General Anesthesia: Influences of Obstructive Sleep Apnea. Anesthesiology. 2017 Jan;126(1):28-38. doi: 10.1097/ALN.0000000000001407.
PubMed 27811485Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.
PubMed 10781266Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007.
PubMed 17065880Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
PubMed 19293691
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of One Handed Versus Two Handed Mask Holding Techniques in Children During Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT03215121
- Acronym / sponsor ID
- 1065828-2
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During induction of anesthesia in children, the investigators have observed significant variability in mask holding technique at our institution among different anesthesia practitioners. Some hold the face mask using one hand and others use two hands. The aim of our study is to comparatively evaluate the extent of airway obstruction in children whilst anesthetic mask is held with one hand with jaw thrust versus mask held using two hands with chin lift by anesthesia provider during induction of anesthesia in children.
Detailed description
In a prospective, randomized and controlled study, 60 children with documented obstructive sleep apnea (from sleep study or history obtained from the parent of bothersome snoring, witnessed apnea which interrupts the snoring and/or gasping and choking sensations that arouse the patient from sleep) due to enlarged tonsils and adenoid scheduled for tonsillectomy and adenoidectomy surgery will be enrolled in the study. Children will be randomly divided in three groups of 20 each based on the induction technique used:
Group --1: Induction of anesthesia started as follows while children are breathing spontaneously: One handed mask airway + chin lift - 20 sec and then switch to two hands + jaw thrust - 20 sec
Group 2 - Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec
Group 3 - Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 20 sec and then switch to one hand + chin lift- 20 sec
Premedication with midazolam as per standard protocol, will be administered prior to taking the patients to the operating room. Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced. Addition of sevoflurane will be recorded as the start of induction. The provider will hold the mask as randomized, one hand with switch to two hands for Group 1 patients, two hands for Group 2 patients and two hands with switch to one hand for Group 3 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters stated below. The initial mask management will be performed for 20 seconds.
After another 20 seconds (50 seconds from the start of induction), mask holding will switch to two hands for 20 seconds. In Group 2 patients mask will be held with two hands for 40 seconds. No oropharyngeal or nasopharyngeal airway will be placed during the study period. In Group 3 patients, mask will initially be held with two hands for 20 seconds, with switch to one hand for 20 seconds.
In the investigators clinical experience, the rate of obstructive symptoms with one hand ventilation approaches 100% and obstructive symptoms with two hands ventilation approaches 0%. Using this ratio data for a power analysis to determine sample size yielded 4 subjects per group. As this is probably unreasonably low, the ratios were adjusted to 75% for one hand and 25% for two hand ventilation, which yielded 18 subjects per group to achieve an alpha of 95%, and beta of 80%. With the potential for case dropout, the sample sizes for this study were set at 20 per group to reasonably ensure statistical significance. Given that approximately 80 cases of tonsillectomy and adenoidectomy cases are performed due to obstruction a year, this sample size should be easily obtainable. Randomization of patient assignment to the groups will be accomplished by graph pad quickcalcs.
(http://www.graphpad.com/quickcalcs/randomize1.cfm).
Continuous variables, times and ratio data will be analyzed by t test and nominal data by chi square.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Childrenwith documented obstructive sleep apnea (by sleep study or history obtained from the parent) due to enlarged tonsils and adenoid scheduled for tonsillectomy and adenoidectomy surgery will be enrolled in the study. Children will be randomly divided in two groups of 20 each based on the induction technique used: Group --1: Induction of anesthesia started as follows while children are breathing spontaneously: One handed mask airway + chin lift - 20 sec and then switch to two hands + jaw thrust - 20 sec Group - 2: Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec. Group 3 - Induction of anesthesia started as follows while children are breathing spontaneously. Two handed mask airway + jaw thrust - 20 sec. then switch to one hand + chin lift - 20 sec.
| Arm | Type | Receives |
|---|---|---|
| One handed mask airway, switch to two hands | Active comparator | Procedure: One handed mask airway, switch to two handsInduction of anesthesia started as follows while children are breathing spontaneously: One handed mask airway + chin lift - 20 sec and then switch to two hands + jaw thrust - 20 sec |
| Two handed mask airway + jaw thrust | Active comparator | Procedure: Two handed mask airway + jaw thrustInduction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec |
| Two handed mask airway, switch to one hand | Active comparator | Procedure: Two handed mask airway, switch to one handInduction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 20 sec and then switch to one hand + chin lift - 20 sec |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Between 1 to 8 years of age Scheduled for Tonsillectomy \& adenoidectomy Documented evidence of obstructive sleep apnea ASA I and II
Key exclusion criteria (1 listed)
- Children with abnormal airway anatomy ASA III and over
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One handed mask airway, switch to two handsPrior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning. Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, one hand mask airway with switch to two hand for Group 1 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. The initial mask management will be performed for 20 seconds. After another 20 seconds (50 seconds from the start of induction), in Group one, the mask holding will switch to two hands for 20 seconds. | Procedure or surgery | One handed mask airway, switch to two hands |
| Two handed mask airway + jaw thrustPrior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning. Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, two hands for Group two patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. In Group 2 patient's mask will be held with two hands first for 40 seconds. | Procedure or surgery | Two handed mask airway + jaw thrust |
| Two handed mask airway, switch to one handPrior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning. Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, two hands for Group 3 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. The initial mask management will be performed for 20 seconds. After another 20 seconds (50 seconds from the start of induction), in Group 3, the mask holding will switch to one hand for 20 seconds. | Procedure or surgery | Two handed mask airway, switch to one hand |
Primary outcome
Work of breathing
Time frame: 20 - 40 seconds
Phase angle
5 secondary outcomes
Airway Obstruction Rating Scale 0 - 3
Time frame: 20-40 seconds
Laryngospasm
Time frame: 20-40 seconds
Breath holding
Time frame: 20-40 seconds
Labored breathing
Time frame: 20-40 seconds
Rib cage movement
Time frame: 20-40 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Background: PubMed 11093984Keidan I, Fine GF, Kagawa T, Schneck FX, Motoyama EK. Work of breathing during spontaneous ventilation in anesthetized children: a comparative study among the face mask, laryngeal mask airway and endotracheal tube. Anesth Analg. 2000 Dec;91(6):1381-8. doi: 10.1097/00000539-200012000-00014.
- Background: PubMed 15725313von Ungern-Sternberg BS, Erb TO, Reber A, Frei FJ. Opening the upper airway--airway maneuvers in pediatric anesthesia. Paediatr Anaesth. 2005 Mar;15(3):181-9. doi: 10.1111/j.1460-9592.2004.01534.x. No abstract available.
- Background: PubMed 9803430Litman RS, Kottra JA, Berkowitz RJ, Ward DS. Upper airway obstruction during midazolam/nitrous oxide sedation in children with enlarged tonsils. Pediatr Dent. 1998 Sep-Oct;20(5):318-20.
- Background: PubMed 28289485Rahman T, Page R, Page C, Bonnefoy JR, Cox T, Shaffer TH. pneuRIPTM: A Novel Respiratory Inductance Plethysmography Monitor. J Med Device. 2017 Mar;11(1):0110101-110106. doi: 10.1115/1.4035546. Epub 2017 Jan 24.
- Background: PubMed 27811484Kheterpal S. It's About Time. Anesthesiology. 2017 Jan;126(1):4-5. doi: 10.1097/ALN.0000000000001408. No abstract available.
- Background: PubMed 27811485Sato S, Hasegawa M, Okuyama M, Okazaki J, Kitamura Y, Sato Y, Ishikawa T, Sato Y, Isono S. Mask Ventilation during Induction of General Anesthesia: Influences of Obstructive Sleep Apnea. Anesthesiology. 2017 Jan;126(1):28-38. doi: 10.1097/ALN.0000000000001407.
- Background: PubMed 10781266Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.
- Background: PubMed 17065880Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007.
- Background: PubMed 19293691Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One handed mask airway, switch to two hands, Two handed mask airway + jaw thrust and Two handed mask airway, switch to one hand in people with Obstructive Sleep Apnea, run by Nemours Children's Clinic at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work of breathing (time frame: 20 - 40 seconds). 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 NCT03215121, which also lists 9 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 23 Jan 2020.